The Girl Power Project Efficacy Trial

ICR 201602-0920-008

OMB: 0920-1134

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-02-24
Supplementary Document
2016-02-23
Supplementary Document
2016-02-16
Supplementary Document
2016-02-16
Supplementary Document
2016-02-16
Supplementary Document
2016-02-16
Supporting Statement B
2016-02-16
Supporting Statement A
2016-08-15
ICR Details
0920-1134 201602-0920-008
Historical Active
HHS/CDC 16OJ
The Girl Power Project Efficacy Trial
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 08/15/2016
Retrieve Notice of Action (NOA) 02/24/2016
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
08/31/2017 36 Months From Approved
7,128 0 0
802 0 0
0 0 0

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.

US Code: 3 USC 301 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  80 FR 48534 08/13/2015
81 FR 8962 02/23/2016
Yes

  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
Yes
Miscellaneous Actions
No
This is a NEW collection request for a new OMB Control Number, this is also a one-time information collection request.

$525,937
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Thelma Sims 4046394771

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/24/2016


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