[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7094-7095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]


Report on the Performance of Drug and Biologics Firms in 
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the Agency's annual report entitled ``Report on the 
Performance of Drug and Biologics Firms in Conducting Postmarketing 
Requirements and Commitments.'' Under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), FDA is required to report annually on the 
status of postmarketing requirements (PMRs) and postmarketing 
commitments (PMCs) required of, or agreed upon by, application holders 
of approved drug and biological products. The report on the status of 
the studies and clinical trials that applicants are required to, or 
have agreed to, conduct is on FDA's website entitled ``Postmarketing 
Requirements and Commitments: Reports'' (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm).

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002, 301-796-0700; or 
Diane Maloney, Center for Biologics

[[Page 7095]]

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7242, Silver Spring, MD 20993-0002, 240-
402-8113.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to 
publish an annual report on the status of postmarketing studies that 
applicants are required to, or have committed to, conduct and for which 
annual status reports have been submitted. Under Sec. Sec.  
314.81(b)(2)(vii) and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70), 
applicants of approved drug products and licensed biological products 
are required to submit annually a report on the status of each clinical 
safety, clinical efficacy, clinical pharmacology, and nonclinical 
toxicology study or clinical trial either required by FDA (PMRs) or 
that they have committed to conduct (PMCs), either at the time of 
approval or after approval of their new drug application, abbreviated 
new drug application, or biologics license application, as applicable. 
The status of PMCs concerning chemistry, manufacturing, and production 
controls and the status of other studies or clinical trials conducted 
on an applicant's own initiative are not required to be reported under 
Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not addressed in this 
report. Furthermore, section 505(o)(3)(E) of the FD&C Act (21 U.S.C. 
355(o)(3)(E)) requires that applicants report periodically on the 
status of each required study or clinical trial and each study or 
clinical trial ``otherwise undertakento investigate a safety issue . . 
. .''
    An applicant must report on the progress of the PMR/PMC on the 
anniversary of the drug product's approval \1\ until the PMR/PMC is 
completed or terminated and FDA determines that the PMR/PMC has been 
fulfilled or that the PMR/PMC is either no longer feasible or would no 
longer provide useful information.
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    \1\ An applicant must submit an annual status report on the 
progress of each open PMR/PMC within 60 days of the anniversary date 
of U.S. approval of the original application or on an alternate 
reporting date that was granted by FDA in writing. Some applicants 
have requested and been granted by FDA alternate annual reporting 
dates to facilitate harmonized reporting across multiple 
applications.
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II. Fiscal Year 2021 Report

    With this notice, FDA is announcing the availability of the 
Agency's annual report entitled ``Report on the Performance of Drug and 
Biologics Firms in Conducting Postmarketing Requirements and 
Commitments.'' Information in this report covers any PMR/PMC that was 
established, in writing, at the time of approval or after approval of 
an application or a supplement to an application and summarizes the 
status of PMRs/PMCs in fiscal year (FY) 2021 (i.e., as of September 30, 
2021). Information summarized in the report reflects combined data from 
the Center for Drug Evaluation and Research and the Center for 
Biologics Evaluation and Research and includes the following: (1) the 
number of applicants with open PMRs/PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant submission of the annual status 
reports (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in 
Sec.  314.81(b)(2)(vii) or Sec.  601.70 ASRs; (5) the status of closed 
PMRs/PMCs; and (6) the distribution of the status by fiscal year (FY) 
of establishment \2\ (FY2015 to FY2021) for PMRs and PMCs open at the 
end of FY2021, or those closed within FY2021. Additional information 
about PMRs/PMCs is provided on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
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    \2\ The establishment date is the date of the formal FDA 
communication to the applicant that included the final FDA-required 
(PMR) or requested (PMC) postmarketing study or clinical trial.

    Dated: January 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02156 Filed 2-1-23; 8:45 am]
BILLING CODE 4164-01-P