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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2018-N-3037]
 AGENCY: Food and Drug Administration, Health and Human Services (HHS).
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the 
                        **Federal Register**
                         concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications,” which collects individual generic quantitative information (
                        *e.g.,*
                         surveys, experimental studies) to test communications or educational messages on FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed while they are being developed or are in review.
 DATES: Submit either electronic or written comments on the collection of information by November 8, 2021.
 ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 8, 2021. The 
                        *https://www.regulations.gov*
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 8, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: *Federal eRulemaking Portal:**https://www.regulations.gov.*
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    *https://www.regulations.gov*
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    *https://www.regulations.gov.*
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows: *Mail/Hand Delivery/Courier (for written/paper submissions):*
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” *Instructions:*
                     All submissions received must include the Docket No. FDA-2018-N-3037 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications.” Received comments, those filed in a timely manner (see 
                    **ADDRESSES**
                    ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    *https://www.regulations.gov*
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on*https://www.regulations.gov.*
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    *https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.* *Docket:*
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    *https://www.regulations.gov*
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
 FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
                        *PRAStaff@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the 
                    **Federal Register**
                     concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether 
                    ( print page 50545)
                    the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's 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 0910-0865—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 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 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 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. We estimate the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden by Anticipated Data Collection Methods 1
Survey type
Number of 
                             respondents
Number of 
                             disclosures  
                             per  
                             respondent
Total annual 
                             disclosures
Average 
                             burden  
                             per response
Total 
                             hoursCognitive Interviews Screener
720
1
720
0.083 (5 minutes)
60Cognitive Interviews
144
1
144
1
144Pre-test Study Screener
2,400
1
2,400
0.083 (5 minutes)
199Pre-test Study
480
1
480
0.25 (15 minutes)
120Self-administered Surveys/Experimental Studies Screener
75,000
1
75,000
0.083 (5 minutes)
6,225Self-administered Surveys/Experimental Studies
15,000
1
15,000
0.25 (15 minutes)
3,750Total




10,4981
                         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. 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. Dated: September 3, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.


# Footnotes

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. Back to Citation
 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.” Back to Citation


[FR Doc. 2021-19480 Filed 9-8-21; 8:45 am] BILLING CODE 4164-01-P