Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 1927 

a notice announcing the availability of 

a draft guidance entitled ‘‘Q5A(R2) Viral 

Safety Evaluation of Biotechnology 

Products Derived from Cell Lines of 

Human or Animal Origin.’’ The notice 

gave interested persons an opportunity 

to submit comments by January 13, 

2023. After consideration of the 

comments received and revisions to the 

guideline, a final draft of the guideline 

was submitted to the ICH Assembly and 

endorsed by the regulatory agencies in 

November 2023. 

This guidance revises and finalizes 

the updates included in the draft 

guidance issued on November 14, 2022. 

Like the draft guidance, the final 

guidance reflects updates in scientific 

advances and regulatory expectations 

since the publication of the ICH 

guidance for industry, ‘‘Q5A Viral 

Safety Evaluation of Biotechnology 

Products Derived from Cell Lines of 

Human or Animal Origin,’’ issued in 

September 1998. These revisions 

include descriptions of new classes of 

products now in scope, inclusion of 

new virus detection technologies, 

clarification of new validation 

strategies, and considerations specific to 

new manufacturing approaches, such as 

continuous manufacturing. The final 

guidance expands on the draft by 

including additional detail on the 

strategy for replacement of conventional 

testing methods with alternatives and 

additional details to better describe the 

scope of products addressed in the 

guidance. Additional definitions were 

added to the glossary to better align 

with terminology elsewhere in the 

guidance as well as guidances that may 

be read in parallel (e.g., ICH guidance 

for industry ‘‘Q13 Continuous 

Manufacturing of Drug Substances and 

Drug Products,’’ available at https://

www.fda.gov/media/165775/download). 

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 ‘‘Q5A(R2) Viral 

Safety Evaluation of Biotechnology 

Products Derived from Cell Lines of 

Human or Animal Origin.’’ 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 in 21 CFR parts 210 and 

211 pertaining to current good 

manufacturing practice have been 

approved under OMB control number 

0910–0139. The collections of 

information in 21 CFR part 312 for the 

submissions of investigational new drug 

applications have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

part 601 for the submissions of biologics 

license applications have been approved 

under OMB control number 0910–0338. 

The collections of information 21 CFR 

part 58 pertaining to good laboratory 

practices for nonclinical laboratory 

studies have been approved under OMB 

control number 0910–0119. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.regulations.gov, https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00407 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 Heart, Lung, 

and Blood Advisory Council. 

The meeting will be held virtually 

and is open to the public as indicated 

below. Individuals who plan to attend 

the virtual meeting 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 meeting can be 

accessed from the NIH Videocast at the 

following links: http://videocast.

nih.gov/ or https://www.nhlbi.nih.gov/ 

about/advisory-and-peer-reviewcommittees/advisory-council. 

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 Heart, Lung, 

and Blood Advisory Council. 

Date: February 6, 2024. 

Closed: 10:00 a.m. to 11:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge I, 6705 Rockledge Drive, 

Rockville, MD 20892 (Virtual Meeting). 

Open: 11:00 a.m. to 2:00 p.m. 

Agenda: To discuss program policies and 

issues. 

Place: National Institutes of Health, 

Rockledge I, 6705 Rockledge Dr., Bethesda, 

MD 20892 (Virtual Meeting). 

Virtual Access: https://www.nhlbi.nih.gov/ 

about/advisory-and-peer-review-committees/ 

advisory-council. 

Please note, the link to the videocast 

meeting will be posted within a week of the 

meeting date. 

Contact Person: Valerie L. Prenger, Ph.D., 

MPH, Deputy Director, Division of 

Extramural Research Activities, National 

Heart, Lung, and Blood Institute, National 

Institutes of Health, 6705 Rockledge Drive, 

Room 207–C, Bethesda, MD 20892–7924, 

301–435–0270, Valerie.Prenger@nih.gov. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

In the interest of security, NIH has 

procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors attending a meeting on 

campus or at an off-campus federal facility 

will be asked to show one form of 

identification (for example, a governmentissued photo ID, driver’s license, or passport) 

and to state the purpose of their visit. 


ddrumheller on DSK120RN23PROD with NOTICES1
1928 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 

Information is also available on the 

Institute’s/Center’s home page: 

www.nhlbi.nih.gov/meetings/nhlbac/ 

index.htm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 8, 2024. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–00440 Filed 1–10–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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: Eunice Kennedy 

Shriver, National Institute of Child Health 

and Human Development, Initial Review 

Group, Population Sciences Study Section. 

Date: March 1, 2024. 

Time: 10:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Eunice 

Kennedy Shriver, National Institute of Child 

Health and Human Development, 6710B 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Christiane M. Robbins, 

Scientific Review Officer, Scientific Review 

Branch (SRB), DER, Eunice Kennedy Shriver, 

National Institute of Child Health and 

Human Development, NIH, DHHS, 6710B 

Rockledge Drive, Rm. 2121B, Bethesda, MD 

20817, 301–451–4989, crobbins@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: January 5, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–00369 Filed 1–10–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; Member Conflict: Biobehavioral and 

Behavioral Sciences Study Section. 

Date: March 12, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, 6710B 

Rockledge Drive, Bethesda, MD 20817, 

(Virtual Meeting). 

Contact Person: Magnus A. Azuine, Ph.D., 

Scientific Review Branch Eunice Kennedy 

Shriver National Institute, of Child Health & 

Human Development, NIH 6710B Rockledge 

Drive, Room 2125C Bethesda, MD 20817, 

(301) 480–4645, magnus.azuine@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: January 8, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–00442 Filed 1–10–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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: Neurological Sciences 

Training Initial Review Group; Neurological 

Sciences Training 3 Study Section. 

Date: February 5–6, 2024. 

Time: 7:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: New Orleans Marriott, 555 Canal 

Street, New Orleans, LA 70130. 

Contact Person: Lataisia Cherie Jones, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Activities, NINDS/NIH, 6001 Executive 

Blvd., Rockville, MD 20852, 301–496–9223, 

lataisia.jones@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS.) 

Dated: January 5, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–00370 Filed 1–10–24; 8:45 am] 

BILLING CODE 4140–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1