[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38638-38639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16878]
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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.
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
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:
[[Page 38639]]
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 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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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 at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm.
II. Fiscal Year 2018 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) 2018 (i.e., as of September 30,
2018). 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 of
establishment \2\ (FY2012 to FY2018) for PMRs and PMCs open at the end
of FY2018, or those closed within FY2018. 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: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16878 Filed 8-6-19; 8:45 am]
BILLING CODE 4164-01-P