Supporting Statement A For:
Using Public Data for Cancer Prevention and Control:
From Innovation to Impact (NCI)
June 29, 2011
Abdul R Shaikh, PhD, MHSc,
Program Director
Health Communication and Informatics Research Branch,
Behavioral Research Program,
Division of Cancer Control and Population Science (DCCPS)
National Cancer Institute
6130 Executive Blvd / EPN 4062
Bethesda, MD 20892-7335
Phone: 301-594-6690
Fax: 301-435-7547
E-mail: [email protected]
Table of Contents
A. Justification 1
A.1 Circumstances Making the Collection of Information Necessary 1
A.2. Purpose and Use of the Information Collection 2
A.3 Use of Improved Information Technology and Burden Reduction 4
A.4 Efforts to Identify Duplication and Use of Similar Information 4
A.5 Impact on Small Businesses or Other Small Entities 4
A.6 Consequences of Collecting the Information Less Frequently 5
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 5
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 5
A.9 Explanation of Any Payment or Gift to Respondents 6
A.10 Assurance of Confidentiality Provided to Respondents 7
A.11 Justification for Sensitive Questions 8
A.12 Estimates of Annualized Burden Hours And Costs 8
A.13 Estimates of Other Total Annual Cost Burden to Respondents and
Record Keepers 9
A.14 Annualized Cost to the Federal Government 9
A.15 Explanation for Program Changes or Adjustments 10
A.16 Plans for Tabulation and Publication and Project Time Schedule 10
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate 12
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 12
List of Attachments
Attachment 1: Judging Criteria
Attachment 2: OFFICIAL RULES FOR CHALLENGE CONTEST
ATTACHMENT 3: SUBMISSION APPLICATION
Attachment 4: SUBMISSION REQUIREMENTS
Attachment 5: PIA & privacy act Email
ATTACHMENT 6: Challenge.gov Privacy & PIA guidance
A.1 Circumstances Making the Collection of Information Necessary
This contest addresses the National Cancer Institute (NCI) Division of Cancer Control and Population Science (DCCPS) mission to reduce the risk, incidence, and deaths from cancer as well as enhance the quality of life for cancer survivors. NCI, part of the National Institutes of Health (NIH), was established by Congress in 1937 and is the leading Federal agency and the world’s largest organization solely dedicated to cancer-related research (including health communication and informatics), training, and dissemination of information.
The Public Health Service Act, Section 412 (42 USC § 285a-1) authorizes the DCCPS of the NCI to establish and support programs that demonstrate “new methods for the dissemination of information to the general public concerning prevention, early detection, diagnosis, and treatment and control of cancer.”
The Division of Cancer Control and Population Sciences is announcing the launch of the Using Public Data for Cancer Prevention and Control: From Innovation to Impact Developer Challenge. Contestants are asked to develop software applications (apps) that utilize the wide array of health-related data made available by the NCI DCCPS and other Federal agencies for innovative consumer health apps; these apps should potentially integrate with existing technology platforms and address targets comprising DCCPS priority areas on the continuum of cancer prevention and control: http://cancercontrol.cancer.gov/od/index.html. Contestants are required to address challenges faced by consumers, clinicians, or researchers such as behavior risk reduction for prevention/survivorship (e.g., nutrition, physical activity, smoking cessation), early detection and screening, informed decision-making, and adherence to treatment regimens.
This Challenge effort is also aligned with the Whitehouse Open Government Initiative (http://www.whitehouse.gov/open), the America COMPETES Act (http://www.whitehouse.gov/blog/2011/01/06/america-competes-act-keeps-americas-leadership-target), and the HHS Community Health Data Initiative (http://www.hhs.gov/open/datasets/about.html). This initiative utilizes the new prize authority in the America COMPETES Act to address the President’s call for agencies to increase their use of prizes and challenges to spur innovation and solve difficult problems.
A.2 Purpose and Use of the Information
The National Cancer Institute’s (NCI) “Using Public Data for Cancer Prevention and Control: From Innovation to Impact” Challenge is a contest aimed at encouraging multidisciplinary teams of software developers, entrepreneurs, and health scientists to utilize the wide array of health-related data made available by NCI’s Division of Cancer Control and Population Sciences (DCCPS) and other Federal agencies for innovative consumer health applications (apps). This Challenge builds on a previous Challenge released by the NCI in 2010 that resulted in five contestants. Each entry will be rated on the strength of its potential to help consumers, clinicians, and/or researchers address challenges related to the continuum of cancer prevention and control. The panel of judges will assess entries based on factors including innovation, usability, and potential impact on cancer prevention and control. See Attachment 1 for more details about judging criteria.
Suggested targets comprise behavior risk reduction for prevention/survivorship (e.g., nutrition, physical activity, smoking cessation), early detection and screening, informed decision-making, and adherence to treatment regimens. Examples include, but are not limited to, apps that provide new ways of visualizing and communicating complex health information for risk communication; consumer decision support incorporating multiple sources of data to reduce the burden of cancer and enhance outcomes following diagnosis and treatment; and decision aides for cancer screening (e.g., PSA, breast, and cervical cancer).
Contestants can read the Official Rules and Eligibility (Attachment 2) posted on Challenges.gov and register at the Health 2.0 Developer Challenge portal: http://www.health2challenge.org/. Registration is free and can be completed anytime during the Phase I App Submission Period, July 1 to August 15th, 2011. Submissions should include the contestant’s contact information, title, description, and link to the app, and a list of data sources and/or datasets used (Attachment 3).
Submission requirements include specifics about acceptable platforms, data used, accessibility, intellectual property, functionality/accuracy, and security (see Attachment 4 for more details). NCI will also screen submissions for eligibility of the submitting Contestant and compliance with the Standards of Conduct for Federally sponsored Challenges authorized by the America COMPETES Reauthorization Act for 2010 (Public L. No 111-358).
Up to four finalist teams in Phase I will each receive a $10,000 award in conjunction with their participation in a special session in September 2011 in San Francisco coinciding with the Health 2.0 Fall Conference. The purpose of this session is to present to and engage with leaders in government, venture capital, and technology for support in translating innovations into commercially successful apps with potential public health impact.
At the culmination of Phase II, up to two winning teams selected from the slate of Phase I finalists will each receive a $20,000 award in a special symposium on January 4th, 2012 at the January 2012 Hawaii International Conference on Systems Science (HICSS). The HICSS symposium will focus on linking application developers with experts in the health science, commercial and venture capital arenas for tailored advice on commercialization, integration with existing platforms, and public health impact. Winning teams and finalists who meet the requisite qualifications, will also be encouraged to apply for relevant funding opportunities to further develop and commercialize their innovative apps for cancer prevention and control in NCI’s Small Business Innovation Research (SBIR) program: http://sbir.cancer.gov/.
All communication with challenge contestants, including registration and notification of finalists will be conducted electronically, either online, or by email. If contestants are unable to be contacted by email, they have the option of telephone or mail contact.
See Attachment 5 for review and confirmation by the NIH Privacy Act Officer (Karen Pla) and NCI Privacy Act Coordinator (Suzanne Milliard) that a Privacy Impact Assessment (PIA) is not needed because the GSA has already completed a PIA that extends to all agencies’ use (Attachment 6).
Though other agencies may put out challenges (such as the FDA), no other cancer-related challenges are being developed by the Federal Government.
It is anticipated that primarily individuals will apply to this challenge, but it is not unlikely that small software-related businesses may also apply. Due to the nature of the challenge and based on the principles of crowdsourcing and innovation (http://en.wikipedia.org/wiki/Crowdsourcing), there are no inherent barriers for small businesses that wish to participate.
Contestants will be submitting one entry for Phase I of the challenge between July 1st, 2011 and August 15th, 2011. Up to four finalists will be asked to submit a revised entry for Phase II of the challenge between October 3rd, 2011, and November 18th 2011.
No special circumstances are anticipated. All guidelines of 5 CFR 1320.5 have been met.
OMB has approved emergency processing of this submission and has also waived the publication of the 60 and 30-day Federal Register notices. Future submissions related to this will be processed in a timely manner through a generic clearance, as needed.
The project team leading this effort is comprised of staff including: Abdul R. Shaikh (NCI), Bradford Hesse (Branch Chief, NCI), and Gordon Willis (NCI), in consultation with Wil Yu (Special Assistant, ONC) and Greg Downing (HHS Office of the Secretary). Contact information is listed in the table below.
Bradford Hesse, Branch Chief, Health Comm and Informatics Branch, NCI |
[email protected]; 301 594 9904 |
Gordon Willis |
[email protected]; 301 594 6652 |
Wil Yu, Special Assistant, Office of the National Coordinator (ONC) |
[email protected]; 202 690 5920 |
Greg Downing, Office of the Secretary, HHS |
[email protected]; 202 260 1911
|
Up to four finalist teams in Phase I will each receive a $10,000 award in conjunction with their participation in a special session in September 2011 in San Francisco coinciding with the Health 2.0 Fall Conference. At the culmination of Phase II, up to two winning teams selected from the slate of Phase I finalists will each receive a $20,000 award in a special symposium on January 4th, 2012 at the January 2012 Hawaii International Conference on Systems Science (HICSS). Winning teams and finalists who meet the requisite qualifications, will also be encouraged to apply for relevant funding opportunities to further develop and commercialize their innovative apps for cancer prevention and control in NCI’s Small Business Innovation Research (SBIR) program: http://sbir.cancer.gov/.
This initiative utilizes the new prize authority in the America COMPETES Act by using the aforementioned prizes to help spur innovative solutions for cancer prevention and control by remunerating winning contestants for the time and effort expended in developing leading-edge software applications for the challenge. It is estimated that it would take at least 200 hours of development and graphic design (not including usability testing and systems integration) effort for mobile applications at $50/hr to equal $10,000 in cost. Typically, the development of sophisticated software applications addressing challenges faced by consumers, clinicians, and researchers such as behavior risk reduction for prevention (e.g., nutrition, physical activity, smoking cessation), and adherence to treatment regimens would cost significantly more to develop and implement.
NCI will also screen submissions for eligibility of the submitting Contestant and compliance with the Standards of Conduct for Federally sponsored Challenges authorized by the America COMPETES Reauthorization Act for 2010 (Public L. No 111-358). By submitting the entries, contestants consent to IT security testing and debarment and compliance screening. Submissions satisfying these criteria will be deemed eligible and posted on the Health 2.0 Developer Challenge portal (http://www.health2challenge.org/) on a rolling basis.
In addition to complying with appropriate policies, procedures and protections for data that ensures all privacy requirements, intellectual property considerations, and institutional/sponsor restrictions are met, use of publically available data obtained from NCI and other Federal partners should not allow the identification of an individual human subject from whom NCI and other Federal partners obtained such data.
If contestants choose to provide the NCI with personal information by registering or filling out the submission form through the Challenge website (http://www.health2challenge.org/), that information will be used to respond to them in matters regarding their submission, announcements, and winners of the Challenge, related to promotion of the Challenge -- unless they choose to receive updates or notifications about other competitions from the NCI on an opt-in basis. Information is not collected for commercial marketing. Winners are permitted to cite that they won the contest.
The challenge administration contractor will be collecting personally identifiable information (PII) in the form of the contestant’s name, email address, telephone number, social security number, and mailing address. Social security numbers are collected to facilitate distribution of prizes to finalists and winners. NCI will, as necessary, be provided with contestant’s names, email addresses, and telephones for communication regarding the challenge.is not available to the U.S. Governmehallenge.gov is not a Privacy Act System of Record and does not require a SORN.
a. Annual Burden Hours. Table A.12-1 describes the estimates of the contestant’s burden for participation in the challenge. The time for the contestant to complete the entry form is approximately 30 minutes. The total annual burden is estimated to be 12 hours.
Table A.12-1: Estimates of Annual Burden Hours |
||||
Type of Respondents |
Number of Respondents |
Frequency of Response |
Average Time per Response (Hours) |
Annual Hour Burden |
Contestants |
20 |
1 |
30/60 |
10 |
Finalists |
4 |
1 |
30/60 |
2 |
Totals |
24 |
|
|
12 |
Annualized Costs to Contestants. At $50.00 per hour, the total estimated annualized cost to contestants is $600 (Table A.12-2).
Table A.12-2: Annualized Cost to Contestants |
|||||
Type of Respondents |
Number of Respondents |
Frequency of Response |
Average Time per Response (Hours) |
Hourly Wage Rate |
Total Respondent Cost |
Contestants |
20 |
1 |
30/60 |
$50.00 |
$500 |
Finalists |
4 |
1 |
30/60 |
$50.00 |
$100 |
Totals |
24 |
|
|
|
$600 |
There are no capital costs, operating costs, or maintenance costs to report.
The estimated total cost to the government for the services of the challenge contractor over the duration of the challenge (i.e., 6 months) is $20,000. This amounts to an annualized cost of $40,000. These costs include running the challenge registration platform, regular updates, interaction with contestants, judging management, and promotional activities.
NCI staff time required to participate in planning the challenge, participating in judging and award-related activities is estimated to average .05 FTE for scientific staff over the 12-month study period. These figures correspond to an estimated annualized cost of $5,000. The total annualized cost to the government is estimated to be $45,000.
The overall government distribution is summarized in the following table:
Table A.14-1 Government Cost Distribution
|
6 Month Challenge Period |
ANNUAL AVERAGE |
Contractor Costs |
$20,000 |
$40,000 |
NCI Personnel Subtotal |
$2,500 |
$5,000 |
Grand Total |
$22,500 |
$45,000 |
Thus, average annual cost to the government over the 12-month period is approximately $45,000.
This is a new collection of information that is being submitted for emergency processing based on the need to have approval in a short time frame.
This is a contest and thus there is no tabulation or analysis involved. Table A.16-1 outlines the project time schedule and steps.
Table A.16-1. Project Time Schedule |
|
Phase I: |
|
Submission Period Begins |
12:01am, EDT, July 1st, 2011 |
Submission Period for Initial Entries Ends |
11:59 pm, EDT, August 15th, 2011 |
Judging Process for Finalists Begins |
12:01am, EDT, August 16th, 2011 |
Judging Process for Finalists Ends |
11:59pm, EDT, August 19th, 2011 |
Finalist(s) notified |
August 22nd, 2011 |
Finalist Demos at Health 2.0 Conference |
September 25-27, 2011 |
Phase II: |
|
Final Submission Period Begins |
12:01am, EDT, October 3rd, 2011 |
Final Submission Period Ends |
11:59pm, EST, November 18th, 2011 |
Final Judging Process Begins |
12:01am, EST, November 19th, 2011 |
Final Judging Process Ends |
11:59pm, EST, November 25th, 2011 |
Winner(s) notified |
November 30th, 2011 |
Award Presentation at HICSS Symposium |
January 4th, 2012 |
Upon submission, each contestant warrants that he or she is the sole author and owner of the submission, that the submission is wholly original with the contestant (or is an improved version of an existing app that the contestant has sufficient rights to use – including the substantial improvement of existing open-source apps), and that it does not infringe any copyright or any other rights of any third party of which contestant is aware. Each contestant also warrants that the app is free of malware.
The Phase I finalists will be notified by email, telephone, or mail after the date of the judging. The Finalists (or Finalist’s parent/guardian if under 18 years of age) and Challenge Winner (or Challenge Winner’s parent/guardian if under 18 years of age), will be required to sign and return to NCI, within ten (10) days of the date notice being sent, an Affidavit of Eligibility and Liability/Publicity Release (except where prohibited) in order to claim any recognition.
Each contestant grants to the NCI an irrevocable, paid-up, royalty-free non-exclusive worldwide license to post, link to, share, and display publicly the app on the Web, for the purpose of the Challenge, during the duration of the Challenge and for a period of one year following announcement of the winner. All contestants will retain all other intellectual property rights over their submissions.
All instruments will display the OMB expiration date.
No exceptions to the Certification for Paperwork Reduction Act Submissions are requested.
| File Type | application/msword |
| File Title | PLCO SCREENING TRIAL |
| Author | Linda Suit |
| Last Modified By | Lisa |
| File Modified | 2011-06-29 |
| File Created | 2011-06-29 |