Case Investigation of Cervical Cancer (CICC) Study

Forms and Documents

Document Name	Status
Support for Medical Record Abstraction Form	New
Medical Release and Healthcare Source Forms Form	New
Case Investigation of Cervical Cancer Study Survey Form	New
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	New
221994	Medical Release and Healthcare Source Forms Form	New
221992	Case Investigation of Cervical Cancer Study Survey Form	New

ICR Details

OMB Control No: 0920-1162	ICR Reference No: 201606-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16UW
Title: Case Investigation of Cervical Cancer (CICC) Study
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: 02/06/2017
	Date Received in OIRA: 06/22/2016
Terms of Clearance: 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	24 Months From Approved
Responses	1,754	0	0
Time Burden (Hours)	217	0	0
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
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
Case Investigation of Cervical Cancer Study Survey	none, none	Case Investigation of Cervical Cancer ,   Case Investigation of Cervical Cancer - Spanish

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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	0	0	1,754	0	0
Annual Time Burden (Hours)	217	0	0	217	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. 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

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

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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: 06/22/2016

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