Supporting Statement A for
Application for Collaboration with the Therapeutic Development Branch (TDB), Division of Preclinical Innovation (DPI), National Center for Advancing Translational Sciences (NCATS)
March 17, 2015
0925-0658, Expiration Date 06/30/2015--EXTENSION
Name: Nora Yang, Ph.D.
Address: 9800 Medical Center Drive, Building B, Rockville MD, 20850
Telephone: 301-217-1077
Fax: 301-217-5736
Email: TRND@mail.nih.gov
Table of contents
A. JUSTIFICATION
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 Record
keepers
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
List of Attachments:
Attach 1 ( TDB Project Information Template )
Attach 2 ( Online Collaborator Solicitation – TRND )
Attach 3 ( Online Collaborator Solicitation – BrIDGs )
Attach 4 ( Solicitation Instructions – TRND )
Attach 5 ( Solicitation Instructions – BrIDGs )
Attach 6 ( TAG Roster )
Attach 7 ( Altum FAQ )
Attach 8 ( Privacy Memo )
Abstract
This is an extension of a currently approved information collection request. The mission of the National Center for Advancing Translational Sciences (NCATS) is to translate fundamental research into patient treatments by establishing creative partnerships and developing innovative approaches to advance the science of drug discovery and development. The Therapeutic Development Branch (TDB) (1) is an intramural organization, and (2) solicits collaborators in the NIH-novel area of preclinical drug development. The TDB will use the data collected to determine the suitability of Principal Investigators / Research Scientists (applicants) for collaboration with TDB staff and programs.
A.1 Circumstances Making the Collection of Information Necessary
The mission of the National Center for Advancing Translational Sciences (NCATS) is to translate fundamental research into patient treatments by establishing creative partnerships and developing innovative approaches to advance the science of drug discovery and development. The Therapeutic Development Branch (TDB) (1) is an intramural organization, and (2) solicits collaborators in the NIH-novel area of preclinical drug development.
The legal authorities under which the information is requested include: Public Health Service Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part E, Subpart 1, § 287, National Center for Advancing Translational Sciences.
TDB will use the data collected to determine the suitability of the Principal Investigators / Research Scientists (applicants) for collaboration with TDB staff and programs. As the program is resource limited, TDB must select which Principal Investigators / Research Scientists (applicants) offer the best potential for a program to reach the clinic or the patient population. The application forms provide the specific information so that staff and reviewers can evaluate the applicants’ projects. Under the Therapeutics for Rare and Neglected Diseases (TRND) program, successful applicants perform collaborative research with intramural NIH drug development scientists. Under the Bridging Interventional Development Gaps (BrIDGs) program, successful applicants receive access to specific critical resources necessary for the development of therapeutic agents. Applicants would apply to either TRND or BrIDGs, depending upon the resources and scope of assistance needed to advance their particular project. Since 2012, this data collection has enabled the TDB to evaluate approximately 250 proposals, resulting in selection and implementation of 20 highly-meritorious collaborative research and development projects addressing significant unmet medical needs.
The TDB forms are electronic, and are unique to these programs. The online submission ensures no copying or mailing are needed. All correspondence with applicants is managed electronically as well, reducing burden and increasing efficiency of communication. A Privacy Impact Assessment has been completed for this request.
The TDB is a unique program, which currently collects data through the use of these approved, specialized electronic forms. Due to the nature of the drug development projects TDB seeks for partnership, similar information does not exist elsewhere. There will be no unnecessary duplication of information.
TDB programs accept collaboration applications from many partners, including small businesses and other small entities. The design of the TDB form specifically limits data collection to the minimum necessary to make a decision.
Research and development projects in the public and private sector are continually progressing towards stages where they are appropriate for access to TDB resources as part of a collaboration. Currently, TDB is able to undertake annual solicitations for new collaborative partners. This frequency allows TDB programs to offer partners the ability to collaborate and move their projects forward, without an undue waiting period. If this information collection were not conducted, TDB would be unable to assess which potential collaborative projects offer the best potential for a program to reach the clinic or the patient population, and TDB would fail to fulfill its mission of forming novel partnerships that leverage basic research in support of translational science for the benefit of human health.
There are no special circumstances that require collection of information inconsistent with these guidelines. The project forms fully comply with 5 CFR 1320.5.
A 60-Day notice for public comment was published in the Federal Register (Vol. 79, No. 225, Pg. 69499) on November 21, 2014. No public comments were received.
The NCATS Therapeutics for Rare and Neglected Diseases Trans-NIH Advisory Group (TAG) was consulted, and has been actively in discussion since the conception of the program. The role of the TAG (Attach 6) is as follows:
Provide insight and advice on scientific and programmatic issues related to drug discovery and development
Identify areas and projects of common interest for leveraging and prevention of duplication
Help assess potential projects
Help program implementation by providing contacts, identifying collaborators
Receive information and updates from TDB management
This information collection does not provide any payment or gift to respondents.
The NIH Privacy Officer has reviewed the NCATS submission to OMB, which proposes to determine the suitability of Principal Investigators / Research Scientists for collaboration with TDB staff and programs to advance the science of drug discovery (Attach 8).
The Privacy Act will apply to this data collection which involves the collection of personally identifiable information (PII) in the form of client and applicant name, company affiliation, scientific role, e-mail address, phone number, biological/disease expertise, intellectual property (patents issued/pending), bio-sketches, and the actual proposal. This information is needed to contact successful applicants. Selected applications and award data and files will be sent to designated sponsors (e.g., small businesses, entities and partners from the government, non-profit and private grant-making organizations).
The proposals will be collected from applicants and stored in an electronic application, review, and extramural award management system developed under contract by Altum, Inc. The system, called proposalCENTRAL, is a database and e-grantmaking website designed for the benefit of clients (e.g., grantors, grant applicants, and proposal reviewers) to partner drug development scientists with collaborators on therapeutics for rare and neglected diseases. The proposals of the clients, applicants, and awardees will be tracked in the system by ID #. Grant application, review, and award data is maintained on the Altum network and stored in separate databases for each client. Clients will have access to data relevant to the proposals submitted by the client as well as access to applicant profiles relevant to the proposals submitted to the client. A copy of Altum’s security FAQ is located in the attachments (Attach 7).
This data collection is covered by NIH Privacy Act Systems of Record 09-25-0036, “Extramural Awards and Chartered Advisory Committees (IMPAC 2), Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH” (http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm).
There are no sensitive questions included in this collection effort. TDB requests only name and contact information so that successful applicants may be contacted.
12-1. In-house testing was performed by TDB staff to determine the average time required for completing the proposed solicitation. The results of this test indicate an estimated public reporting burden for this collection of information as an average 1 hour per response form. This includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The respondents for all of the surveys are Principal Investigators and Research Scientists.
A.12-1 - Estimates of Hour Burden |
||||
Forms |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Hours Per Response |
Total Annual Burden Hours |
TDB Project Information Template |
170 |
1 |
1 |
170 |
Online Collaborator Solicitation (TRND) |
100 |
1 |
1 |
100 |
Online Collaborator Solicitation (BrIDGs) |
70 |
1 |
1 |
70 |
Solicitation Instructions (TRND) |
100 |
1 |
1 |
100 |
Solicitation Instructions (BrIDGs) |
70 |
1 |
1 |
70 |
Total |
|
|
|
510 |
12-2. The mean hourly wage rate for Medical Scientists (OES code 19-1042) is estimated as $43.38, obtained from the May 2013 Department of Labor Occupational Employment Statistics program (http://www.bls.gov/oes/current/oes191042.htm). The annualized cost burden based on the respondents’ time to complete the submission process is estimated to be $22,125.
A.12-2 - Annualized Cost to Respondents |
|||
Forms |
Total Annual Burden Hours |
Hourly Wage Rate |
Total Annual Response Cost |
TDB Project Information Template |
170 |
$43.38 |
$7,375 |
Online Collaborator Solicitation (TRND) |
100 |
$43.38 |
$4,338 |
Online Collaborator Solicitation (BrIDGs) |
70 |
$43.38 |
$3,037 |
Solicitation Instructions (TRND) |
100 |
$43.38 |
$4,338 |
Solicitation Instructions (BrIDGs) |
70 |
$43.38 |
$3,037 |
TOTAL |
|
|
$22,125 |
There are no additional costs other than the respondent’s time.
This data collection is estimated to cost the Federal Government $24,890 annualized.
A.14 - Annualized Cost to the Federal Government |
|
|
Total Cost
|
Annual Cost for Use of Altum / proposalCENTRAL System
|
$15,000 |
NCATS Project Manager, GS 13-4 (10% effort) |
$9,890 |
TOTAL |
$24,890 |
This is an ongoing collection of information, already in OMB’s inventory of approved projects. There are no program changes or adjustments to the annual burden on respondents.
TDB application data is collected for internal review only. There are no plans for publication of any statistical analyses based on the information collected and applications are not published.
The expiration date for OMB approval will be displayed.
No exceptions to the certification are requested.
B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS
This collection does not employ statistical methods.
| File Type | application/msword |
| File Title | Supporting Statement 'A' Preparation - 04/05/2011 |
| Subject | Supporting Statement 'A' Preparation - 04/05/2011 |
| Author | OD/USER |
| Last Modified By | Currie, Mikia (NIH/OD) [E] |
| File Modified | 2015-03-18 |
| File Created | 2015-03-18 |