Testing Communications on Biological Products

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
FDA CBER Abbreviated SS.doc	Supplementary Document	Uploaded 2011-05-31	Available
SUPPORTING STATEMENT PART B 0687 5-22-14.doc	Supporting Statement B	Uploaded 2014-05-22	Available
SUPPORTING STATEMENT PART A 0687 FINAL 5-22-14.doc	Supporting Statement A	Uploaded 2014-06-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
211878	Physician Focus Group Interviews		New
211698	Omnibus Surveys		New
211697	Gatekeeper Reviews		New
211695	Self-Administered Surveys		New
211694	Intercept Interviews: Telephone		New
211693	Intercept Interviews: Central Location		New
211692	General Public Focus Group Interviews		New
211691	Individual In-Depth Interviews		New

ICR Details

OMB Control No: 0910-0687	ICR Reference No: 201405-0910-019
Status: Historical Active	Previous ICR Reference No: 201102-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Testing Communications on Biological Products
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: 08/21/2014
	Date Received in OIRA: 06/18/2014
Terms of Clearance: This generic clearance for FDA/CBER is approved for 3 years under the following conditions: (1) For individual "tests," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, justification for any proposed incentive, and estimated burden); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	9,280	0	9,280
Time Burden (Hours)	2,724	0	2,724
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA plans to use the data collected under this generic clearance to inform its biological product communications campaigns. FDA expects data to guide the formulation of its communication objectives on biological products. FDA also plans to use the data to help tailor print, broadcast, and electronic media communications in order for them to have powerful and desired impacts on target audiences. The data will not be used for the purposes of making policy or regulatory decisions. The information collected will serve three major purposes. First, as formative research it will provide critical knowledge needed about target audiences to develop messages and campaigns about biological product use. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Third, as evaluative research it will allow FDA to ascertain the effectiveness of the message and the distribution of method of these messages in achieving the objectives of the message campaign. Data collected under this generic clearance will also help inform the FDA's newly established Risk Communication Advisory Committee and would constitute a further effort to respond to the Institute of Medicine's recommendation in its September 2006 report The Future of Drug Safety that FDA improve its communications with the public.

---

Authorizing Statute(s): US Code: 21 USC 1003(d)(2)(D) Name of Law: FFDCA
   US Code: 21 USC 393(d)(2)(D) Name of Law: FFDCA
   US Code: 21 USC 702 Name of Law: FFDCA
   US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	78 FR 60287	10/01/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 32963	06/09/2014
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 8

table that charts list of burden

IC Title	Form No.	Form Name
Self-Administered Surveys
Physician Focus Group Interviews
Individual In-Depth Interviews
Intercept Interviews: Central Location
General Public Focus Group Interviews
Gatekeeper Reviews
Intercept Interviews: Telephone
Omnibus Surveys

---

ICR Summary of Burden

table that charts list 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	9,280	9,280	0	0	0	0
Annual Time Burden (Hours)	2,724	2,724	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: $1,674,708

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

---

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: 06/18/2014

---