Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34877 

and privilege protections of the Patient 

Safety Act. 

The CFER–DS is the first AHRQ 

Common Formats for Event Reporting 

that can be used across healthcare 

settings. It is designed to capture 

standardized, structured data to 

facilitate the reporting of diagnostic 

safety events for the purpose of learning 

about how to improve diagnostic safety 

and better support the diagnostic 

process. 

The CFER–DS is not designed for 

frontline incident reporting. It is 

intended to facilitate the collection and 

organization of a basic set of meaningful 

data about diagnostic safety events that 

can be used, aggregated and analyzed 

for learning and improvement. Having a 

common frame of reference and 

standardized data elements makes 

shared learning possible at local, 

regional, and national levels. Users 

decide if and how to integrate collection 

of specific CFER data elements into 

their incident reporting systems and 

other existing work processes. 

At this time, AHRQ is releasing the 

CFER–DS Version 1.0 Event Description 

and some supporting materials, 

including the Users’ Guide and Form. A 

Sample Preliminary Clinician Event 

Report is also being made available as 

a convenience for optional use or 

adaptation as a supporting resource to 

the CFER–DS. Additional supporting 

documents and technical specifications 

for the CFER–DS (e.g., Data Dictionary, 

Flow Charts, Resources Workbook) are 

anticipated to be released in Fall 2022. 

Information on how to comment on 

Common Formats is available at: http:// 

www.qualityforum.org/Project_Pages/ 

Common_Formats_for_Patient_Safety_

Data.aspx. 

Additional information about the 

AHRQ Common Formats can be 

obtained through AHRQ’s PSO website: 

https://pso.ahrq.gov/common-formats. 

Dated: June 3, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–12353 Filed 6–7–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0618] 

Advisory Committee; Drug Safety and 

Risk Management Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Drug Safety and Risk 

Management Advisory Committee by 

the Commissioner of Food and Drugs 

(the Commissioner). The Commissioner 

has determined that it is in the public 

interest to renew the Drug Safety and 

Risk Management Advisory Committee 

for an additional 2 years beyond the 

charter expiration date. The new charter 

will be in effect until the May 31, 2024, 

expiration date. 

DATES: Authority for the Drug Safety 

and Risk Management Advisory 

Committee will expire on May 31, 2024, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Philip Bautista, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 240– 

762–8729, DSaRM@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services (HHS) and by the General 

Services Administration, FDA is 

announcing the renewal of the Drug 

Safety and Risk Management Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

information on risk management, risk 

communication, and quantitative 

evaluation of spontaneous reports for 

drugs for human use and for any other 

product for which FDA has regulatory 

responsibility. The Committee also 

advises the Commissioner regarding the 

scientific and medical evaluation of all 

information gathered by HHS and the 

Department of Justice with regard to 

safety, efficacy, and abuse potential of 

drugs or other substances, and 

recommends actions to be taken by HHS 

with regard to the marketing, 

investigation, and control of such drugs 

or other substances. 

The Committee shall consist of a core 

of 11 voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of risk 

communication, risk management, drug 

safety, medical, behavioral, and 

biological sciences as they apply to risk 

management, and drug abuse. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Non-Federal 

members of this committee will serve as 

Special Government Employees, 

representatives, or Ex-Officio members. 

Federal members will serve as Regular 

Government Employees or Ex-Officios. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include one non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/drugsafety-and-risk-management-advisorycommittee/drug-safety-and-riskmanagement-advisory-committeecharter or by contacting the Designated 

Federal Officer (see FOR FURTHER

INFORMATION CONTACT). In light of the 

fact that no change has been made to the 

committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12369 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0622] 

Advisory Committee; PulmonaryAllergy Drugs Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 


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