FDA Safety Communication Readership Survey

Forms and Documents

Document Name	Status
0341_SS_Part B_2017.doc Supporting Statement B	2017-07-11
0341_SS_06-12-17.doc Supporting Statement A	2017-06-20

IC Document Collections

IC ID	Document Title	Status
43600	FDA Safety Communication Readership Survey Other-Survey	Modified

ICR Details

OMB Control No: 0910-0341	ICR Reference No: 201706-0910-006
Status: Historical Active	Previous ICR Reference No: 201404-0910-020
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: FDA Safety Communication Readership Survey
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/18/2017
	Date Received in OIRA: 07/12/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	900	0	900
Time Burden (Hours)	153	0	153
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information from health care practitioners and patients. FDA seeks to evaluate the clarity, timeliness, and impact of Safety Communications by surveying a sample of recipients. The information to be collected will address how clearly Safety Communications for reducing risks are explained, the timeliness of the information, and whether the reader has taken any action to eliminate or reduce risk as a result of the information in the Safety Communication. The information will be used to shape FDA's editorial policy for such communications. Understanding how audiences view these publications will aid the Agency in deciding what changes should be considered in their content and format, and method of dissemination.

---

Authorizing Statute(s): US Code: 21 USC 375 (b) Name of Law: null
  

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:
	82 FR 13814	03/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 30870	07/03/2017
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
FDA Safety Communication Readership Survey

---

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	900	900	0	0	0	0
Annual Time Burden (Hours)	153	153	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:

---

Annual Cost to Federal Government: $19,520

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

---

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: 07/12/2017

---