Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability, 47799 [2020-17113]

Download as PDF Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices Dated: August 3, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–17177 Filed 8–5–20; 8:45 am] BILLING CODE 4164–01–P 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. 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. 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: jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: 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 §§ 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 VerDate Sep<11>2014 17:13 Aug 05, 2020 Jkt 250001 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 §§ 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. II. Fiscal Year 2019 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) 2019 (i.e., as of September 30, 2019). 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 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. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 47799 (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in § 314.81(b)(2)(vii) or § 601.70 ASRs; (5) the status of closed PMRs/PMCs; and (6) the distribution of the status by fiscal year of establishment 2 (FY2013 to FY2019) for PMRs and PMCs open at the end of FY2019, or those closed within FY2019. Additional information about PMRs/PMCs is provided on FDA’s website at https://www.fda.gov/drugs/ guidance-compliance-regulatoryinformation/postmarket-requirementsand-commitments. Dated: July 31, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–17113 Filed 8–5–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2032] Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This guidance finalizes the draft guidance of the same name issued on June 13, 2018. DATES: The announcement of the guidance is published in the Federal Register on August 6, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the 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. E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Page 47799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17113]


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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.

-----------------------------------------------------------------------

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.

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:

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.
---------------------------------------------------------------------------

    \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 2019 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) 2019 (i.e., as of September 30, 
2019). 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\ (FY2013 to FY2019) for PMRs and PMCs open at the end 
of FY2019, or those closed within FY2019. Additional information about 
PMRs/PMCs is provided on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments.
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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: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17113 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P

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