Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability, 38638-38639 [2019-16878]

Download as PDF 38638 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices [FR Doc. 2019–16881 Filed 8–6–19; 8:45 am] BILLING CODE 4164–01–C 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, jspears on DSK3GMQ082PROD with NOTICES HHS. VerDate Sep<11>2014 18:14 Aug 06, 2019 Jkt 247001 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. FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation and Research, Food and Drug SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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: E:\FR\FM\07AUN1.SGM 07AUN1 EN07AU19.001</GPH> Dated: August 1, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices 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 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. 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/Guidance ComplianceRegulatoryInformation/PostmarketingPhaseIVCommitments/ 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 § 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 (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/ GuidanceComplianceRegulatory Information/Post-marketingPhaseIV Commitments/default.htm. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB Number 0915–0327—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of jspears on DSK3GMQ082PROD with NOTICES SUMMARY: 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. VerDate Sep<11>2014 18:14 Aug 06, 2019 Jkt 247001 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. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 38639 Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than September 6, 2019. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. A 60-day notice was published in the Federal Register on May 9, 2019, vol. 84, No. 90; pp. 20373–75. There were four public comments received. Some comments addressed policy issues that are outside of the scope of this information collection request. HRSA responded to technical comments that pertain to the ICR and revised the draft instruments based on technical comments received. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915–0327— Revision. Abstract: Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service (PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed statutorily defined 340B ceiling prices. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that choose to participate in the 340B Program must E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[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.

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

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

    \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.
---------------------------------------------------------------------------

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

    \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
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