84 FR 141 pgs. 35392-35393 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Type: NOTICEVolume: 84Number: 141Pages: 35392 - 35393
Pages: 35392, 35393Docket number: [Docket No. FDA-2019-N-0430]
FR document: [FR Doc. 2019-15623 Filed 7-22-19; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0430]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
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).
DATES:
Fax written comments on the collection of information by August 22, 2019.
ADDRESSES:
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 oira_submission@omb.eop.gov . All comments should be identified with the OMB control number 0910-New and title "Generic Clearance for Quick Turnaround Testing of Communication Effectiveness." Also include the FDA docket number found in brackets in the heading of this document.
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 .
SUPPLEMENTARY INFORMATION:
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 Quick Turnaround Testing of Communication Effectiveness
OMB Control Number 0910-NEW
[top] This notice announces the FDA information collection request to OMB for approval of a generic clearance that will allow FDA to use quick turnaround surveys, focus groups, and in-depth interviews collected from consumers and other stakeholders to communicate FDA issues of immediate and important public health significance. For example,
FDA will only submit individual collections for approval under this generic clearance if they meet the following conditions:
• 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;
Footnotes:
1 ?For example, collections that collect PII to provide remuneration for participants of focus groups, in-depth interviews, and cognitive laboratory studies will be submitted under this request. All privacy act requirements will be met.
• Information gathered will not be used for the purpose of substantially informing influential policy decisions;?2 and
Footnotes:
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."
• Information gathered will yield qualitative findings; the collections will not be designed or used as though the results are generalizable to the population of study.
If these conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process.
To obtain approval for an individual 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, focus group moderator guide, or in-depth interviewing guide).
Individual collections will also undergo review by FDA senior leadership in the Center for Food Safety and Applied Nutrition, PRA specialists, and an institutional review board.
Respondents to this collection of information 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 April 2, 2019 (84 FR 12617), 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:
| Survey type | Number of respondents | Number of responses per respondent | Total annual responses | Average burden hours per response | Total hours |
|---|---|---|---|---|---|
| In-depth Interviews, Cognitive Interviews Screener | 45 | 1 | 45 | 0.083 (5 minutes) | 4 |
| In-depth Interviews, Cognitive Interviews | 9 | 1 | 9 | 1 | 9 |
| In-depth Interviews Screener | 900 | 1 | 900 | 0.083 (5 minutes) | 75 |
| In-depth Interviews | 180 | 1 | 180 | 1 | 180 |
| Survey Cognitive Interviews Screener | 45 | 1 | 45 | 0.083 (5 minutes) | 4 |
| Survey Cognitive Interviews | 9 | 1 | 9 | 1 | 9 |
| Pretest survey screener | 750 | 1 | 750 | 0.083 (5 minutes) | 62.25 |
| Pretest survey | 150 | 1 | 150 | 0.25 (15 minutes) | 38 |
| Self-Administered Surveys-Study Screener | 75,000 | 1 | 75,000 | 0.083 (5 minutes) | 6,225 |
| Self-Administered Surveys | 15,000 | 1 | 15,000 | 0.25 (15 minutes) | 3,750 |
| Focus Group/Small Group, Cognitive Groups Screener | 180 | 1 | 180 | 0.083 (5 minutes) | 15 |
| Focus Group/Small Group, Cognitive Groups | 60 | 1 | 60 | 1.5 (90 minutes) | 90 |
| Focus Group/Small Group Participant Screening | 720 | 1 | 720 | 0.083 (5 minutes) | 60 |
| Focus Group/Small Group Discussion | 240 | 1 | 240 | 1.5 (90 minutes) | 360 |
| Total | 10,881.25 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
This is a new collection of information whose total estimated annual burden is 10,881.25 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 individual survey will vary, depending on the nature of the compliance efforts and the target audience.
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15623 Filed 7-22-19; 8:45 am]
BILLING CODE 4164-01-P