Document ID: FDA-2013-N-1164-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Testing
Communications on Biological Products
Posted Date: 2014-06-09T04:00Z

[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32963-32964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1164]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Testing 
Communications on Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 9, 
2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0687. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Testing Communications on Biological Products--(OMB Control Number 
0910-0687)--Extension

    FDA is authorized by section 1003(d)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational 
and public information programs relating to the safety of regulated 
biological products. FDA conducts needed research to help ensure that 
such programs have the highest likelihood of being effective. FDA 
expects that improving communications about biological products will 
involve many research methods, including individual indepth interviews, 
mall-intercept interviews, focus groups, self-administered surveys, 
gatekeeper reviews, and omnibus telephone surveys. The information will 
be used to explore concepts of interest and assist in the development 
and modification of communication messages and campaigns to fulfill the 
Agency's mission to protect the public health.
    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. Knowledge of consumer and health care professional 
decisionmaking processes will provide the better understanding of 
target audiences that FDA needs to design effective communication 
strategies, messages, and labels. These communications will aim to 
improve public understanding of the risks and benefits of using 
biological products by providing users with a better context in which 
to place risk information more completely.
    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. Testing 
messages with a sample of the target audience will allow FDA to refine 
messages while still in the developmental stage. Respondents will be 
asked to give their reaction to the messages in either individual or 
group settings.
    Third, as evaluative research, it will allow FDA to ascertain the 
effectiveness of the messages and the distribution method of these 
messages in achieving the objectives of the message campaign. 
Evaluation of campaigns is a vital link in continuous improvement of 
communications at FDA.
    In the Federal Register of October 1, 2013 (78 FR 60287), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information based on 
prior experience with the various types of data collection methods 
described in this document:

[[Page 32964]]

                                   Table 1--Estimated Annual Reporting Burden
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21 U.S.C. Section 393(d)(2)(D)                     Number of
   (various data collection        Number of     responses per   Total annual    Average burden     Total hours
           methods)               respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Individual Indepth Interviews.             360               1             360  0.75 (45                     270
                                                                                 minutes).
General Public Focus Group                 288               1             288  1.50 (90                     432
 Interviews.                                                                     minutes).
Intercept Interviews: Central              200               1             200  0.25 (15                      50
 Location.                                                                       minutes).
Intercept Interviews:                    4,000               1           4,000  0.08 (5 minutes)             320
 Telephone.
Self-Administered Surveys.....           2,400               1           2,400  0.25 (15                     600
                                                                                 minutes).
Gatekeeper Reviews............             400               1             400  0.50 (30                     200
                                                                                 minutes).
Omnibus Surveys...............           1,200               1           1,200  0.17 (10                     204
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total (General Public)....           8,848               1           8,848  ................           2,076
Physician Focus Group                      432               1             432  1.50 (90                     648
 Interviews.                                                                     minutes).
                               ---------------------------------------------------------------------------------
    Total (Physician).........             432  ..............  ..............  ................             648
    Total (Overall)...........           9,280               1           9,280  0.29 (17                   2,724
                                                                                 minutes).
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    Dated: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13292 Filed 6-6-14; 8:45 am]
BILLING CODE 4160-01-P