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Food and Drug Administration, HHS.
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.
Fax written comments on the collection of information by March 11, 2020.
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 firstname.lastname@example.org. All comments should be identified with the OMB control number 0910-0678. Also include the FDA docket number found in brackets in the heading of this document.
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FOR FURTHER INFORMATION CONTACT:
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov.
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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 Medical Devices and Radiation-Emitting Products
OMB Control Number 0910-0678—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 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 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 medical devices and radiation-emitting 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.
Annually, FDA projects conducting about 30 studies using a variety of research methods and lasting an average of 0.17 hours each (varying from 0.08 to 1.5 hours). FDA estimates the burden of this collection of information based on prior 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 programs.
In the Federal Register of November 15, 2019 (84 FR 62541), 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 as follows:
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Table 1—Estimated Annual Reporting Burden 1
|Activity||Number of respondents||Number of responses per
respondent||Total annual responses||Average burden per response||Total hours|
|Individual Indepth Interviews||360||1||360||0.75 (45 minutes)||270|
|General Public Focus Group Interviews||144||1||144||1.5||216|
|Intercept Interviews: Central Location||200||1||200||0.25 (15 minutes)||50|
|Intercept Interviews: Telephone||4,000||1||4,000||0.08 (5 minutes)||320|
|Self-Administered Surveys||2,400||1||2,400||0.25 (15 minutes)||600|
|Gatekeeper Reviews||400||1||400||0.5 (30 minutes)||200|
|Omnibus Surveys||1,200||1||1,200||0.17 (10 minutes)||204|
|Total (General Public)||8,704||8,702||1,860|
|Physician Focus Group Interviews||144||1||144||1.5||216|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
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Dated: February 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02531 Filed 2-7-20; 8:45 am]
BILLING CODE 4164-01-P