Case Investigation of Cervical Cancer (CICC) Study

Forms and Documents

Document Name	Status
Support for Medical Record Abstraction Form	Unchanged
Medical Release and Healthcare Source Forms Form	Unchanged
Case Investigation of Cervical Cancer Study Survey Form	Unchanged
OMB Change for 0920-1162 (CICC study) AG Request #1 only revised_clean.docx Justification for No Material/Nonsubstantive Change	2018-02-28
Attachment 10 IRB Approval Letters.pdf Supplementary Document	2017-02-06
Attachment 10. Battelle IRB Approval Letter.pdf Supplementary Document	2016-06-15
Attachment 8b. CICC Phonescript Follow-up to Mailing Spanish.doc Supplementary Document	2016-06-15
Attachment 8a. Phone Follow-up Script English.doc Supplementary Document	2016-06-15
Attachment 6b. CICC Research participant information sheet Spanish 2016 06 10.docx Supplementary Document	2016-06-15
Attachment 6a. CICC Research participant information sheet English 2016 06 10.docx Supplementary Document	2016-06-15
Attachment 5b. CICC Cover letter Spanish 2016 06 10.docx Supplementary Document	2016-06-15
Attachment 5a. CICC Cover letter English 2016 06 10.docx Supplementary Document	2016-06-15
Attachment 3. Letter to physicians 2016 06 10.docx Supplementary Document	2016-06-15
Attachment 2. 60-Day FRN.docx Supplementary Document	2016-06-15
Attachment 1. Section 301 of the Public Health Service Act.docx Supplementary Document	2016-06-15
CICC_SS Part B_2016 06 10_OMB clean.docx Supporting Statement B	2017-02-06
CICC_SS Part A_2016 06 10_OMB clean.docx Supporting Statement A	2017-02-06

IC Document Collections

IC ID	Document Title	Status
221997	Support for Medical Record Abstraction Form	Unchanged
221994	Medical Release and Healthcare Source Forms Form	Unchanged
221992	Case Investigation of Cervical Cancer Study Survey Form	Unchanged

ICR Details

OMB Control No: 0920-1162	ICR Reference No: 201802-0920-012
Status: Historical Active	Previous ICR Reference No: 201606-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18TG
Title: Case Investigation of Cervical Cancer (CICC) Study
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/12/2018
	Date Received in OIRA: 02/28/2018
Terms of Clearance: As approved in this change request, CDC will permit allowing cancer registries to send the $25 approved incentive in two payments: a $5 gift card enclosed insider the mailer to non-respondents, followed by the $20 incentive for completion of the survey. CDC will evaluate and share any outcomes from this collection related to incentives that may be helpful to the broader Federal community concerning incentive design and characteristics of respondents. Previous terms continue: Approved consistent with the understanding that due to the sampling frame employed in this collection, which collects data from cancer survivors in only three state cancer registries, outcomes may not be representative of the entire population of women diagnosed with cervical cancer in the United States and are thus not intended to be generalized to broader populations. Any limitations posed by the sampling methodology and frame employed in this study with regard to the non-generalizability of the data to broader populations will be clearly described in any presentations, publications, or communications associated with this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	02/28/2019	02/28/2019
Responses	1,754	0	1,754
Time Burden (Hours)	217	0	217
Cost Burden (Dollars)	0	0	0

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Abstract: Although the incidence and severity of cervical cancer can be significantly reduced through prevention and early detection strategies, many women do not receive the appropriate vaccination and screening services. CDC is conducting a study to improve understanding of the barriers to cervical cancer screening and follow-up care. Information will be collected through self-administered surveys and medical chart reviews.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 15724	03/24/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 40702	06/22/2016
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Case Investigation of Cervical Cancer Study Survey	none, none	Case Investigation of Cervical Cancer ,   Case Investigation of Cervical Cancer - Spanish
Medical Release and Healthcare Source Forms	none, none	Medical Release and Healthcare Source Form - English ,   Medical Release and Healthcare Source Form - Spanish
Support for Medical Record Abstraction	none	Medical Record Abstraction

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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	1,754	1,754	0	0	0	0
Annual Time Burden (Hours)	217	217	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: This is a new ICR. Burden total is off by 1 due to rounding.

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Annual Cost to Federal Government: $432,899

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

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Common Form ICR:  No

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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: 02/28/2018

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