[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58259-58260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25128]


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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 have agreed to, or are 
required to, conduct is on the FDA's ``Postmarketing Requirements and 
Commitments: Reports'' web page (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm).

FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

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 study 
commitments that applicants have committed to, or are required 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 drugs and 
licensed biologics 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. 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 undertaken . . . to 
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 2017 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) 2017 (i.e., as of September 30, 
2017). 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

[[Page 58260]]

(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 of 
establishment \2\ (FY2011 to FY2017) for PMRs and PMCs open at the end 
of FY2017, or those closed within FY2017. 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: November 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25128 Filed 11-16-18; 8:45 am]
 BILLING CODE 4164-01-P