The Girl Power Project Efficacy Trial

Forms and Documents

Document Name	Status
Att 2c - Response to Public Comment.docx Supplementary Document	2016-02-24
30dy FRN published.pdf Supplementary Document	2016-02-23
Att 13 Recruitment Ads Script.pdf Supplementary Document	2016-02-16
Att 12 IRB approval letter 1510060mod.pdf Supplementary Document	2016-02-16
Att 2a 60-Day FRN.pdf Supplementary Document	2016-02-16
Att 1 Authorizing Legislation.pdf Supplementary Document	2016-02-16
SS B_2 05 2016.docx Supporting Statement B	2016-02-16
Crush App_SS A_2 05 2016_OMB 8 15 2016_clean.docx Supporting Statement A	2016-08-15

IC Document Collections

IC ID	Document Title	Status
220120	Att 9_6-Month Survey (Control) Other-Screenshots	New
220119	Att 8_6-Month Survey (Intervention) Other-Screenshots	New
220118	Att 7_3-Month Survey (Control) Other-Screenshot	New
220117	Att 6_3-Month Survey (Intervention) Other-Screenshots	New
220116	Att 5_Baseline Survey (Control) Other-Screenshots	New
220115	Att 4_Baseline Survey (Intervention) Other-Screenshots	New
220113	Att 3b_Enrollment Other-Screenshots	New
220112	Att 3a_Screener Questions Other-Screenshots	New

ICR Details

OMB Control No: 0920-1134	ICR Reference No: 201602-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16OJ
Title: The Girl Power Project Efficacy Trial
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/15/2016
	Date Received in OIRA: 02/24/2016
Terms of Clearance: Approved consistent with the understanding that the waiver of parental consent for the participation of youth under the age of 18 has been specifically reviewed and approved by the Institutional Review Board. All communications of outcomes from this study will convey that this short-term project is not sufficiently powered or designed to evaluate the effect of the Crush app on teen pregnancy outcomes---but rather to assess for potential changes in self-reported use of contraception and clinic utilization 3 months and 6 months after initial use of the mobile application. In addition, the study cannot distinguish dosage effects associated with variable rates of use of the application on measured outcomes due to insufficient sample size. Any reports, presentations, or publications describing the outcomes of this study will clearly communicate the above limitations inherent to the study's sample size and design.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved
Responses	7,128	0	0
Time Burden (Hours)	802	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: CDC plans to test the efficacy of a comprehensive and medically accurate mobile (smartphone) application in increasing adolescent girls' contraception use and clinic visitation for sexual and reproductive health services. Participants will be assigned to a Control group or an intervention group. Information will be collected at baseline, and at three and six month followups.

---

Authorizing Statute(s): US Code: 3 USC 301 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 48534	08/13/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 8962	02/23/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Att 6_3-Month Survey (Intervention)
Att 7_3-Month Survey (Control)
Att 8_6-Month Survey (Intervention)
Att 3a_Screener Questions
Att 3b_Enrollment
Att 4_Baseline Survey (Intervention)
Att 5_Baseline Survey (Control)
Att 9_6-Month Survey (Control)

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	7,128	0	0	7,128	0	0
Annual Time Burden (Hours)	802	0	0	802	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a NEW collection request for a new OMB Control Number, this is also a one-time information collection request.

---

Annual Cost to Federal Government: $525,937

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/24/2016

---