Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 B1- Instrument in English	Form and Instruction	New	Repair queued
SSB_FDA-NCI 9 2 2014.docx	Supporting Statement B	Uploaded 2014-10-16	Repair queued
L - References.docx	Supplementary Document	Uploaded 2014-09-19	Repair queued
J - Letters in English.pdf	Supplementary Document	Uploaded 2014-09-19	Repair queued
K - Letters in Spanish.pdf	Supplementary Document	Uploaded 2014-09-19	Repair queued
H - Westat Confidentiality Pledge.pdf	Supplementary Document	Uploaded 2014-09-19	Repair queued
G - Privacy Act Memo.pdf	Supplementary Document	Uploaded 2014-09-19	Repair queued
F - List of people consulted.docx	Supplementary Document	Uploaded 2014-09-19	Repair queued
E - Comparison of Items.xlsx	Supplementary Document	Uploaded 2014-09-19	Available
D - Privacy Act Assessment.pdf	Supplementary Document	Uploaded 2014-09-19	Repair queued
C - Publications.docx	Supplementary Document	Uploaded 2014-09-19	Repair queued
A - HistoryHints.doc	Supplementary Document	Uploaded 2014-09-19	Repair queued
B2 - Instrument in Spanish.docx	Supplementary Document	Uploaded 2014-09-19	Repair queued
SSA FDA-NCI 9.15.2014.docx	Supporting Statement A	Uploaded 2014-09-15	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
213133	B1- Instrument in English	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201409-0925-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI)
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 10/29/2014
	Date Received in OIRA: 09/23/2014
Terms of Clearance: Withdrawn at the agency's request.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		12 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for OMB to approve a new information collection titled, "Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey." This partnership between NCI and FDA will include assessing the public's knowledge of medical devices, communications related to product recalls, nutritional supplement labeling, and topics to inform FDA's regulatory authority over tobacco, such as risk perceptions about new tobacco products, product pack color gradations, perceptions of product harm, and tobacco product claims and labels. This NCI-FDA survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of FDA-regulated material. This survey will extend the information collected and priorities from the Health Information National Trends Survey (HINTS) which has been to provide a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship.

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Authorizing Statute(s): US Code: 42 USC 285a and 285a-1.1 and 285a-1.3 Name of Law: Public Health Services Act
  

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:
	79 FR 26439	05/08/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 177	09/12/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
B1- Instrument in English	1	Instrument in English

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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: new submisson

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Annual Cost to Federal Government: $1,039,130

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: 09/23/2014

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