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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs 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.
Generic Clearance for Quantitative Testing for the Development of FDA
Communications OMB Control Number 09100865
Extension This notice requests extension of OMB approval of the FDA information collection for a generic clearance that allows 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 FDAregulated 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 FDAs 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 an individual generic collection submission 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 FDAs 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.
We estimate the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
Average burden per response
Total annual disclosures
Total hours
Cognitive Interviews Screener
Cognitive Interviews
Pre-test Study Screener
Pre-test Study
Self-administered Surveys/Experimental Studies Screener.
Self-administered Surveys/Experimental Studies
720
144
2,400
480
75,000

1
1 1
1 1

720
144
2,400
480
75,000

0.083 5 minutes
1
0.083 5 minutes
0.25 15 minutes
0.083 5 minutes

60
144
199
120
6,225

15,000

1

15,000

0.25 15 minutes

3,750

Total

10,498

1 There
lotter on DSK11XQN23PROD with NOTICES1

Number of disclosures per respondent
Number of respondents
Survey type
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. 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
Dated: September 3, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

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.

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
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vary, depending on the nature of the compliance efforts and the target audience.

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health National Institute on Drug Abuse;
Notice of Closed Meeting Pursuant to section 10d of the Federal Advisory Committee Act, as public policies or important private sector decisions.

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