[Federal Register: July 13, 2010 (Volume 75, Number 133)]


[Page 39952-39953]

From the Federal Register Online via GPO Access []




Food and Drug Administration

[Docket No. FDA-2010-N-0344]

Agency Information Collection Activities; Proposed Collection;

Comment Request; Testing Communications on Medical Devices and

Radiation-Emitting Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 and

to allow 60 days for public comment in response to the notice. This

notice solicits comments on communication studies involving medical

devices and radiation-emitting products regulated by FDA. This

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.

DATES: Submit either electronic or written comments on the collection

of information by September 13, 2010.

ADDRESSES: Submit electronic comments on the collection of information

to 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.


Information Management, Food and Drug Administration, 1350 Piccard Dr.,

PI50-400B, Rockville, MD 20850, 301-796-5156,

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 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.

Page 39953

Testing Communications on Medical Devices and Radiation-Emitting

Products--(OMB Control Number 0910-New)

FDA is authorized by section 1003(d)(2)(D) of the Federal Food,

Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(D)) to conduct

educational and public information programs relating to the safety of

regulated medical devices and radiation-emitting products. FDA must

conduct needed research to ensure that such programs have the highest

likelihood of being effective. Improving communications about medical

devices and radiation-emitting 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 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 medical device

and radiation-emitting 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 medical devices and radiation-emitting products by providing

users with a better context in which to place risk information more


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.

FDA estimates the burden of this collection of information as


Table 1.--Estimated Annual Reporting Burden


Total Operating &

Section of the act No. of Annual Frequency Total Annual Hours per Total Hours Maintenance

Respondents per Response Responses Response Costs\1\


1003(d)(2)(D) 16,448 1 16,448 0.1739 2,860 $25,239


Total 16,448 1 16,448 0.1739 2,860 $25,239


\1\ There are no capital costs associated with this collection of information.

Annually, FDA projects about 30 studies using a variety of research

methods, and lasting an average of 0.17 hours each (varying from 0.08-

1.5 hours). The operating and maintenance costs include contractor

expenses for designing and conducting information collection

activities, specifically, drawing samples, training interviewers,

collecting and analyzing information, and reporting and disseminating

findings. FDA estimates the burden of this collection of information

based on prior recent experience with the various types of data

collection methods described earlier. FDA is requesting this burden so

as not to restrict the agency's ability to gather information on public

sentiment for its proposals in its regulatory and communications


Dated: July 7, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-16973 Filed 7-12-10; 8:45 am]