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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices TABLE 2ESTIMATED ANNUAL REPORTING BURDEN 1Continued Activity
Number of responses per respondent
Number of respondents
Number of nonrespondents
Number of responses per nonrespondent
Total annual nonresponses
Average burden per response
Total hours
20212022 Data Collection-Completion of Section 2All Facility Types

800

1

800

0.5 30
minutes
400

20212022 Data Collection-Entry RefusalsAll Facility Types

16

1

16

0.08 5
minutes
1.28

Total Hours

1,637.28

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.
II. References The following references are on display in the Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240402
7500 and are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are also available electronically at https
www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

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Total annual responses
1. FDA, Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors 2000. Available at https wayback.archive-it.org/7993/
20170406023019/https www.fda.gov/
downloads/Food/GuidanceRegulation/
UCM123546.pdf.
2. FDA, FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types 2004. Available at https wayback.archive-it.org/7993/
20170406023011/https www.fda.gov/
downloads/Food/GuidanceRegulation/
RetailFoodProtection/
FoodborneIllnessRiskFactorReduction/
UCM423850.pdf.
3. FDA, FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types 2009. Available at https wayback.archive-it.org/7993/
20170406023004/https www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/
FoodborneIllnessRiskFactorReduction/
ucm224321.htm.
4. FDA National Retail Food Team, FDA
Trend Analysis Report on the Occurrence of Foodborne Illness Risk
VerDate Sep<11>2014

19:19 Jul 28, 2021

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Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types 19982008.
2010. Available at https
wayback.archive-it.org/7993/
20170406022950/https www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/
FoodborneIllnessRiskFactorReduction/
ucm223293.htm.
5. FDA, FDA Food Code. Available at https www.fda.gov/FoodCode.
Dated: July 26, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116199 Filed 72821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Document Identifier: OS0990New
Agency Information Collection Request; 60-Day Public Comment Request Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary OS, Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
DATES: Comments on the ICR must be received on or before September 27, 2021.
SUMMARY:

Submit your comments to Sherrette.Funn@hhs.gov or by calling 202 7957714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or requesting information, please include the document identifier 0990New60D
and project title for reference, to ADDRESSES:

PO 00000

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Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call 202
7957714 the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: 1 The necessity and utility of the proposed information collection for the proper performance of the agencys functions; 2 the accuracy of the estimated burden; 3 ways to enhance the quality, utility, and clarity of the information to be collected; and 4 the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Title of the Collection: Institutional Review Board IRB Records for HHS/
OASH Consultation Process.
Type of Collection: New.
OMB No.: OS0990New.
Abstract: The Office of the Assistant Secretary for Health, Office for Human Research Protections is requesting a new approval from the Office of Management and Budget of the Office for Human Research Protections OHRP
requirement that Institutional Review Board records be submitted when an IRB or its institution request an HHS
consultation process, for proposed research involving, respectively: 1
Pregnant women, human fetuses and neonates; 2 prisoners; or, 3 children, as subjects that are not otherwise approval by an IRB. The Office of the Assistant Secretary for Health, on behalf of the Secretary of HHS, may determine that such research can be conducted or supported by HHS after consulting with experts and allowing for public review of, and comment on, the proposed research.
Likely Respondents: Institutional Review Boards IRBs.

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