Document ID: FDA-2018-N-1903-0004
Agency: fda
Document Type: Notice
Title: Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program; Reopening of
Submission Period
Posted Date: 2019-08-30T04:00Z

[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45779-45780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18771]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1903]

Modernizing Pharmaceutical Quality Systems; Studying Quality 
Metrics and Quality Culture; Quality Metrics Feedback Program; 
Reopening of Submission Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of submission period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the submission period for the notice entitled ``Modernizing 
Pharmaceutical Quality Systems; Studying Quality Metrics and Quality 
Culture; Quality Metrics Feedback Program'' that published in the 
Federal Register of June 29, 2018. The Agency is taking this action to 
allow interested persons additional time to participate in the program.

DATES: FDA is reopening the submission period for the notice published 
on June 29, 2018 (83 FR 30748). Submit written

[[Page 45780]]

requests to participate in the program by December 30, 2019 to ensure 
that the Agency considers your participation in this program.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6649, Silver Spring, MD 20993, 301-796-
3257, Tara.Gooen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 29, 2018 (83 
FR 30748), FDA published a notice with a 1-year and 30-day period to 
submit a request to participate in the ``Modernizing Pharmaceutical 
Quality Systems; Studying Quality Metrics and Quality Culture; Quality 
Metrics Feedback Program.'' FDA is reopening the submission period 
until December 30, 2019. The Agency believes that an additional 120 
days will allow adequate time for interested persons to participate 
without compromising the program.
    To be considered for the program, a company should submit a 
statement of interest for participation to OPQ-OS-QualityMetrics@fda.hhs.gov. The statement of interest should include 
agreement to the selection qualities listed in 83 FR 30748 at 30749-
30750, section III.A.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18771 Filed 8-29-19; 8:45 am]
 BILLING CODE 4164-01-P