Document ID: FDA-2019-N-0430-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Posted Date: 2019-07-23T04:00Z

[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35392-35393]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-15623]

-----------------------------------------------------------------------

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 [email protected]. 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, 
[email protected].

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

    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,

[[Page 35393]]

these methods of communication might be used when there is a foodborne 
illness outbreak, food recall, or other situation requiring expedited 
FDA food, dietary supplement, cosmetics, or animal food or feed 
communications. So that FDA may better protect the public health, the 
Agency needs quick turnaround information to help ensure its messaging 
has reached the target audience, has been effective, and, if needed, to 
update its communications during these events.
    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;
---------------------------------------------------------------------------

    \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
---------------------------------------------------------------------------

    \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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                 Survey type                     Number of     responses per   Total annual        Average burden hours per response        Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-depth Interviews, Cognitive Interviews                 45               1              45  0.083 (5 minutes).........................               4
 Screener.
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                180               1             180  0.083 (5 minutes).........................              15
 Screener.
Focus Group/Small Group, Cognitive Groups...              60               1              60  1.5 (90 minutes)..........................              90
Focus Group/Small Group Participant                      720               1             720  0.083 (5 minutes).........................              60
 Screening.
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