23868 Federal Register / Vol. 87, No. 77 / Thursday, April 21, 2022 / Notices 

1An 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. 

2The ‘‘Report on the Performance of Drug and 

Biologics Firms in Conducting Postmarketing 

Requirements and Commitments’’ can be found on 

the FDA’s Postmarketing Requirements and 

Commitments: Reports web page: https://

www.fda.gov/drugs/postmarket-requirements-andcommitments/postmarketing-requirements-andcommitments-reports. 

3The 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. 

IV. Submission Information 

1. Application Kit 

Application Kit/Program Instructions 

are available at www.grantsolutions.gov. 

Instructions for completing the 

application kit will be available on the 

site. 

2. Submission Dates and Times 

To receive consideration, applications 

must be submitted by 11:59 p.m. Eastern 

Time on June 21, 2022, through 

www.GrantSolutions.gov. 

VII. Agency Contacts 

Direct inquiries regarding 

programmatic issues to: Margaret 

Flowers, Phone: 202.795.7315, Email: 

Margaret.Flowers@acl.hhs.gov. 

Dated: April 15, 2022. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2022–08511 Filed 4–20–22; 8:45 am] 

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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, or are required, to conduct is on 

FDA’s ‘‘Postmarketing Requirements 

and Commitments: Reports’’ web page 

(https://www.fda.gov/drugs/postmarketrequirements-and-commitments/ 

postmarketing-requirements-andcommitments-reports). 

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 §§ 314.81(b)(2)(vii) and 601.70 

(21 CFR 314.81(b)(2)(vii) and 601.70), 

applicants of approved drugs and 

licensed biological products 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. 

II. Fiscal Year 2020 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.’’ 2

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) 2020 (i.e., as of 

September 30, 2020). 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 3 (FY2014 to 

FY2020) for PMRs and PMCs open at 

the end of FY2020, or those closed 

within FY2020. Additional information 

about PMRs/PMCs is provided on FDA’s 

website at https://www.fda.gov/drugs/ 

guidance-compliance-regulatoryinformation/postmarket-requirementsand-commitments. 

Dated: April 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08499 Filed 4–20–22; 8:45 am] 

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