29160 Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Notices 

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL

SAFEGUARDS: 

Paper records are maintained in 

locked file storage areas or in specified 

areas to which only authorized 

personnel have access. Electronic 

records are protected from unauthorized 

access through password identification 

procedures, limited access, firewalls, 

and other system-based protection 

methods. 

RECORD ACCESS PROCEDURES: 

Individuals requesting access to this 

system of records must follow the 

procedures set forth in OGE’s Privacy 

Act regulations at 5 CFR part 2606. 

CONTESTING RECORD PROCEDURES: 

Individuals wishing to request 

amendment of records about themselves 

should contact the System Manager. 

Individuals must furnish the following 

information for their records to be 

located and identified: 

a. Full name. 

b. Social Security Number. 

c. Dates of employment. 

Individuals requesting amendment 

must also follow OGE’s Privacy Act 

regulations regarding verification of 

identity and amendment of records (5 

CFR part 2606). 

NOTIFICATION PROCEDURES: 

Individuals wishing to inquire 

whether this system of records contains 

information about themselves must 

follow the procedures set forth in OGE’s 

Privacy Act regulations at 5 CFR part 

2606. 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

None. 

HISTORY: 

86 FR 62537. 

Approved: May 9, 2022. 

Emory Rounds, 

Director, U.S. Office of Government Ethics. 

[FR Doc. 2022–10190 Filed 5–11–22; 8:45 am] 

BILLING CODE 6345–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Solicitation of Nominations for 

Appointment to CDC’s Advisory 

Committee to the Director (ACD) 

Laboratory Workgroup (LW); Amended 

Notice 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Amended notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) gives 

notice of a change in the solicitation of 

CDC’s Advisory Committee to the 

Director (ACD) Laboratory Workgroup 

(LW), in the original FRN published on 

May 4, 2022. The request for 

nominations is being amended to 

update the language in the 

supplementary information section of 

the notice, restated below. 

DATES: Nominations for membership on 

the LW workgroup must be received no 

later than May 16, 2022. Late 

nominations will not be considered for 

membership. 

ADDRESSES: All nominations (cover 

letters and curriculum vitae) should be 

emailed to LWACD@cdc.gov with the 

subject line: ‘‘Nomination for CDC ACD 

LW Workgroup.’’ 

FOR FURTHER INFORMATION CONTACT: 

Lauren Hoffmann, MA, Office of the 

Chief of Staff, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE, Mailstop H21–10, Atlanta, 

Georgia 30329–4027; Telephone: (404) 

639–7000; Email: LWACD@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The purpose of the ACD, 

CDC is to advise the Secretary, HHS, 

and the Director, CDC, on policy and 

broad strategies that will enable CDC to 

fulfill its mission of protecting health 

through health promotion, prevention, 

and preparedness. The ACD, CDC 

consists of up to 15 non-federal 

members, including the Chair, 

knowledgeable in areas pertinent to the 

CDC mission, such as health policy, 

public health, global health, 

preparedness, preventive medicine, the 

faith-based and community-based 

sector, and allied fields. The request for 

nominations in the original published 

FRN was published in the Federal 

Register on May 4, 2022, Volume 87, 

Number 86, page 26358. 

Purpose: The establishment and 

formation of the LW is to provide input 

to the ACD, CDC on agency-wide 

activities related to laboratory quality 

management, continuous laboratory 

quality improvement, and laboratory 

diagnostic testing to support public 

health programs and investigations. The 

LW membership will consist of up to 15 

members. It will be co-chaired by two 

current ACD, CDC Special Government 

Employees. The LW co-chairs will 

present their findings, observations, and 

work products at one or more ACD, CDC 

meetings for discussion, deliberation, 

and decisions (final recommendations 

to CDC). 

Nomination Criteria: LW members 

will serve terms ranging from six 

months to one year and be required to 

attend LW meetings approximately 1–2 

times per month (virtually or in person), 

and contribute time between meetings 

for research, consultation, discussion, 

and writing assignments. 

Nominations are being sought for 

individuals who have the expertise and 

qualifications necessary to contribute to 

the accomplishments of the 

committee’s/workgroup’s objectives. 

Nominees will be selected based on 

expertise in the fields of public health 

laboratory science and practice, 

laboratory quality management, 

diagnostic regulations, and clinical 

laboratory testing and research. To 

ensure a diverse workgroup 

composition, nominees with front line 

and field experience at the local, state, 

tribal, and territorial levels are 

encouraged to apply. Federal employees 

will not be considered for membership. 

Selection of members is based on 

candidates’ qualifications to contribute 

to the accomplishment of the LW’s 

objectives. 

HHS policy stipulates that 

membership be balanced in terms of 

points of view represented and the 

workgroup’s function. Appointments 

shall be made without discrimination 

based on age, race, ethnicity, gender, 

sexual orientation, gender identity, HIV 

status, disability, and cultural, religious, 

or socioeconomic status. Nominees 

cannot be full-time employees of the 

U.S. Government. Current participation 

on federal workgroups or prior 

experience serving on a federal advisory 

committee does not disqualify a 

candidate; however, HHS policy is to 

avoid excessive individual service on 

advisory committees and multiple 

committee memberships. Interested 

candidates should submit the following 

items: 

D A one-half to one-page cover letter 

that includes your understanding of, 

and commitment to, the time and work 

necessary; one to two sentences on your 

background and experience; and one to 

two sentences on the skills/perspective 

you would bring to the LW. 

D Current curriculum vitae which 

highlights the experience and work 

history being sought relevant to the 

criteria set forth above, including 

complete contact information 

(telephone numbers, mailing address, 

email address). 

Nominations may be submitted by the 

candidate him or herself, or by the 

person/organization recommending the 

candidate no later than May 16, 2022. 

All nominations (cover letters and 

curriculum vitae) should be emailed to 

LWACD@cdc.gov with the subject line: 

‘‘Nomination for CDC ACD LW 

Workgroup.’’ 


khammond on DSKJM1Z7X2PROD with NOTICES
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