83892 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

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: October 10, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24095 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0112] 

Considerations for Long-Term Clinical 

Neurodevelopmental Safety Studies in 

Neonatal Product Development; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Considerations for Long-Term Clinical 

Neurodevelopmental Safety Studies in 

Neonatal Product Development; 

Guidance for Industry.’’ This guidance 

is intended to provide a framework for 

considering whether and what type of 

long-term neurologic, sensory, and 

developmental evaluations could be 

useful in supporting a determination of 

safety of an FDA-regulated ‘‘medical 

product’’ (i.e., drug, biological product, 

or medical device) for use in neonates. 

Although short-term safety evaluations 

may be appropriate for adults or other 

populations, such evaluations may not 

identify important adverse events in the 

neonatal population, as medical 

treatment during the neonatal period 

coincides with a time of critical growth 

and physiologic development and latent 

effects may not be evident until later in 

life following early-life exposures. 

Consideration of the potential for longterm neurologic, sensory, and 

developmental effects in the neonatal 

population early in a development 

program is important for establishing 

safety of a medical product intended for 

use in neonates. This guidance finalizes 

the draft guidance of the same title 

issued on February 13, 2023. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2022–D–0112 for ‘‘Considerations for 

Long-Term Clinical 

Neurodevelopmental Safety Studies in 

Neonatal Product Development; 

Guidance for Industry.’’ Received 

comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; or 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 83893 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: An 

Massaro, Office of Pediatric 

Therapeutics, Office of Clinical Policy 

and Programs, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, 5th Floor, Silver Spring, 

MD 20993–0002, 301–467–8507; Gerri 

Baer, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5399, Silver Spring, 

MD 20993–0002, 240–402–2865; James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 240–402–5923; and Vasum 

Peiris, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Silver Spring, MD 

20993–0002, 301–796–6089. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Considerations for Long-Term Clinical 

Neurodevelopmental Safety Studies in 

Neonatal Product Development; 

Guidance for Industry.’’ 

Treatment with medical products 

during the neonatal period coincides 

with a time of critical growth and 

physiologic development. Although 

short-term safety evaluations may be 

appropriate for adults or other 

populations, such short-term 

evaluations may not identify important 

adverse events in the neonatal 

population, as latent effects may follow 

early-life exposures. Historically, most 

medical products used to treat neonates 

and young infants were not approved 

for use in these populations, and thus 

have not undergone comprehensive 

evaluation of safety or efficacy for use 

in neonates. 

Neonates should have the same access 

as other populations to medical 

products that have been adequately 

evaluated for optimal dosing, efficacy, 

and safety. There are unique conditions 

that occur in term or preterm neonates 

that do not have analogous clinical 

conditions in older populations. As 

products are developed for unique 

neonatal conditions, first-in-human 

studies may occur in neonates, and 

these development programs should 

demonstrate long-term neurologic, 

sensory, and developmental safety. 

Clinical investigators and sponsors of 

neonatal studies should consider both 

the potential short- and long-term 

effects of an investigational therapy, 

whether the therapy has been approved 

for a similar indication in an older 

population or whether being developed 

for a new indication specific to the 

neonatal population. 

This guidance will discuss general, 

patient-specific and product-specific 

considerations that impact the 

evaluation of whether and what type of 

long-term follow-up assessment should 

be considered. Types of follow-up 

assessments, ranging from 

neurodevelopmental screening through 

a comprehensive neurodevelopmental 

evaluation, which domains of 

assessment may be most pertinent, and 

the timing and duration of assessment 

are discussed. 

This guidance finalizes the draft 

guidance entitled ‘‘Considerations for 

Long-Term Clinical 

Neurodevelopmental Safety Studies in 

Neonatal Product Development; 

Guidance for Industry’’ issued on 

February 13, 2023 (88 FR 9296). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include: 

• The background section of the 

guidance addresses the recommended 

minimum duration of follow-up and 

notes that this will depend on different 

population- and product-specific factors 

as discussed throughout the guidance. 

• In the section of the guidance that 

addresses product-specific 

considerations when determining 

whether long-term neurodevelopmental 

safety evaluations should be conducted, 

new text was added about the impact of 

the route of product administration. 

• In the section of the guidance that 

addresses general considerations when 

developing a plan to evaluate long-term 

neurodevelopmental safety, new text 

was added about planning for clinical 

referral. 

• New text was also added to the first 

paragraph of the section of the guidance 

entitled ‘‘What to Measure, When, and 

for How Long’’ that clarifies that the 

protocol should specify whether 

assessments are conducted as part of 

standard clinical care or for researchrelated purposes only. The new text also 

clarifies that for research-related 

interventions, the benefit-risk 

determination should be performed to 

ensure that the procedure is ethically 

permissible. 

In addition, editorial changes were 

made to improve clarity noting that this 

guidance does not address gene therapy 

or genomic medical interventions. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Considerations for 

Long-Term Clinical 

Neurodevelopmental Safety Studies in 

Neonatal Product Development; 

Guidance for Industry.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information for submission of 

investigational new drug applications, 

21 CFR part 312, have been approved 

under 0910–0014. The collections of 

information for submission of new drug 

applications, 21 CFR part 314, have 

been approved under 0910–0001. The 

collections of information for 

submission of biologic license 

applications, 21 CFR part 601, have 

been approved under 0910–0338. The 

collections of information for 

submission of premarket notifications, 

21 CFR part 807, subpart E; 

investigational device exemptions, 21 

CFR part 812; premarket approval 

applications, part 814 (21 CFR part 814), 

subparts A through E; humanitarian 

device exemptions, part 814, subpart H; 

De Novo classification requests, 21 CFR 

part 860, subpart D; and the Qsubmission Program, in FDA’s guidance 

entitled ‘‘Requests for Feedback and 

Meetings for Medical Device 

Submissions: The Q-Submission 

Program,’’ have been approved under 

OMB control numbers 0910–0120, 

0910–0078, 0910–0231, 0910–0332, 

0910–0844, and 0910–0756, 

respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaVerDate Sep<11>2014 16:48 Oct 17, 2024 Jkt 265001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1

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83894 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

guidance-documents, or https://

www.regulations.gov. 

Dated: October 10, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24108 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Migrant Health; Amended 

Notice of Meeting 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice; amended notice of 

meeting. 

SUMMARY: HRSA published a notice in 

the Federal Register of July 23, 2024, 

concerning a meeting of the National 

Advisory Council on Migrant Health on 

October 22, 2024, and October 23, 2024. 

The notice states the meeting will be 

held in-person and via webinar. 

However, due to the impact of recent 

hurricanes on council members, this 

meeting now will be held via webinar 

only on Zoom. 

FOR FURTHER INFORMATION CONTACT: Liz 

Rhee, National Advisory Council on 

Migrant Health Designated Federal 

Official, Office of Policy and Program 

Development, Bureau of Primary Health 

Care, HRSA, 5600 Fishers Lane, 

Rockville, MD 20857; 301–443–1082 or 

hrsabphcoppdnacmh@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Amended Notice of Meeting 

In the Federal Register Notice of July 

23, 2024, FR Doc. 2024–16119, page 

59744, column 1, section 2, paragraph 3, 

amend the sentences ‘‘This meeting will 

be held in-person and via webinar. The 

address of the meeting is 5600 Fishers 

Lane, Rockville, MD 20857’’ to read: 

‘‘This meeting will be held via webinar 

only.’’ In paragraph 8, delete the 

following sentences: ‘‘Since this 

meeting occurs in a federal government 

building, attendees must go through a 

security check to enter the building. 

Non-U.S. citizen attendees must notify 

HRSA of their planned attendance at 

least 20 business days prior to the 

meeting to facilitate their entry into the 

building. All attendees are required to 

present government-issued 

identification prior to entry.’’ 

Amy P. McNulty, 

Deputy Director, Executive Secretariat. 

[FR Doc. 2024–24165 Filed 10–17–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Charter Renewal of the Advisory 

Committee on Blood and Tissue Safety 

and Availability 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services is hereby giving notice 

that the charter for the Advisory 

Committee on Blood and Tissue Safety 

and Availability (ACBTSA) has been 

renewed. 

FOR FURTHER INFORMATION CONTACT: 

James Berger, Designated Federal Officer 

for the ACBTSA; Office of Infectious 

Disease and HIV/AIDS Policy, Office of 

the Assistant Secretary for Health, 

Department of Health and Human 

Services, Tower Building, 1101 Wootton 

Parkway, Rockville, MD 20852. Phone: 

(202) 795–7608. Email: ACBTSA@

hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

ACBTSA is a non-discretionary federal 

advisory committee. The ACBTSA is 

authorized under 42 U.S.C. 217a, 

section 222 of the Public Health Service 

(PHS) Act, as amended. The Committee 

is governed by the provisions of the 

Federal Advisory Committee Act 

(FACA), Public Law 92–463, as 

amended (5 U.S.C. App), which sets 

forth standards for the formation and 

use of advisory committees. The 

ACBTSA advises, assists, consults with, 

and makes policy recommendations to 

the Secretary, through the Assistant 

Secretary for Health, regarding broad 

responsibilities related to the safety of 

blood, blood products, tissues, and 

organs. For solid organs and blood stem 

cells, the Committee’s work is limited to 

policy issues related to donor derived 

infectious disease complications of 

transplantation. 

To carry out its mission, the ACBTSA 

provides advice to the Secretary through 

the Assistant Secretary for Health on a 

range of policy issues which includes: 

(1) identification of public health issues 

through surveillance of blood and tissue 

safety issues with national biovigilance 

data tools; (2) identification of public 

health issues that affect availability of 

blood, blood products, and tissues; (3) 

broad public health, ethical, and legal 

issues related to the safety of blood, 

blood products, and tissues; (4) the 

impact of various economic factors (e.g., 

product cost and supply) on safety and 

availability of blood, blood products, 

and tissues; (5) risk communications 

related to blood transfusion and tissue 

transplantation; and (6) identification of 

infectious disease transmission issues 

for blood, organs, blood stem cells and 

tissues. 

On September 25, 2024, the Secretary 

approved for the ACBTSA charter to be 

renewed. Renewal of the Committee’s 

charter gives authorization for the 

Committee to continue to operate until 

October 9, 2026. 

A copy of the ACBTSA charter is 

available on the Committee’s website at 

https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/charter/index.html. 

Dated: October 3, 2024. 

James J. Berger, 

DFO, Advisory Committee on Blood and 

Tissue Safety and Availability, Office of 

Infectious Disease and HIV/AIDS Policy. 

[FR Doc. 2024–24133 Filed 10–17–24; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health. 

ACTION: Notice. 

SUMMARY: Pursuant to section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP, the full 

meeting agenda, and instructions for 

linking to public access will be posted 

on the SACHRP website at https://

www.hhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

DATES: The meeting will be held on 

Tuesday, October 22, 2024, from 11:00 

a.m. until 4:30 p.m. (times are tentative 

and subject to change). The confirmed 

times and agenda will be posted on the 

SACHRP website as this information 

becomes available. 

ADDRESSES: This meeting will be held 

via webcast. Members of the public may 


khammond on DSKJM1Z7X2PROD with NOTICES