Insurance Coverage, Employment Status, and Copayments/Deductibles Faced by Young Women Diagnosed with Breast Cancer

Forms and Documents

Document Name	Status
Breast Cancer in Young Women screener and survey - survivors from advocacy groups Form	New
Screener for survivors from advocacy groups Form	New
Breast Cancer in Young Women Survey Form and Instruction	New
Attachment 7s - Reminder Letter Spanish_20160628.docx Supplementary Document	2016-07-08
Attachment 7 - Reminder_Letter English 20160628.docx Supplementary Document	2016-07-08
Attachment 5s - Cover Letter Spanish_20160628.docx Supplementary Document	2016-07-08
Attachment 5 - Cover Letter English_20160628.docx Supplementary Document	2016-07-08
Attachment 11 - Letter of Support, NCI.pdf Supplementary Document	2016-02-18
Attachment 10 - RTI IRB Approval Notice.pdf Supplementary Document	2016-02-18
Attachment 9 - RTI Code of Conduct.docx Supplementary Document	2016-02-18
Attachment 8s - Recruitment Flier Spanish.doc Supplementary Document	2016-02-18
Attachment 8 - Recruitment Flier English.doc Supplementary Document	2016-02-18
Attachment 7s - Reminder Letter Spanish.docx Supplementary Document	2016-02-18
Attachment 7 - Reminder_Letter English.docx Supplementary Document	2016-02-18
Attachment 6s - Reminder Postcard Spanish.docx Supplementary Document	2016-02-18
Attachment 6 - Reminder Postcard English_20160212.docx Supplementary Document	2016-02-18
Attachment 5s - Cover Letter Spanish_20160216.docx Supplementary Document	2016-02-18
Attachment 5 - Cover Letter English_20160216.docx Supplementary Document	2016-02-18
Attachment 2 - 60 Day FRN.pdf Supplementary Document	2016-02-18
Attachment 1b - Section 301 of the Public Health Service Act.docx Supplementary Document	2016-02-18
Attachment 1a - EARLY Act of 2009.docx Supplementary Document	2016-02-18
SS Part B_20160205_Rev20160628_markup.docx Supporting Statement B	2016-07-08
SS Part A_20160216_Rev20160628_markup.docx Supporting Statement A	2016-07-08

IC Document Collections

IC ID	Document Title	Status
220163	Breast Cancer in Young Women screener and survey - survivors from advocacy groups Form	New
220162	Screener for survivors from advocacy groups Form	New
220161	Breast Cancer in Young Women Survey Form and Instruction	New

ICR Details

OMB Control No: 0920-1123	ICR Reference No: 201602-0920-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15BDJ
Title: Insurance Coverage, Employment Status, and Copayments/Deductibles Faced by Young Women Diagnosed with Breast Cancer
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: 07/19/2016
	Date Received in OIRA: 02/25/2016
Terms of Clearance: Approved consistent with the understanding that due to the sampling methodology employed in this collection, results will not be generalizable to the national population of breast cancer survivors. Incentives will only be provided to respondents contingent upon return of a completed survey.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	12 Months From Approved
Responses	3,225	0	0
Time Burden (Hours)	1,241	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This study will examine insurance coverage, employment status and out-of-pocket health care expenses among young women diagnosed with breast cancer. Findings may be sued to inform the delivery of breast cancer treatment and reduce barriers to care and services for young, female breast cancer patients. Respondents will be adult women diagnosed with ductal carcinoma in situ or invasive breast cancer.

---

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
   US Code: 42 USC 10413 Name of Law: Education and Awareness Requires Learning Young Act of 2009
  

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 50288	08/19/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 9476	02/25/2016
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Screener for survivors from advocacy groups	none, none	Breast Cancer in Young Women screener ,   Breast Cancer in Young Women screener - Spanish
Breast Cancer in Young Women Survey	none, none, none, none	Breast Cancer in Young Women ,   Breast Cancer in Young Women - Spanish ,   Breast Cancer in Young Women - online survey ,   Breast Cancer in Young Women - Spanish online survey
Breast Cancer in Young Women screener and survey - survivors from advocacy groups	none, none, none, none	Sceener ,   Screener - Spanish ,   Breast Cancer in Young Women Survey ,   Breast Cancer in Young Women Survey - Spanish

---

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	3,225	0	0	3,225	0	0
Annual Time Burden (Hours)	1,241	0	0	1,241	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 ICR.

---

Annual Cost to Federal Government: $743,958

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]? Yes

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: 02/25/2016

---