[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60287-60288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on communication studies 
involving biological products that are regulated by FDA.

DATES: Submit either electronic or written comments on the collection 
of information by December 2, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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. Sec.  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 in-
depth 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 healthcare professional 
decision-making 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

[[Page 60288]]

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.
    FDA estimates the burden of this collection of information based on 
prior experience with the various types of data collection methods 
described above:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                             21 U.S.C.                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Section 393(d)(2)(D)...............................................           9,280                1            9,280           0.2935            2,724
                                                                                                                             (17 min.)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23791 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P