324 Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices 

115–52) was signed into law, which 

outlined additional requirements to be 

included in the report. 

II. Topics for Discussion at the Public 

Meeting 

Some of the issues to be discussed at 

the meeting will include, but not be 

limited to: 

• Hearing from patients/parents/ 

caregivers and patient/parent/caregiver 

groups, consumer groups, industry, 

academia, and other interested parties 

about the public health impact that the 

pediatric legislation may have had on 

them or their communities, including 

treatment advances for children 

resulting from the legislation, as well as 

areas of continued unmet medical need. 

• Understanding the effects of the 

requirement of pediatric studies under 

PREA or the incentives under BPCA on 

drug/biologic development plans, 

including issues related to the balance 

of incentives and requirements and 

progress toward international alignment 

on pediatric drug development to the 

extent practicable. 

• Understanding if there are any 

barriers or resource issues preventing 

undertaking or completing studies 

under PREA and BPCA, including 

issues related to clinical trial 

infrastructure and enrollment and 

ensuring pediatric clinical trial 

populations reflect the diversity of 

children most likely to use and benefit 

from the therapeutic treatments. 

• Understanding successes and 

challenges with leveraging scientific 

advances in product development, 

including, but not limited to, use of 

pediatric extrapolation, adaptive trial 

designs, biomarkers as surrogates, and 

real-world data to facilitate more timely 

evidence-generation for pediatric 

populations. 

III. Participating in the Public Meeting 

Registration: For more information 

and to register for the public meeting, 

please visit: https://www.fda.gov/newsevents/fda-meetings-conferences-andworkshops/interested-parties-meetingimplementation-best-pharmaceuticalschildren-act-and-pediatric-research. 

Please provide complete contact 

information for each attendee, including 

name, email address, and affiliation. 

Registration is free and based on space 

availability for in-person attendance, 

with priority given to early registrants. 

Persons interested in attending this 

public meeting in-person must register 

by May 1, 2025, 11:59 p.m. Eastern 

Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 8 a.m. We will post a 

notice on the meeting web page if 

registration for in-person attendance 

closes before the day of the public 

meeting. 

If you need special accommodations 

due to a disability, please contact OPT@

fda.hhs.gov no later than May 8, 2025, 

11:59 p.m. Eastern Time. 

Requests for Oral Comment: During 

online registration you may indicate if 

you wish to present an oral comment 

during a public comment session, and 

which topic(s) you wish to address. We 

will do our best to accommodate 

requests to make oral comments. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

comments. All requests to make oral 

comments, for both virtual and inperson attendees, must be received by 

the close of in-person registration on 

May 1, 2025, 11:59 p.m. Eastern Time. 

Following the close of registration, we 

will determine the amount of time 

allotted to each presenter and the 

approximate time that the oral comment 

session is to begin, and will notify 

participants making an oral comment by 

May 5, 2025, 11:59 p.m. Eastern Time. 

If making an oral comment, any 

presentation materials must be emailed 

to OPT@fda.hhs.gov (see FOR FURTHER

INFORMATION CONTACT) no later than May 

9, 2025, 11:59 p.m. Eastern Time. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. The link to view the virtual 

Zoom webinar will be sent to registered 

participants prior to the meeting. The 

meeting web page link is: https://

www.fda.gov/news-events/fda-meetingsconferences-and-workshops/interestedparties-meeting-implementation-bestpharmaceuticals-children-act-andpediatric-research. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

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, https://

www.fda.gov/news-events/fda-meetingsconferences-and-workshops/interestedparties-meeting-implementation-bestpharmaceuticals-children-act-andpediatric-research, or the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 9 

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

Friday, 240–402–7500. 

Notice of this meeting is given 

pursuant to 21 CFR 10.65. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31312 Filed 1–2–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine and Oral 

Fluid Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines) using 

Urine and the laboratories currently 

certified to meet the standards of the 

Mandatory Guidelines using Oral Fluid. 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Flanagan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Flanagan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) publishes a notice 

listing all HHS-certified laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) in the Federal Register during 

the first week of each month, in 

accordance with Section 9.19 of the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

Section 9.17 of the Mandatory 

Guidelines using Oral Fluid. If any 

laboratory or IITF certification is 

suspended or revoked, the laboratory or 

IITF will be omitted from subsequent 

lists until such time as it is restored to 

full certification under the Mandatory 

Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices 325 

at the end and will be omitted from the 

monthly listing thereafter. 

This notice is also available on the 

internet at https://www.samhsa.gov/ 

workplace/drug-testing-resources/ 

certified-lab-list. 

HHS separately notifies Federal 

agencies of the laboratories and IITFs 

currently certified to meet the standards 

of the Mandatory Guidelines using 

Urine and of the laboratories currently 

certified to meet the standards of the 

Mandatory Guidelines using Oral Fluid. 

The Mandatory Guidelines using 

Urine were first published in the 

Federal Register on April 11, 1988 (53 

FR 11970), and subsequently revised in 

the Federal Register on June 9, 1994 (59 

FR 29908); September 30, 1997 (62 FR 

51118); April 13, 2004 (69 FR 19644); 

November 25, 2008 (73 FR 71858); 

December 10, 2008 (73 FR 75122); April 

30, 2010 (75 FR 22809); January 23, 

2017 (82 FR 7920); and on October 12, 

2023 (88 FR 70768). 

The Mandatory Guidelines using Oral 

Fluid were first published in the 

Federal Register on October 25, 2019 

(84 FR 57554) with an effective date of 

January 1, 2020, and subsequently 

revised in the Federal Register on 

October 12, 2023 (88 FR 70814). 

The Mandatory Guidelines were 

initially developed in accordance with 

Executive Order 12564 and section 503 

of Public Law 100–71 and allowed urine 

drug testing only. The Mandatory 

Guidelines using Urine have since been 

revised, and new Mandatory Guidelines 

allowing for oral fluid drug testing have 

been published. The Mandatory 

Guidelines require strict standards that 

laboratories and IITFs must meet in 

order to conduct drug and specimen 

validity tests on specimens for Federal 

agencies. HHS does not allow IITFs to 

conduct oral fluid testing. 

To become certified, an applicant 

laboratory or IITF must undergo three 

rounds of performance testing plus an 

on-site inspection. To maintain that 

certification, a laboratory or IITF must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories and IITFs in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines using Urine and/ 

or Oral Fluid. An HHS-certified 

laboratory or IITF must have its letter of 

certification from HHS/SAMHSA 

(formerly: HHS/NIDA), which attests 

that the test facility has met minimum 

standards. HHS does not allow IITFs to 

conduct oral fluid testing. 

HHS-Certified Laboratories Approved 

To Conduct Oral Fluid Drug Testing 

In accordance with the Mandatory 

Guidelines using Oral Fluid effective 

October 10, 2023 (88 FR 70814), the 

following HHS-certified laboratories 

meet the minimum standards to conduct 

drug and specimen validity tests on oral 

fluid specimens: 

At this time, there are no laboratories 

certified to conduct drug and specimen 

validity tests on oral fluid specimens. 

HHS-Certified Instrumented Initial 

Testing Facilities Approved To Conduct 

Urine Drug Testing 

In accordance with the Mandatory 

Guidelines using Urine effective 

February 1, 2024 (88 FR 70768), the 

following HHS-certified IITFs meet the 

minimum standards to conduct drug 

and specimen validity tests on urine 

specimens: 

Dynacare*, 6628 50th Street NW, 

Edmonton, AB Canada T6B 2N7, 780– 

784–1190, (Formerly: GammaDynacare Medical Laboratories) 

HHS-Certified Laboratories Approved 

To Conduct Urine Drug Testing 

In accordance with the Mandatory 

Guidelines using Urine effective 

February 1, 2024 (88 FR 70768), the 

following HHS-certified laboratories 

meet the minimum standards to conduct 

drug and specimen validity tests on 

urine specimens: 

Alere Toxicology Services, 1111 Newton 

St., Gretna, LA 70053, 504–361–8989/ 

800–433–3823, (Formerly: Kroll 

Laboratory Specialists, Inc., 

Laboratory Specialists, Inc.) 

Alere Toxicology Services, 450 

Southlake Blvd., Richmond, VA 

23236, 804–378–9130, (Formerly: 

Kroll Laboratory Specialists, Inc., 

Scientific Testing Laboratories, Inc.; 

Kroll Scientific Testing Laboratories, 

Inc.) 

Clinical Reference Laboratory, Inc., 8433 

Quivira Road, Lenexa, KS 66215– 

2802, 800–445–6917 

Desert Tox, LLC, 5425 E Bell Rd, Suite 

125, Scottsdale, AZ, 85254, 602–457– 

5411/623–748–5045 

DrugScan, Inc., 200 Precision Road, 

Suite 200, Horsham, PA 19044, 800– 

235–4890 

Dynacare*, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4, 519– 

679–1630, (Formerly: GammaDynacare Medical Laboratories) 

ElSohly Laboratories, Inc., 5 Industrial 

Park Drive, Oxford, MS 38655, 662– 

236–2609 

LabOne, Inc. d/b/a Quest Diagnostics, 

10101 Renner Blvd., Lenexa, KS 

66219, 913–888–3927/800–873–8845, 

(Formerly: Quest Diagnostics 

Incorporated; LabOne, Inc.; Center for 

Laboratory Services, a Division of 

LabOne, Inc.) 

Laboratory Corporation of America 

Holdings, 7207 N. Gessner Road, 

Houston, TX 77040, 713–856–8288/ 

800–800–2387 

Laboratory Corporation of America 

Holdings, 69 First Ave., Raritan, NJ 

08869, 908–526–2400/800–437–4986, 

(Formerly: Roche Biomedical 

Laboratories, Inc.) 

Laboratory Corporation of America 

Holdings, 1904 TW Alexander Drive, 

Research Triangle Park, NC 27709, 

919–572–6900/800–833–3984, 

(Formerly: LabCorp Occupational 

Testing Services, Inc., CompuChem 

Laboratories, Inc.; CompuChem 

Laboratories, Inc., A Subsidiary of 

Roche Biomedical Laboratory; Roche 

CompuChem Laboratories, Inc., A 

Member of the Roche Group) 

Laboratory Corporation of America 

Holdings, 1120 Main Street, 

Southaven, MS 38671, 866–827–8042/ 

800–233–6339, (Formerly: LabCorp 

Occupational Testing Services, Inc.; 

MedExpress/National Laboratory 

Center) 

MedTox Laboratories, Inc., 402 W. 

County Road D, St. Paul, MN 55112, 

651–636–7466/800–832–3244 

Minneapolis Veterans Affairs Medical 

Center, Forensic Toxicology 

Laboratory, 1 Veterans Drive, 

Minneapolis, MN 55417, 612–725– 

2088, Testing for Veterans Affairs 

(VA) Employees Only 

Omega Laboratories, Inc.*, 2150 

Dunwin Drive, Unit 1 & 2, 

Mississauga, ON, Canada L5L 5M8, 

289–919–3188 

Pacific Toxicology Laboratories, 9348 

DeSoto Ave., Chatsworth, CA 91311, 

800–328–6942, (Formerly: Centinela 

Hospital Airport Toxicology 

Laboratory) 

Phamatech, Inc., 15175 Innovation 

Drive, San Diego, CA 92128, 888– 

635–5840 

US Army Forensic Toxicology Drug 

Testing Laboratory, 2490 Wilson St., 

Fort George G. Meade, MD 20755– 

5235, 301–677–7085, Testing for 

Department of Defense (DoD) 

Employees Only 

The following laboratory is 

voluntarily withdrawing from the 

National Laboratory Certification 

Program effective January 10, 2025: 

Laboratory Corporation of America, 

1225 NE 2nd Ave., Portland, OR 

97323, 503–413–5295/800–950–5295, 

(Formerly: Legacy Laboratory Services 

Toxicology MetroLab) 

*The Standards Council of Canada 

(SCC) voted to end its Laboratory 


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326 Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices 

Accreditation Program for Substance 

Abuse (LAPSA) effective May 12, 1998. 

Laboratories certified through that 

program were accredited to conduct 

forensic urine drug testing as required 

by U.S. Department of Transportation 

(DOT) regulations. As of that date, the 

certification of those accredited 

Canadian laboratories continued under 

DOT authority. The responsibility for 

conducting quarterly performance 

testing plus periodic on-site inspections 

of those LAPSA-accredited laboratories 

was transferred to the U.S. HHS, with 

the HHS’ NLCP contractor continuing to 

have an active role in the performance 

testing and laboratory inspection 

processes. Other Canadian laboratories 

wishing to be considered for the NLCP 

may apply directly to the NLCP 

contractor just as U.S. laboratories do. 

Upon finding a Canadian laboratory to 

be qualified, HHS will recommend that 

DOT certify the laboratory as meeting 

the minimum standards of the current 

Mandatory Guidelines published in the 

Federal Register. After receiving DOT 

certification, the laboratory will be 

included in the monthly list of HHScertified laboratories and participate in 

the NLCP certification maintenance 

program. DOT established this process 

in July 1996 (61 FR 37015) to allow 

foreign laboratories to participate in the 

DOT drug testing program. 

Anastasia D. Flanagan, 

Public Health Advisor, Division of Workplace 

Programs. 

[FR Doc. 2024–31499 Filed 1–2–25; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. CISA–2024–0037] 

Request for Comment on the National 

Cyber Incident Response Plan Update 

AGENCY: Cybersecurity and 

Infrastructure Security Agency (CISA), 

Department of Homeland Security 

(DHS). 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: On December 16, 2024, the 

Cybersecurity and Infrastructure 

Security Agency (CISA) published a 

request for comment in the Federal 

Register on a draft National Cyber 

Incident Response Plan (NCIRP) Update, 

which requests feedback on the draft 

update. CISA is extending the public 

comment period for the draft update for 

an additional thirty days through 

February 14, 2025. 

DATES: The comment period for the draft 

update published on December 16, 

2024, at 89 FR 101614 is extended. 

Comments and related materials must 

be submitted on or before February 14, 

2025. 

ADDRESSES: You may submit comments, 

identified by docket number CISA– 

2024–0037, by clicking on the ‘‘Submit 

a Public Comment’’ button above or by 

following the instructions below for 

submitting comments directly via the 

Federal public document portal, at 

https://www.regulations.gov. 

Instructions: All comments received 

must include the agency name and 

docket number CISA–2024–0037. All 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. CISA 

reserves the right to publicly republish 

relevant and unedited comments in 

their entirety that are submitted to the 

docket. Do not include personal 

information such as account numbers, 

social security numbers, or names of 

other individuals. Do not submit 

confidential business information or 

otherwise sensitive or protected 

information. 

Docket: For access to the docket to 

read the draft National Cyber Incident 

Response Plan (NCIRP) Update or 

comments received, go to https://

www.regulations.gov. For convenience, 

CISA has also posted the draft NCIRP 

Update on https://www.cisa.gov/ 

national-cyber-incident-response-planncirp. 

FOR FURTHER INFORMATION CONTACT: 

Technical Content information: Mark 

Peters, 771–212–7125, mark.peters@

cisa.dhs.gov. 

Program information: Michael 

Fogarty, 202–412–8385, 

michael.fogarty@cisa.dhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 16, 2024, CISA published a 

request for comment on the NCIRP 

Update (89 FR 101614). In the draft 

update, CISA addresses changes in the 

cyber threat and operations landscape 

by incorporating feedback and lessons 

learned from stakeholders to make the 

updated NCIRP more fully inclusive 

across non-federal stakeholders—further 

establishing a foundation for continued 

improvement of the nation’s response to 

significant cyber incidents. The request 

for comment provided for a 30-day 

comment period, set to close January 15, 

2025. CISA received multiple requests 

to extend the deadline given the 

holidays occurring during the public 

comment period. Therefore, the 

comment period is now open through 

February 14, 2025. 

This notice is issued under the 

authority of 6 U.S.C. 652, 659, 660, and 

665b. 

Jeffrey E. Greene, 

Executive Assistant Director for 

Cybersecurity, Cybersecurity and 

Infrastructure Security Agency, Department 

of Homeland Security. 

[FR Doc. 2024–31514 Filed 1–2–25; 8:45 am] 

BILLING CODE 9111–LF–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0068] 

Agency Information Collection 

Activities; Extension, Without Change, 

of a Currently Approved Collection: 

Registration for Classification as a 

Refugee 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: 60-Day notice. 

SUMMARY: The Department of Homeland 

Security (DHS), U.S. Citizenship and 

Immigration Services (USCIS) invites 

the general public and other Federal 

agencies to comment upon this 

proposed extension of a currently 

approved collection of information. In 

accordance with the Paperwork 

Reduction Act (PRA) of 1995, the 

information collection notice is 

published in the Federal Register to 

obtain comments regarding the nature of 

the information collection, the 

categories of respondents, the estimated 

burden (i.e., the time, effort, and 

resources used by the respondents to 

respond), the estimated cost to the 

respondent, and the actual information 

collection instruments. 

DATES: Comments are encouraged and 

will be accepted for 60 days until March 

4, 2025. 

ADDRESSES: All submissions received 

must include the OMB Control Number 

1615–0068 in the body of the letter, the 

agency name and Docket ID USCIS– 

2007–0036. Submit comments via the 

Federal eRulemaking Portal website at 

https://www.regulations.gov under eDocket ID number USCIS–2007–0036. 

FOR FURTHER INFORMATION CONTACT: 

USCIS, Office of Policy and Strategy, 

Regulatory Coordination Division, 

Samantha Deshommes, Chief, telephone 

number (240) 721–3000 (This is not a 

toll-free number. Comments are not 

accepted via telephone message). Please 

note contact information provided here 


lotter on DSK11XQN23PROD with NOTICES1