Supporting Statement A 11.10.2021

Supporting Statement A for

NIEHS DERT Extramural Grantee Data Collection Common Form (NIEHS)

OMB # 0925-0757 and expiration date 11/30/2021

Date: September 29, 2021

Check off which applies:

• New

X Revision

• Reinstatement with Change

• Reinstatement without Change

• Extension

• Emergency

• Existing

Federal Government Employee Information:

Name: Project Officer Kristianna Pettibone, PhD

Address: Division of Extramural Research and Training

National Institute of Environmental Health Sciences; 530 Davis Dr., MD KS-13; Morrisville, NC 27560

Telephone: (919) 541- 7752

Fax: (919) 541-4937

Email: pettibonekg@niehs.nih.gov

Table of contents

A. ABSTRACT

A.1 Circumstances Making the Collection of Information Necessary

A.2. Purpose and Use of the Information COLLECTION

A.3 Use of Information Technology and Burden Reduction

A.4 Efforts to Identify Duplication and Use of Similar Information

A.5 Impact on Small Businesses or Other Small Entities

A.6 Consequences of Collecting the Information Less Frequently

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

A.9 Explanation of Any Payment of Gift to Respondents

A.10 Assurance of Confidentiality Provided to Respondents

A.11 Justification for Sensitive Questions

A.12 Estimates of Hour Burden Including Annualized Hourly Costs

A.13 Estimate of Other Total Annual Cost Burden to Respondents or Recordkeepers

A.14 Annualized Cost to the Federal Government

A.15 Explanation for Program Changes or Adjustments

A.16 Plans for Tabulation and Publication and Project Time Schedule

A.17 Reason(s) Display of OMB Expiration Date is Inappropriate

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

Attachments

I. DEGDC Survey November 2021

II. PIA for NIEHS DERT Extramural Grantee Data Collection Survey

III. NIEHS Simplified Data Collection Form 2021

A. Justification

Abstract: The National Institute of Environmental Health Sciences (NIEHS) is requesting a revision of our clearance for the Extramural Grantee Data Collection Survey “Common Form” for use by:

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• National Institute on Deafness and Other Communication Disorders (NIDCD)

• National Institute of Mental Health (NIMH)

• National Institute of Neurological Disorders and Stroke (NINDS)

• National Institute of Environmental Health Sciences (NIEHS)

• National Cancer Institute (NCI)

The authorization for this clearance request is Executive Order 12862 (1993). This data collection effort is strictly to assess extramural community satisfaction with procedures and initiatives. NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS will use a standard data collection survey (Attachment I) for all grantee data collection.

A.1 Circumstances Making the Collection of Information Necessary

The mission of the NIEHS is to reduce the burden of human illness and disability, by understanding how the environment influences the development and progression of human disease. The NIEHS supports a wide variety of research programs directed toward preventing health problems caused by our environment. We fund research across the United States through our extramural funding program. The largest portion of the NIEHS budget goes to fund laboratory research, population-based studies, and training programs at universities, hospitals, businesses, and organizations.

The Division of Extramural Research and Training (DERT) at the NIEHS plans, directs and evaluates the Institute's grant program which supports research and research training in environmental health. It develops program priorities and recommends funding levels to assure maximum utilization of available resources in attainment of Institute objectives. Through cooperative relationships with NIH and with public and private institutions and organizations, the Division maintains an awareness of national research efforts and assesses the need for research and research training in environmental health.

Within DERT, the Program Analysis Branch (PAB) is tasked with:

• Providing guidance in shaping the direction of the portfolio through grant assignment and tracking, and coordination of division activities.

• Conducting long and short-term scientific evaluation and analyses of grant portfolio to provide a basis for priority setting, decision-making, and strategic planning.

• Developing methodologies to conduct impact analyses to assure maximum benefits of research funding.

• Using results of program analyses to recommend areas for program development and to identify emerging emphasis areas for consideration by the Institute Director and advisory groups.

• Communicating high impact science and public health relevance of extramural research.

In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIH must be able collect, analyze and report on data from extramural grantees. PAB must occasionally collect information directly from grantees who are currently receiving funding or who have received funding in the past on topics such as:

• Key scientific outcomes achieved through the research and the impact on the field of environmental health science

• Contribution of research findings to program goals and objectives

• Satisfaction with the program support received

• Challenges and benefits of the funding mechanism used to support the science

• Emerging research areas and gaps in the research

This data collection falls within the mandate of the NIH written in 42 USC 285 l (Section 463 of the Public Health Services Act), as amended by the Health Research Extension Act of 1985.

A.2 Purpose and Use of the Information Collection

Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research.

Without this research, NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS would have little information regarding the impact of its extramural research and training programs, and thus little information on which to base future program decisions.

During the last 3 years the short form has been used most frequently with the Environmental Health Sciences Core Centers Program and Superfund Research Program. The Superfund Research Program receives submissions from 25 grantees per year. The Environmental Health Sciences Core Centers Program receives about 24 submissions annually from grantees with updates on achievements and impacts. The data submitted from these short forms is used to identify and communicate the impacts and achievements of the program with stakeholders, including Congress. We received feedback from the grantees that they would like to have more defined fields in which to enter their data. Grantees also indicated that there were several other activities they would like to report on. In response, we have expanded the list of activities that grantees can report on in the simplified form of the survey, see Attachment III. Any grantee satisfaction or program management data collected through this survey will be used by the ICs to inform future programming decisions.

A.3 Use of Information Technology and Burden Reduction

Because we will be collecting and storing data electronically, we conducted a Privacy Impact Assessment (PIA). A copy of the PIA is included as Attachment II.

Survey respondents will be extramural research and training grant awardees from NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS. We will identify survey respondents by searching an NIH-wide database of extramural research and training grants (IMPAC II). Data collection efforts will target specific research portfolios and only researchers who have been identified as conducting research within a defined portfolio will be asked to participate.

We will send an initial email to the respondents inviting them to participate in the survey. Respondents will have two options for completing the survey. We will provide a web-based system that will allow respondents the option of completing the survey electronically. This option will be encouraged. Data submitted using the electronic system will be transferred automatically to a database. Those grantees without access to the web-based survey can respond using a paper version of the survey. Staff will enter data submitted using paper survey into the database. This process is designed to minimize burden to the respondent and obtain data as efficiently as possible. The survey instrument is provided in Attachment I.

We will review all progress reports and other grantee materials prior to conducting the survey to ensure that we capture all reported impacts and outcomes. This will reduce respondent burden by minimizing duplicate data reporting.

After conducting a Privacy Impact Assessment (PIA) we determined that no questions regarding these topics or any other topic of a sensitive nature are included in this survey. Specifically, no personal identifying information (PII) will be collected. The only information collected is federal contact information, which does not qualify as personal identifying information (PII) according to the E-Government Act of 2002.

A.4 Efforts to Identify Duplication and Use of Similar Information

There is no duplication of data available through other sources. Information collected through this survey is specific to each IC’s grants research portfolio.

A.5 Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this study.

A.6 Consequences of Collecting the Information Less Frequently

NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS will only collect this data one time from grantees in a specific research portfolio.

If we are not able to collect this data, we will be forced to make future program decisions in a vacuum, without being able to consider the impact our programming actions have on grantees and their science.

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This study complies fully with the guidelines of 5 CFR 1320.5. No exceptions to the guidelines are required.

A.8.1 Comments in Response to the Federal Register Notice and

The 60-day Federal Register was published on September 13, 2021, Volume 86, Number 74, page 50897-50898 and allowed 60-days for public comment. No public comments were received.

A.8.2 Efforts to Consult Outside Agency

NIEHS obtained input from representatives of the Food and Drug Administration as well as the Environmental Protection Agency. Researchers from the Battelle Centers for Public Health Research and Evaluation, who have conducted evaluations for NIEHS under contract number HHSP23320045006XI, Task Order HHSP233000015T also provided input on the data collection design, survey instrument, sampling plan, and data collection procedures.

A.9 Explanation of Any Payment of Gift to Respondents

No payment or gift will be made to the respondents.

A.10 Assurance of Confidentiality Provided to Respondents

The NIEHS Privacy Act Officer has reviewed this application and has determined that the Privacy Act is not applicable.

Staff or contractors from NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS will conduct the survey, and tabulate and store the data. ICs will send respondents an email:

• inviting them to participate,

• describing how they were selected,

• stating the purpose of the survey,

• informing them that participation is voluntary,

• providing information about how long the survey will take,

• providing information about how the data will be used, and

• providing a phone number and email address for a data collection liaison who can answer any questions they may have.

Respondents will have the option to skip any question they would prefer not to answer and to quit the survey at any time. They will also be told that no data will be retained that will permit anyone to personally identify them and that no individual information will be presented in any reports. Respondents will not be asked to complete a consent form. Each respondent’s willingness to go to the web link and complete the survey (or complete a hardcopy version) will be interpreted as evidence of implied consent.

To protect the confidentiality of respondents completed hardcopy survey questionnaires will be stored in locked file cabinets. All project files will be password protected and access to the files will be limited to authorized project staff. Surveys entered online will be password protected and will not allow access once the respondent has completed the survey. The web survey will be hosted on a secure server protected with a Secure Sockets Layer (SSL) certificate and 128-bit encryption, the strongest online data encryption protection available. The tracking database with individual contact information will be stored separately from the data. The database will contain IDs only. The tracking database that links IDs to individual information will be destroyed at the end of the project. Project reports will not identify individuals who completed the survey. No names, university names, or personal identifying information will be used in any published reports of this study. Survey reports will present all findings in aggregate so individual responses cannot be identified.

A.11 Justification for Sensitive Questions

No sensitive questions will be asked.

A.12.1 Estimates of Hour Burden Including Annualized Hourly Costs

The total burden hours for screening and survey administration are 740 hours. Because this request covers potential portfolio evaluations conducted by NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS in the next 3 years using both the Common Form and the short form, we have estimated that approximately 1,640 grantees will complete a 30-minute or 10-minute survey. In the event that participants do not have web access, we will provide a paper version of the survey provided in Attachment I.

A.12 – 1 Estimates of Annual Hour Burden

Type of Respondent	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours)	Total Annual Burden Hours
NICHD Grantee	200	1	30/60	100
NIDCD Grantee	200	1	30/60	100
NIMH Grantee	200	1	30/60	100
NINDS Grantee	200	1	30/60	100
NCI Grantee	400	1	30/60	200
NIEHS Grantee (long form)	200	1	30/60	100
NIEHS Grantee (short form)	240	1	10/60	40
Total	1,640	1,640		740

There are no costs to respondents except for their time to participate. The approximate burden over the course of 3 years is 740 hours. The burden estimate is based on pretests along with NIEHS’ experience with surveys with similar administration protocols and lengths. The survey respondents will most likely be scientists and post-secondary professors. The average annual salary for full-time professors in 2021 was approximately $101,320, with variation in salary by rank (https://www.bls.gov/oes/current/oes251042.htm. Salary rate was identified using Occupation Code 25-1042, Biological Sciences Teachers, Postsecondary.) Table A.12-2 summarizes the costs to respondents.

A.12-2. Annual Cost to Respondents

Type of Respondents	Total Annual Burden Hours	Hourly Wage Rate*	Respondent Cost
University Level Professors	740	50.66	$37,488.40
Totals			$37,488.40

* Bureau of Labor Statistics: The General Public rate was obtained from the https://www.bls.gov/oes/current/oes251042.htm, using Occupation Code 25-1042, Biological Sciences Teachers, Postsecondary. We used the Annual Median Wage and divided by 2,000 to estimate the hourly wage rate.

A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

The data collection entails no additional costs to respondents or recordkeepers.

A.14 Annualized Cost to the Federal Government

The annualized cost to the Federal Government is approximately $13,442.20 per data collection activity. (see Estimated Timeline – Table A16-1). This cost includes the salary and benefits of a project officer, and a project analyst for 3 months. The costs for each participating institute (NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS) are estimated in Table below.

Staff	Grade/ Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
NCI Program Analyst	13/5	$117,516	2%		$2,350.32
NICHD Program Analyst	12/5	$98,827	2%		$1,976.54
NIDCD Science Policy Analyst	14/10	$159,286	2%		$3,185.72
NIEHS Program Analyst	12/5	$98,827	2%		$1,976.54
NIMH Info	12/5	$98,827	2%		$1,976.54
NINDS Program Analyst	12/5	$98,827	2%		$1,976.54
Contractor Cost NCI		None
Contractor Cost NICHD		None
Contractor Cost NIDCD		None
Contractor Cost NIEHS		None
Contractor Cost NIMH		None
Contractor Cost NINDS		None
Travel
Other Cost
Total Cost					$13,442.20

*the Salary in table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/DCB.aspx

A.15 Explanation for Program Changes or Adjustments

We are requesting clearance to change the format of the Simplified survey (see attachment III) and to add new fields to the activities or accomplishments reported in the survey. We would also like to expand the list of the types of activities that grantees can report.

After using the open-ended version of the Simplified form and receiving feedback from respondents, we would like to update the format based on feedback from the respondents to provide more structure in the way of defined questions/response fields. The table below summarizes the proposed additions and changes.

Proposed field changes include:

Addition /Change	Field	Reason/Rationale
Addition	Name	To gather contact information if we have a question about a response.
Addition	Email address	To gather contact information if we have a question about a response.
Change	Grant Number (now Program)	For the SRP program only, we have added the ability for respondents to select their grant number from a pull-down list so that they do not have to remember it.
Addition	Material Submitted	Providing respondents an opportunity to share materials they have developed.
Addition /Change	Field	Reason/Rationale
Change List of Activities	Activities	Previous activities included a list of the activities below with open ended responses: Awards Collaborations Community Outreach & Engagement News & Media Partnerships Patents Publications Service on Advisory Boards or Panels Tech Transfer Activities Workshops or Events Activities are now formatted as a drop down box that respondents can select. New fields are indicated with a “*”: Awards Community Partnerships Data Sharing* Interaction with ATSDR* Interaction with EPA* Interaction with State/Local Agencies* Interview/News Stories/Other Press* Interaction with other Agencies/Organizations* Patents Press Releases* Publications Seminars* Service on Advisory Boards or Panels Tech Transfer – Field Studies Tech Transfer – Partnerships Tech Transfer – Validation Studies Workshops/Events Other*
Addition	Other Activity Type Description	Providing a field for respondents to describe other activities.
Addition	Activity Title	Defined field to obtain specific information about the activity title, rather than previous open-ended field.
Addition	Activity Start Month	Defined field for respondent to provide timeframe for activity.
Addition	Activity End Month	Defined field for respondent to provide timeframe for activity.
Addition	Brief Summary	Defined field for respondent to provide a description of the activity, rather than the previous open-ended field.
Addition	Link to Resources	Defined field for respondent to provide a link to any related resources.
Addition	Collaboration SRP Center	Defined field for respondent to provide information about any collaborations they are participating in.
Addition	Work with Native American Communities	Check box for respondent to indicate if the collaboration includes Native American Communities. (NIEHS is regularly asked to respond to questions about our work with Native American Communities by Congress.)
Addition	Climate Change and/or Disasters	Check box for respondent to indicate if the collaboration involves climate change or disaster research. (NIEHS is regularly asked to respond to questions about our climate change and disaster response by Congress.)
Addition	Work with Environmental Justice	Check box for respondent to indicate if the collaboration involves Environmental Justice research or activities. (NIEHS is regularly asked to respond to questions about Environmental Justice work by Congress.)
No Change	Dataset Title, Accession Number, Dataset URL Link, creator/author, repository name, PMID/DOI

A.16 Plans for Tabulation and Publication and Project Time Schedule

Upon completion of the data analyses, NCI, NICHD, NIDCD, NIEHS, NIMH, and NINDS will prepare technical reports intended for internal audience. If the findings warrant further dissemination, we will publish the results of the various portfolio evaluations in peer-reviewed journals. We do not have a defined time schedule. However, once a research portfolio is identified for an evaluation, we will follow the standard schedule below.

A.16 - 1 Project Time Schedule
Activity	Time Schedule
Identify grantees in the research portfolio	1 week after OMB approval
Invite grantees to participate via email contact, trace and correct email bounce backs	1 month after OMB approval
Monitor web-based and paper based data submissions	2-3 months after OMB approval
Conduct email follow-ups	2-3 months after OMB approval
Data coding, entry, and cleaning	4 months after OMB approval
Data analysis	4 months after OMB approval
Final report	4 months after OMB approval

A.17 Reason(s) Display of OMB Expiration Date is Inappropriate

No exemption from display of expiration date is requested.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions to certification are sought.