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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications

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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 (PRA).


Fax written comments on the collection of information by January 28, 2019.


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 All comments should be identified with the OMB control number 0910-New and title “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” Also include the FDA docket number found in brackets in the heading of this document.

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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,

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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.

Generic Clearance for Quantitative Testing for the Development of FDA Communications

OMB Control Number 0910—NEW

This notice announces the FDA information collection request from OMB for a generic clearance that will allow FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers' reactions to FDA communications or educational messaging about FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. To ensure that communications activities and educational campaigns have the highest potential to be received, understood, and accepted by those for whom they are intended, it is important to assess communications while they are under development. Understanding consumers' attitudes, motivations, and behaviors in response to potential communications and education messaging plays an important role in improving FDA's communications.

If the following conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process:

  • The collections are voluntary;
  • The collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government;
  • The collections are noncontroversial;
  • Personally identifiable information (PII) is collected only to the extent necessary [1] and is not retained;
  • Information gathered will not be used for the purpose of substantially informing influential policy decisions; [2] and
  • Information gathered will yield qualitative findings; the collections will not be designed or expected to yield statistical data or used as though the results are generalizable to the population of study.

To obtain approval for a collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB along with supporting documentation (e.g., a copy of the survey or experimental design and stimuli for testing).

FDA will submit individual quantitative collections under this generic clearance to OMB. Individual quantitative collections will also undergo review by FDA's Research Involving Human Subjects Committee, senior leadership in the Center for Food Safety and Applied Nutrition, and PRA specialists.

Respondents to this collection of information may include a wide range of consumers and other FDA stakeholders such as producers and manufacturers who are regulated under FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed.

In the Federal Register of September 4, 2018 (83 FR 44888), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden, by Anticipated Data Collection Methods

Survey typeNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
Cognitive Interviews Screener72017200.083 (5 minutes)60
Cognitive Interviews14411441144
Pre-test study screener2,40012,4000.083 (5 minutes)199
Pre-testing study4801480.25 (15 minutes)120
Self-administered surveys/experimental Studies Screener75,000175,0000.083 (5 minutes)6,225
Self-Administered Surveys/Experimental Studies15,000115,000.25 (15 minutes)3,750
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total estimated annual burden is 10,498 hours. Current estimates are based on both historical numbers of participants from past projects as well as estimates for projects to be conducted in the next 3 years. The number of participants to be included in each new survey will vary, depending on the nature of the compliance efforts and the target audience.

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Dated: December 21, 2018.

Leslie Kux,

Associate Commissioner for Policy.

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1.  For example, collections that collect PII to provide remuneration for participants of focus groups and cognitive laboratory studies will be submitted under this request. All Privacy Act requirements will be met.

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2.  As defined in OMB and agency Information Quality Guidelines, “influential” means that “an agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions.”

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[FR Doc. 2018-28252 Filed 12-27-18; 8:45 am]