Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Notices 29161 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–10142 Filed 5–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–1875] 

Financial Transparency and Efficiency 

of the Prescription Drug User Fee Act, 

Biosimilar User Fee Act, and Generic 

Drug User Fee Amendments; Public 

Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Financial 

Transparency and Efficiency of the 

Prescription Drug User Fee Act, 

Biosimilar User Fee Act, and Generic 

Drug User Fee Amendments.’’ The topic 

to be discussed is the financial 

transparency and efficiency of the 

Prescription Drug User Fee Act, 

Biosimilar User Fee Act, and Generic 

Drug User Fee Amendments. 

DATES: The public meeting will be held 

on June 7, 2022, from 9:30 a.m. to 10:50 

a.m. via ZoomGov. Submit either 

electronic or written comments on this 

public meeting by July 7, 2022. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held virtually due to extenuating 

circumstances. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before July 7, 2022. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

July 7, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–N–1875 for ‘‘Financial 

Transparency and Efficiency of the 

Prescription Drug User Fee Act, 

Biosimilar User Fee Act, and Generic 

Drug User Fee Amendments; Public 

Meeting; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Monica Ellerbe, Office of Finance, 

Budget, Acquisition, and Planning, 4041 

Powder Mill Rd., Rm. 72044, Beltsville, 

MD 20750, 301–796–5276, 

Monica.Ellerbe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The meeting will include 

presentations from FDA on topics 

related to the financial management of 

certain user fee programs, including 

presentations on the following: (1) The 

5-year financial plan for the Prescription 

Drug User Fee Act (PDUFA) VI, 

Biosimilar User Fee Act (BsUFA) II, and 

Generic Drug User Fee Amendments 

(GDUFA) II and (2) the Agency’s 


khammond on DSKJM1Z7X2PROD with NOTICES
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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