29162 Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Notices 

progress in implementing resource 

capacity planning and modernized time 

reporting. This meeting is intended to 

satisfy FDA’s commitment to host an 

annual public meeting in the third 

quarter of each fiscal year beginning in 

FY 2019 and can be found in the 

Commitment Letters listed below 

(sections II.B.3 of PDUFA VI (p. 38), 

IV.B.3 of BsUFA II (p. 29), and VI.B.4 of 

GDUFA II (p.22)). 

This public meeting is intended to 

meet performance commitments 

included in the respective Commitment 

Letters for PDUFA VI, BsUFA II, and 

GDUFA II. These user fee programs 

were reauthorized as part of the FDA 

Reauthorization Act of 2017 signed by 

the President on August 18, 2017. The 

complete set of performance goals for 

each program are available at: 

• PDUFA VI program: https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf 

• BsUFA II program: https://

www.fda.gov/downloads/forindustry/ 

userfees/biosimilaruserfeeactbsufa/ 

ucm521121.pdf 

• GDUFA II program: https://

www.fda.gov/downloads/forindustry/ 

userfees/genericdruguserfees/ 

ucm525234.pdf 

Each of these user fee programs’ 

Commitment Letters included a set of 

commitments related to financial 

management. These included 

commitments to publish a 5-year 

financial plan and update that plan 

annually, develop resource capacity 

planning capability and modernize time 

reporting practices, and have a thirdparty evaluation of resource 

management practices for these user fee 

programs. In addition, each user fee 

program includes a commitment to host 

a public meeting in the third quarter of 

each fiscal year, beginning in FY 2019, 

to discuss specific topics. 

II. Topics for Discussion at the Public 

Meeting 

This meeting will provide FDA the 

opportunity to update interested public 

stakeholders on topics related to the 

financial management of PDUFA VI, 

BsUFA II, and GDUFA II. These topics 

include the 5-year financial plans for 

each of these programs and FDA’s 

progress towards implementing resource 

capacity planning and modernizing its 

time reporting approach. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://fda.zoomgov.com/ 

webinar/register/WN_

C5cXHj38R6WeNg1ZuqbKaA. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Persons interested in attending this 

public meeting must register by June 2, 

2022, at 11:59 p.m. Eastern Time. We 

will let registrants know if registration 

closes before the day of the public 

meeting. 

If you need special accommodations 

due to a disability, please contact 

Monica Ellerbe at Monica.Ellerbe@

fda.hhs.gov by June 2, 2022, at 11:59 

p.m. Eastern Time. 

Streaming Webcast of the Public 

Meeting: This public meeting will be a 

webcast. To register for the public 

meeting and obtain the webcast 

information, please visit the following 

website: https://fda.zoomgov.com/ 

webinar/register/WN_

C5cXHj38R6WeNg1ZuqbKaA. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Dated: May 6, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10131 Filed 5–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

Advisory Committee for Women’s 

Services (ACWS) Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given of a meeting of 

the Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Advisory Committee for Women’s 

Services (ACWS) on June 14, 2022. 

The meeting will include discussions 

on assessing SAMHSA’s current 

strategies, including the mental health 

and substance use needs of the women 

and girls population. Additionally, the 

ACWS will be addressing priorities 

regarding the impact of COVID–19 on 

the behavioral health needs of women 

and children and directions around 

behavioral health services and access for 

women and children. 

The meeting is open to the public and 

will be held virtually. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Oral presentations 

from the public will be scheduled at the 

conclusion of the meeting. Individuals 

interested in sending written 

submissions or in making oral 

presentations should forward them to 

the contact person by 4:00 p.m. (EDT) 

May 27, 2022. Up to five minutes will 

be allotted for each presentation. 

The meeting may be accessed via 

telephone or web meeting. To obtain the 

call-in number and access code, submit 

written or brief oral comments, or 

request special accommodations for 

persons with disabilities, please register 

on-line at: https://www.samhsa.gov/ 

about-us/advisory-councils or 

communicate with SAMHSA’s 

Designated Federal Officer, Ms. Valerie 

Kolick. 

Substantive meeting information and 

a roster of ACWS members may be 

obtained either by accessing the 

SAMHSA Committees’ Web, https://

www.samhsa.gov/about-us/advisorycouncils/acws or by contacting Ms. 

Kolick. 

Committee Name: Substance Abuse and 

Mental Health Services Administration 

Advisory Committee for Women’s Services 

(ACWS). 

Date/Time/Type: Tuesday, June 14, 2022, 

from: 12:30 p.m. to 4:30 p.m. EDT/(OPEN). 

Place: SAMHSA, 5600 Fishers Lane, 

Rockville, MD 20857 (Virtual). 

Contact: Valerie Kolick, Designated Federal 

Officer, SAMHSA’s Advisory Committee for 

Women’s Services, 5600 Fishers Lane, 

Rockville, MD 20857, Telephone: (240) 276– 

1738, Email: Valerie.kolick@samhsa.hhs.gov. 

Dated: May 5, 2022. 

Carlos Castillo, 

CAPT, USPHS, Committee Management 

Officer, Substance Abuse and Mental Health 

Services Administration. 

[FR Doc. 2022–10158 Filed 5–11–22; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–4634– 

DR; Docket ID FEMA–2022–0001] 

Colorado; Amendment No. 4 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

State of Colorado (FEMA–4634–DR), 

dated December 31, 2021, and related 

determinations. 


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