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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
XI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995
44 U.S.C. 35013521. A description of these provisions is given in the Description section with an estimate of the annual recordkeeping burden.
Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

FDA invites comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility;
2 the accuracy of FDAs 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.

Title: Standards for the Growing, Harvesting, Packing, and Holding of Produce; RecordkeepingOMB Control Number 09100816Revision.
Description: The proposed rule would replace current recordkeeping requirements found in 21 CFR part 112, subpart E associated with sampling and testing of pre-harvest agricultural water for non-sprout covered produce with revised requirements to prepare and maintain documentation of written agricultural water assessments for certain pre-harvest agricultural water.
Description of Respondents: Farms subject to the regulation in part 112.
We estimate the burden of the information collection as follows:

TABLE 5CUMULATIVE AVERAGE ANNUAL BURDEN, COVERED FARMS OF ALL SIZES
21 CFR part 112, subpart E: Requirements that apply regarding records Agricultural Water Assessment and Records MaintenanceVery small covered farms proposed 112.50b2
Agricultural Water Assessment and Records MaintenanceSmall covered farms proposed 112.50b2
Agricultural Water Assessment and Records MaintenanceAll other Large Covered Farms proposed 112.50b2
Cumulative totals for covered farms of all sizes

Total number of respondents
Number of records per respondent
Total annual records
Average burden per farm in hours
Total hours
8,218

1.1

9,040

4

36,160

1,613

1.1

1,774

8

14,192

4,283

1.1

4,711

9

42,399

14,114

3.3

15,525

7.0

92,751

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Cumulative average 7.0 burden hours per covered farm annually
Covered farms using pre-harvest agricultural water for non-sprout covered produce would prepare and maintain records of their agricultural water assessments unless excluded under proposed 112.43b. We estimate that a total of 14,114 covered farms 8,218 very small farms, 1,613
small farms, and 4,283 other large covered farms would be subject to information collection requirements under the proposed rule, consistent with figures in our current approval and our PRIA Ref. 79 for this proposed rule and informed by a 2018 USDA survey of covered farms irrigation practices Ref. 82. We are estimating a range of burden: 4 hours of burden for very small farms, 8 hours of burden for small farms, and 9 hours for other large farms, based on estimates of the amount of time in hours to conduct recordkeeping for pre-harvest agricultural water assessments.
To ensure that comments on information collection are received, OMB recommends that written comments be submitted through reginfo.gov see ADDRESSES. All
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comments should be identified with the title of the information collection.
In compliance with the Paperwork Reduction Act of 1995 44 U.S.C.
3407d, we have submitted the information collection provisions of this proposed rule to OMB for review. These information collection requirements will not be effective until FDA
publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect. FDA will announce OMB approval of these requirements in the Federal Register.
XII. Federalism We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive
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Order and, consequently, a federalism summary impact statement is not required.
XIII. Consultation and Coordination With Tribal Governments We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
We invite comments from tribal officials on any potential impact on Indian Tribes from this proposed action.
XIV. References The following references marked with an asterisk are on display at the Dockets Management Staff see ADDRESSES and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https

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