34878 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Pulmonary-Allergy Drugs 

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 Pulmonary-Allergy 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the May 30, 2024, 

expiration date. 

DATES: Authority for the PulmonaryAllergy Drugs Advisory Committee will 

expire on May 30, 2022, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Takyiah Stevenson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 240– 

402–2507, PADAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Pulmonary-Allergy Drugs 

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 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of pulmonary 

disease and diseases with allergic and/ 

or immunologic mechanisms and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

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 

pulmonary medicine, allergy, clinical 

immunology, and epidemiology or 

statistics. 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-officio 

members. 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/ 

pulmonary-allergy-drugs-advisorycommittee/pulmonary-allergy-advisorycommittee-charter 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 https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12370 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–0008] 

Advisory Committee; 

Psychopharmacologic Drugs 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 Psychopharmacologic 

Drugs 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 

Psychopharmacologic Drugs Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

June 4, 2024, expiration date. 

DATES: Authority for the 

Psychopharmacologic Drugs Advisory 

Committee will expire on June 4, 2024, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Frimpong, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 301– 

796–9001, email: PDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Psychopharmacologic 

Drugs 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 

data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the practice of psychiatry and 

related fields and make appropriate 

recommendations to the Commissioner. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

psychopharmacology, psychiatry, 

epidemiology or statistics, and related 

specialties. 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34879 

information can be found at https://

www.fda.gov/advisory-committees/ 

psychopharmacologic-drugs-advisorycommittee/psychopharmacologic-drugsadvisory-committee-charter 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 https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12366 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–2013–N–1425] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mitigation 

Strategies To Protect Food Against 

Intentional Adulteration 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by July 8, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0812. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Mitigation Strategies To Protect Food 

Against Intentional Adulteration—21 

CFR Part 121 

OMB Control Number 0910–0812— 

Extension 

Under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) certain 

provisions protect against the 

intentional adulteration of food. Section 

418 of the FD&C Act (21 U.S.C. 350g) 

addresses intentional adulteration in the 

context of facilities that manufacture, 

process, pack, or hold food and are 

required to register under section 415 of 

the FD&C Act (21 U.S.C. 350d). Section 

419 of the FD&C Act (21 U.S.C. 350h) 

addresses intentional adulteration in the 

context of fruits and vegetables that are 

raw agricultural commodities. Section 

420 of the FD&C Act (21 U.S.C. 350i) 

addresses intentional adulteration in the 

context of high-risk foods and exempts 

farms except for farms that produce 

milk. These provisions are codified at 

21 CFR part 121 (part 121) and include 

requirements that an owner, operator, or 

agent in charge of a facility must: 

• Prepare and implement a written 

food defense plan that includes a 

vulnerability assessment to identify 

significant vulnerabilities and 

actionable process steps, mitigation 

strategies, and procedures for food 

defense monitoring, corrective actions, 

and verification (§ 121.126); 

• identify any significant 

vulnerabilities and actionable process 

steps by conducting a vulnerability 

assessment for each type of food 

manufactured, processed, packed, or 

held at the facility using appropriate 

methods to evaluate each point, step, or 

procedure in a food operation 

(§ 121.130); 

• identify and implement mitigation 

strategies at each actionable process step 

to provide assurances that the 

significant vulnerability at each step 

will be significantly minimized or 

prevented and the food manufactured, 

processed, packed, or held by the 

facility will not be adulterated. For each 

mitigation strategy implemented at each 

actionable process step, include a 

written explanation of how the 

mitigation strategy sufficiently 

minimizes or prevents the significant 

vulnerability associated with the 

actionable process step (§ 121.135); 

• establish and implement mitigation 

strategies management components, as 

appropriate to ensure the proper 

implementation of each such mitigation 

strategy, taking into account the nature 

of the mitigation strategy and its role in 

the facility’s food defense system 

(§ 121.138); 

• establish and implement food 

defense monitoring procedures, for 

monitoring the mitigation strategies, as 

appropriate to the nature of the 

mitigation strategy and its role in the 

facility’s food defense system 

(§ 121.140); 

• establish and implement food 

defense corrective action procedures 

that must be taken if mitigation 

strategies are not properly implemented, 

as appropriate to the nature of the 

actionable process step and the nature 

of the mitigation strategy (§ 121.145); 

• establish and implement specified 

food defense verification activities, as 

appropriate to the nature of the 

mitigation strategy and its role in the 

facility’s food defense system 

(§ 121.150); 

• conduct a reanalysis of the food 

defense plan (§ 121.157); 

• ensure that all individuals who 

perform required food defense activities 

are qualified to perform their assigned 

duties (§ 121.4); and 

• establish and maintain certain 

records, including the written food 

defense plan (vulnerability assessment, 

mitigation strategies and procedures for 

food defense monitoring, corrective 

actions, and verification) and 

documentation related to training of 

personnel. All records are subject to 

certain general recordkeeping and 

record retention requirements 

(§§ 121.301 through 121.330). 

Under the regulations, an owner, 

operator, or agent in charge of a facility 

must prepare, or have prepared, and 

implement a written food defense plan, 

including written identification of 

actionable process steps, written 

mitigation strategies, written procedures 

for defense monitoring, written food 

defense corrective actions, and written 

food defense verification procedures. 

The purpose of the information 

collection is to ensure compliance with 

the provisions under part 121 related to 

protecting food from intentional 

adulteration. The regulations are 

intended to address hazards that may be 

intentionally introduced to foods, 

including by acts of terrorism, with the 

intent to cause widespread harm to 

public health. Under the regulations, 


khammond on DSKJM1Z7X2PROD with NOTICES