Document ID: FDA-2010-N-0464-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Testing Communications on Biological Products
Posted Date: 2011-01-28T05:00Z

[Federal Register Volume 76, Number 19 (Friday, January 28, 2011)]
[Notices]
[Pages 5179-5180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1862]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0464]

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 
February 28, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--New and 
title ``Testing Communications on Biological Products.'' Also include 
the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@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--New)

    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)) (Attachment 2) to conduct 
educational and public information programs relating to the safety of 
regulated biological products. FDA must conduct needed research to 
ensure that such programs have the highest likelihood of being 
effective. FDA expects that improving communications about biological 
products including

[[Page 5180]]

vaccines and blood products will involve many research methods, 
including individual in-depth interviews, mall-intercept interviews, 
focus groups, self-administered surveys, gatekeeper reviews, and 
omnibus telephone surveys.
    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 healthcare 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 including vaccines and blood 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 5, 2010 (75 FR 61492), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR Section              Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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1003(d)(2)(D)...................          16,448               1          16,448          0.1739           2,860
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    Total.......................  ..............  ..............  ..............  ..............           2,860
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: January 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1862 Filed 1-27-11; 8:45 am]
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