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U.S. Department of Health and Human Services

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Percentage of new or reformulated infant formula notification reviews completed during the month within 90 days of filing

Dictionary: Timely review of notifications for new and reformulated infant formulas is essential for protecting the health and well being of infants. Since these statutory requirements are notifications rather than pre-market approvals, it is essential that the Office of Nutrition and Food Labeling (ONFL) has completed review of the information before the submitter markets the product to notify them of any safety or regulatory concerns before the product reaches consumers.

Information is current as of June 30, 2020.

Fiscal Year - 2020

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TimeTargetPercentage
Oct 2019N/A100
Nov 2019N/A0
Dec 2019N/A100
Jan 2020N/A100
Feb 2020N/A83
Mar 2020N/A100
Apr 2020N/A50
May 2020N/A100
Jun 2020N/A100
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 85%

Footnotes

  • During the government shutdown (furlough) from December 22, 2018 through January 25, 2019, the majority of CFSAN employees were on furlough status, which directly impacted the FY 2019 Q2 data for various food safety programs. Because the furloughed staff were not permitted to work, CFSAN’s ability to accomplish many performance targets, including conducting timely reviews of industry submissions received during the shutdown were either delayed, deferred to the next reporting cycle, or, not met.

Number of new or reformulated infant formula notification reviews due to be completed during the month

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A1
Nov 2019N/A2
Dec 2019N/A2
Jan 2020N/A2
Feb 2020N/A6
Mar 2020N/A4
Apr 2020N/A2
May 2020N/A4
Jun 2020N/A4
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 27

Number of infant formula notification reviews completed during the month within 90 days of filing

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A1
Nov 2019N/A0
Dec 2019N/A2
Jan 2020N/A2
Feb 2020N/A5
Mar 2020N/A4
Apr 2020N/A1
May 2020N/A4
Jun 2020N/A4
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 23

Total number of infant formula notification reviews completed during the month

Fiscal Year - 2020
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2019N/A1
Nov 2019N/A0
Dec 2019N/A2
Jan 2020N/A4
Feb 2020N/A6
Mar 2020N/A4
Apr 2020N/A2
May 2020N/A5
Jun 2020N/A4
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 28

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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