Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 70181-70182 [2020-24422]

Download as PDF 70181 Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices given the anticipated circumstances of use of the product; • provide copies of the proposed labeling of the specified lots, batches, or other units of the affected product that will be subject to the exception or alternative; and • provide any other information requested by the FDA Center Director in support of the request. If the request is granted, the manufacturer may need to report to FDA any resulting changes to the new drug application, biologics license application, premarket approval application, or premarket notification (510(k)) in effect, if any. The submission and grant of an exception or an alternative to the labeling requirements specified in the regulations may be used to satisfy certain reporting obligations relating to changes to product applications under §§ 314.70, 601.12, 814.39, or 807.81 (21 CFR 314.70 (human drugs), 601.12 (biological products), 814.39 (medical devices subject to premarket approval), or 807.81 (medical devices subject to 510(k) clearance requirements)). The information collection provisions in §§ 314.70, 601.12, 807.81, and 814.39 have been approved under OMB control numbers 0910–0001, 0910–0338, 0910– 0120, and 0910–0231, respectively. On a case-by-case basis, the appropriate FDA Center Director may also determine when an exception or alternative is granted that certain safeguards and conditions are appropriate, such as additional labeling on the SNS products, so that the labeling of such products would include information needed for safe and effective use under the anticipated circumstances of use. Respondents to this collection of information are entities that manufacture (including labeling, packing, relabeling, or repackaging), distribute or store affected SNS products. Based on data from fiscal years 2017, 2018, and 2019, FDA estimates an average of one request annually for an exception or alternative received by FDA. FDA estimates an average of 24 hours preparing each request. The average burden per response for each submission is based on the estimated time that it takes to prepare a supplement to an application, which may be considered similar to a request for an exception or alternative. To the extent that labeling changes not already required by FDA regulations are made in connection with an exception or alternative granted under the regulations, FDA is estimating one occurrence annually in the event FDA would require any additional labeling changes not already covered by FDA regulations. FDA estimates 8 hours to develop and revise the labeling to make such changes. The average burden per response for each submission is based on the estimated time to develop and revise the labeling to make such changes. In the Federal Register of July 2, 2020 (85 FR 39914), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but was not responsive to the four information collection topics solicited and is therefore not addressed in this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 201.26(b)(1)(i), 809.11(b)(1)(i) 201.26(b)(1)(i), 809.11(b)(1)(i) 610.68(b)(1)(i), 801.128(b)(1)(i), and ................................................................... 610.68(b)(1)(i), 801.128(b)(1)(i), and ................................................................... Total .............................................................................. 1 There Average burden per response (in hours) Total annual responses Total hours 1 1 1 24 24 1 1 1 8 8 ........................ ........................ ........................ ........................ 32 are no capital costs or operating and maintenance costs associated with this collection of information. Consistent with the PRA, our current estimate of the burden of the information collection is based on our evaluation over the past 3 years. However, in light of recent consumption of products from the SNS, we expect future adjustments may be necessary and invite specific comment in this regard. Dated: October 30, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. khammond on DSKJM1Z7X2PROD with NOTICES Number of responses per respondent Number of respondents 21 CFR Section DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0487] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY: [FR Doc. 2020–24427 Filed 11–3–20; 8:45 am] HHS. BILLING CODE 4164–01–P ACTION: Food and Drug Administration, Notice. 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. SUMMARY: VerDate Sep<11>2014 18:16 Nov 03, 2020 Jkt 253001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Submit written comments (including recommendations) on the collection of information by December 4, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0697. Also include the FDA docket number found in brackets in the heading of this document. DATES: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD FOR FURTHER INFORMATION CONTACT: E:\FR\FM\04NON1.SGM 04NON1 70182 Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices 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 the Collection of Qualitative Feedback on Agency Service Delivery OMB Control Number 0910–0697— Extension The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide 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 delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it 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 collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address the following: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non- response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. Respondents to this collection of information cover a broad range of stakeholders who have specific characteristics related to certain products or services regulated by FDA. These stakeholders include members of the general public, healthcare professionals, the industry, and other stakeholders who are related to a product under FDA’s jurisdiction. In the Federal Register of April 3, 2020 (85 FR 18989), we published a 60day notice requesting public comment on the proposed collection of information. Although two comments were received, they were not responsive to the four collection of information topics solicited and therefore will not be discussed in this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Average burden per response Total annual responses Total hours Focus groups ....................................................................... Customer comment cards/forms .......................................... Small discussion groups ...................................................... Customer satisfaction surveys ............................................. Usability Studies .................................................................. 800 1,325 800 12,000 800 1 1 1 1 1 800 1,325 800 12,000 800 1.75 * .25 1.75 † .33 1.75 1,400 331.25 1,400 3,960 1,400 Total .............................................................................. ........................ ........................ ........................ ........................ 8,491.25 khammond on DSKJM1Z7X2PROD with NOTICES * (15 minutes). † (20 minutes). In the 60-day notice published on April 3, 2020, the number of responses and number of burden hours did not match OMB approved inventory. This notice corrects the burden in table 1 of that notice. In addition, the burden for this collection of information has increased by 800 responses from 14,925 to 15,725 responses due to an inadvertent omission of responses of usability studies for this collection. This addition to responses will correct the number of responses for this collection. The burden hours in OMB’s inventory will remain the same. Dated: October 30, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–24422 Filed 11–3–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:16 Nov 03, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0369] Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA). DATES: Submit either electronic or written comments on the collection of information by January 4, 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 January 4, 2021. The https://www.regulations.gov electronic filing system will accept E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70181-70182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0487]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
the Collection of Qualitative Feedback on Agency Service Delivery

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.

DATES: Submit written comments (including recommendations) on the 
collection of information by December 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0697. 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

[[Page 70182]]

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 the Collection of Qualitative Feedback on Agency 
Service Delivery

OMB Control Number 0910-0697--Extension

    The information collection activity will garner qualitative 
customer and stakeholder feedback in an efficient, timely manner, in 
accordance with the Administration's commitment to improving service 
delivery. By qualitative feedback we mean information that provides 
useful insights on perceptions and opinions but are not statistical 
surveys that yield quantitative results that can be generalized to the 
population of study. This feedback will provide 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 delivery 
of products or services. These collections will allow for ongoing, 
collaborative, and actionable communications between the Agency and its 
customers and stakeholders. It will also allow feedback to contribute 
directly to the improvement of program management.
    Feedback collected under this generic clearance will provide useful 
information, but it 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 collections 
that are designed to yield reliably actionable results, such as 
monitoring trends over time or documenting program performance. Such 
data uses require more rigorous designs that address the following: The 
target population to which generalizations will be made, the sampling 
frame, the sample design (including stratification and clustering), the 
precision requirements or power calculations that justify the proposed 
sample size, the expected response rate, methods for assessing 
potential non-response bias, the protocols for data collection, and any 
testing procedures that were or will be undertaken prior to fielding 
the study. Depending on the degree of influence the results are likely 
to have, such collections may still be eligible for submission for 
other generic mechanisms that are designed to yield quantitative 
results.
    Respondents to this collection of information cover a broad range 
of stakeholders who have specific characteristics related to certain 
products or services regulated by FDA. These stakeholders include 
members of the general public, healthcare professionals, the industry, 
and other stakeholders who are related to a product under FDA's 
jurisdiction.
    In the Federal Register of April 3, 2020 (85 FR 18989), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, they 
were not responsive to the four collection of information topics 
solicited and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Focus groups....................             800               1             800            1.75           1,400
Customer comment cards/forms....           1,325               1           1,325           * .25          331.25
Small discussion groups.........             800               1             800            1.75           1,400
Customer satisfaction surveys...          12,000               1          12,000    [dagger] .33           3,960
Usability Studies...............             800               1             800            1.75           1,400
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............        8,491.25
----------------------------------------------------------------------------------------------------------------
* (15 minutes).
[dagger] (20 minutes).

    In the 60-day notice published on April 3, 2020, the number of 
responses and number of burden hours did not match OMB approved 
inventory. This notice corrects the burden in table 1 of that notice. 
In addition, the burden for this collection of information has 
increased by 800 responses from 14,925 to 15,725 responses due to an 
inadvertent omission of responses of usability studies for this 
collection. This addition to responses will correct the number of 
responses for this collection. The burden hours in OMB's inventory will 
remain the same.

    Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24422 Filed 11-3-20; 8:45 am]
BILLING CODE 4164-01-P
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