Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery

• Citation: 91 FR 55600
• Published date: 28 August 2026
• FR Document: 2026-17605
• Pages: 55600-55602
• Section: Notices
• Issuer: Health and Human Services Department,Food and Drug Administration

Federal Register, Volume 91 Issue 166 (Friday, August 28, 2026)

[Federal Register Volume 91, Number 166 (Friday, August 28, 2026)]
                [Notices]
                [Pages 55600-55602]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2026-17605]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2026-N-8898]
                Agency Information Collection Activities; Proposed Collection;
                Comment Request; Qualitative Feedback on Agency Service Delivery
                AGENCY: Food and Drug Administration, 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 a generic collection of information through
                which we intend to seek insights into customer or stakeholder
                perceptions, experiences and expectations, provide an early warning of
                issues with service, or focus attention on areas where communication,
                training, or changes in
                [[Page 55601]]
                operations might improve delivery of products or services.
                DATES: Either electronic or written comments on the collection of
                information must be submitted by October 27, 2026.
                ADDRESSES: You may submit comments as follows. Please note that late,
                untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
                11:59 p.m. Eastern Time at the end of October 27, 2026. Comments
                received by mail/hand delivery/courier (for written/paper submissions)
                will be considered timely if they are received 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-2026-N-8898 for '' Agency Information Collection Activities;
                Proposed Collection; Comment Request; Qualitative Feedback on Agency
                Service Delivery.'' 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: Amber Barrett, Office of Operations,
                Food and Drug Administration, Three White Flint North, 10A-12M, 11601
                Landsdown St., North Bethesda, MD 20852, 301-796-8867,
                [email protected].
                SUPPLEMENTARY INFORMATION: Under thePRAA 44 U.S.C. 3501-35211), 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 thePRAA 44 U.S.C. 3506(c)(2)(A)))
                requires Federal Agencies to provide a 60-day notice in theFederal
                Registerr 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 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.
                Qualitative Feedback on Agency Service Delivery
                OMB Control Number 0910-0697--Extension
                 FDA will collect qualitative customer and stakeholder feedback
                using a variety of methods to gain useful insights into customer or
                stakeholder perceptions, experiences, and expectations; provide an
                early warning of issues with service; or focus attention on areas where
                communication, training, or changes in operations might improve the
                delivery of products or services. These collections will allow for
                ongoing, collaborative, and actionable communications between the
                Agency and its customers and stakeholders. They will also allow
                feedback to contribute directly to the improvement of program
                management.
                 Information collected under this generic clearance will provide
                valuable
                [[Page 55602]]
                qualitative insights but will not yield data that can be generalized to
                the overall population. This type of generic clearance for qualitative
                information will not be used for quantitative information collection
                designed to produce reliably actionable results, such as monitoring
                trends over time or documenting program performance.
                 Respondents to this collection of information represent a broad
                range of customers and stakeholders who have specific characteristics
                related to certain products or services regulated by FDA. These
                stakeholders include members of the general public, healthcare
                professionals, industry, and others who have experience with a product
                under FDA's jurisdiction.
                 FDA estimates the burden of this collection of information as
                follows:
                 Table 1--Estimated Annual Reporting Burden \1\
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                 Number of
                 Activity Number of responses per Total annual Average burden per Total hours
                 respondents respondent responses response
                ----------------------------------------------------------------------------------------------------------------
                Focus groups................... 3,000 1 3,000 1.75.............. 5,250
                Customer comment cards/forms... 1,500 1 1,500 0.25 (15 minutes). 375
                Small discussion groups........ 800 1 800 1.75.............. 1,400
                Customer satisfaction surveys.. 20,000 1 20,000 0.33 (20 minutes). 6,600
                Usability studies.............. 1,100 1 1,100 1................. 1,100
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                 Total...................... .............. .............. .............. .................. 14,725
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                \1\ 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.
                Grace R. Graham,
                Deputy Commissioner for Policy, Legislation, and International Affairs.
                [FR Doc. 2026-17605 Filed 8-27-26; 8:45 am]
                BILLINGCODE 4164-01-PP