78316 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biological product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, ELUCIREM 

(gadopiclenol) indicated in adult and 

pediatric patients aged 2 years and older 

for use with magnetic resonance 

imaging to detect and visualize lesions 

with abnormal vascularity in: the 

central nervous system (brain, spine, 

and associated tissues), the body (head 

and neck, thorax, abdomen, pelvis and 

musculoskeletal system). Subsequent to 

this approval, the USPTO received a 

patent term restoration application for 

ELUCIREM (U.S. Patent No. 8,114,863) 

from Guerbet LLC and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

October 19, 2023, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

ELUCIREM represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

ELUCIREM is 2,443 days. Of this time, 

2,199 days occurred during the testing 

phase of the regulatory review period, 

while 244 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: January 15, 

2016. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on January 15, 2016. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: January 21, 2022. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

ELUCIREM (NDA 216986) was initially 

submitted on January 21, 2022. 

3. The date the application was 

approved: September 21, 2022. FDA has 

verified the applicant’s claim that NDA 

216986 was approved on September 21, 

2022. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,344 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21929 Filed 9–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4392] 

Live Biotherapeutic Products To 

Prevent Necrotizing Enterocolitis in 

Very Low Birth Weight Infants; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency), the 

Centers for Disease Control and 

Prevention (CDC), the National 

Institutes of Health (NIH), the National 

Institute of Allergy and Infectious 

Diseases (NIAID), and the Eunice 

Kennedy Shriver National Institute of 

Child Health and Human Development 

(NICHD) (collectively, we) are 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78317 

announcing a public workshop entitled 

‘‘Live Biotherapeutic Products to 

Prevent Necrotizing Enterocolitis in 

Very Low Birth Weight Infants.’’ The 

purpose of the public workshop is to 

exchange information with the medical 

and scientific community about the 

regulatory and scientific issues 

associated with use of live 

biotherapeutic products to prevent 

necrotizing enterocolitis (NEC) in very 

low birth weight (VLBW) infants. 

DATES: The public workshop will be 

held on October 25, 2024, from 9 a.m. 

to 4 p.m. Eastern Time. Either electronic 

or written comments on this public 

workshop must be submitted by 

November 25, 2024. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at the NIH, National Institute of 

Allergy and Infectious Diseases 

Building, 5601 Fishers Lane, Rockville, 

MD 20892. Entrance for public 

workshop participants (non-NIH 

employees) is through the NIAID 

Building front lobby entrance where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.niaid.nih.gov/about/visitorinformation. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 25, 2024. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received 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– 

2024–N–4392 for ‘‘Live Biotherapeutic 

Products to Prevent Necrotizing 

Enterocolitis in Very Low Birth Weight 

Infants.’’ 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: 

Ryan Ranallo, National Institute of 

Allergy and Infectious Diseases, 

Division of Microbiology and Infectious 

Diseases, National Institutes of Health, 

5601 Fishers Lane, Rockville, MD 

20852, 240–479–1958, ryan.ranallo@

nih.gov; or Peter Weina, Office of 

Vaccines Research and Review, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 202–740–8687. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Necrotizing enterocolitis (NEC) in 

very low birth weight infants (VLBW) 

remains a significant public health 

problem. FDA has not approved any 

products, including live biotherapeutic 

products, for the prevention of NEC. 

Various products marketed as probiotics 

have been used in efforts to prevent this 

serious and life-threatening outcome; 

however, substantial evidence of 

effectiveness has not been demonstrated 

and serious adverse outcomes, 

including death, have been reported 

following use of probiotics in preterm 

infants. 

II. Topics for Discussion at the Public 

Workshop 

This public workshop is convened to: 

(1) advance a shared understanding of 

the epidemiology of NEC; (2) review 

current feeding practices; (3) discuss 

limitations of NEC case definitions; (4) 

review dynamics of the microbiome and 

NEC pathogenesis; (5) discuss the state 

of the evidence for probiotic use to 

prevent NEC; (6) review safety signals 

with probiotics; (7) explore clinical trial 

considerations; and (8) discuss 

challenges and opportunities in 

advancing development of Live 

Biotherapeutic Products as safe and 

effective products for the prevention of 

NEC in VLBW infants. 


ddrumheller on DSK120RN23PROD with NOTICES1
78318 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website for registration information: 

https://cvent.me/9NerMP. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop inperson must register by October 11, 

2024, 11:59 p.m. Eastern Time. Early 

registration is recommended because inperson seating is limited; therefore, we 

may limit the number of participants 

from each organization. 

If you need special accommodations 

due to a disability, please contact Ms. 

Christina McCormick, 

christina.mccormick@nih.gov, no later 

than October 15, 2024. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the public comment session. 

Following the close of registration, we 

will determine the amount of time 

allotted to each presenter and the 

approximate time each oral presentation 

is to begin and will select and notify 

participants by October 18, 2024. All 

requests to make oral presentations 

must be received by the close of 

registration on October 11, 2024, at 

11:59 p.m. Eastern Time. If selected for 

presentation, any presentation materials 

must be emailed to Ryan Ranallo 

(ryan.ranallo@nih.gov) no later than 

October 22, 2024. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast on https://videocast.

nih.gov/. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

Recording: Please be advised that as 

soon as possible after a recording of the 

public workshop is available, it will be 

accessible at https://videocast.nih.gov/ 

PastEvents and available until October 

25, 2025. 

Notice of this meeting is given 

pursuant to 21 CFR 10.65. 

Dated: September 20, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21928 Filed 9–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Integrative Health; Notice of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council for Complementary and 

Integrative Health. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. The open 

session can also be accessed at the 

following NIH Videocast URL link 

https://videocast.nih.gov. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Complementary and Integrative 

Health. 

Date: January 24, 2025. 

Closed: 10:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, DEM 2, 

6707 Democracy Boulevard, Bethesda, MD 

20892, Virtual Meeting. 

Open: 12:30 p.m. to 4:00 p.m. 

Agenda: Reports and Updates about Recent 

and Ongoing NCCIH Led or Involved 

Activities by NCCIH staff and its Director. 

Place: National Institutes of Health, DEM 2, 

6707 Democracy Boulevard, Bethesda, MD 

20892, Virtual Meeting. 

Contact Person: Martina Schmidt, Ph.D., 

Director, Division of Extramural Activities, 

National Center for Complementary & 

Integrative Health, NIH, 6707 Democracy 

Blvd., Suite 401, Bethesda, MD 20892, (301) 

594–3456, schmidma@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should be less than 

700 words in length, and should include the 

name, email address, telephone number and 

when applicable, the business or professional 

affiliation of the interested person. Any 

member of the public may submit written 

comments no later than January 10th, 2024 

(14 days before the council meeting). 

Information is also available on the 

Institute’s/Center’s home page: https://

nccih.nih.gov/about/naccih, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: September 19, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21858 Filed 9–24–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIDA– 

K Alternate SEP. 

Date: November 4, 2024. 

Time: 3:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Marisa Srivareerat, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Office of Extramural Policy, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 435–1258, 

marisa.srivareerat@nih.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1