[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]
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