Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Notices 4751 

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copies of the draft guidance to the Office 

of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Victoria Wagman, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled 

‘‘Recommendations To Reduce the Risk 

of Transfusion-Transmitted Malaria.’’ 

This guidance document provides blood 

establishments that collect blood and 

blood components with FDA’s revised 

recommendations to reduce the risk of 

TTM. Specifically, the guidance 

recommends selectively testing blood 

donations from donors at risk for 

malaria using an FDA-licensed donor 

screening NAT for Plasmodium species 

(spp.), the causative agents of malaria. 

The recommendations contained in 

this draft guidance apply to the 

collection of Whole Blood and blood 

components, except Source Plasma. We 

do not require blood establishments to 

screen Source Plasma donors for malaria 

risk factors because Source Plasma 

undergoes further manufacturing steps 

to effectively remove or inactivate 

pathogens such as Plasmodia spp. (see 

21 CFR 630.15(b)(8)). Licensed plasma 

derivatives manufactured from Source 

Plasma have not transmitted malaria. 

The draft guidance, when finalized, is 

intended to supersede the document 

entitled ‘‘Recommendations To Reduce 

the Risk of Transfusion-Transmitted 

Malaria,’’ dated December 2022. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Recommendations To Reduce the 

Risk of Transfusion-Transmitted 

Malaria.’’ 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 part 601 and 

Form FDA 356h have been approved 

under OMB control number 0910–0338; 

and the collections of information in 21 

CFR parts 606 and 630 have been 

approved under OMB control number 

0910–0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: January 10, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01028 Filed 1–15–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; 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 Center for 

Advancing Translational Sciences Special 

Emphasis Panel; NCATS RDCRC Grant 

Application Review. 

Date: February 3–5, 2025. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Address: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, 

Rockville, MD 20892. 

Meeting Format: In Person and Virtual 

Meeting. 

Contact Person: M. Lourdes Ponce, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, Suite 

1E504, Bethesda, MD 20892, (301) 435–0810, 

lourdes.ponce@nih.gov. 

Name of Committee: National Center for 

Advancing Translational Sciences Special 


ddrumheller on DSK120RN23PROD with NOTICES1
4752 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Notices 

Emphasis Panel; RDCRN Research Consortia 

B. 

Date: February 5–7, 2025. 

Time: 10:00 a.m. to 6:30 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Address: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, 

Rockville, MD 20892. 

Meeting Format: In Person and Virtual 

Meeting. 

Contact Person: Victor Henriquez, Ph.D., 

Scientific Review Officer, Office of Scientific 

Director, National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, Suite 

1E504, Bethesda, MD 20892, (301) 451–2405, 

henriquv@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: January 10, 2025. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2025–00980 Filed 1–15–25; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

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 of 

Mental Health Special Emphasis Panel; 

Suicide Prevention in Crisis Response and 

LMIC Across the Lifespan. 

Date: February 14, 2025. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: Virtual Meeting. 

Contact Person: Serena Chu, Ph.D., 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

Neuroscience Center, 6001 Executive Blvd., 

Bethesda, MD 20852, 301–500–5829, email: 

serena.chu@nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; 

Precision Mental Health: Develop Tools to 

Inform Treatment Selection in Depression. 

Date: February 18, 2025. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: Virtual Meeting. 

Contact Person: Regina Dolan-Sewell, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

Neuroscience Center, 6001 Executive Blvd., 

Bethesda, MD 20852, (240) 796–6785, email: 

regina.dolan-sewell@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.242, Mental Health Research 

Grants, National Institutes of Health, HHS) 

Dated: January 10, 2025. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2025–00857 Filed 1–15–25; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 

contract proposals 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 

and contract proposals, the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; PLCO U01 

SEP Review Meeting. 

Date: February 12, 2025. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W102, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Shakeel Ahmad, Ph.D., 

Branch Chief, Research Technology and 

Contract Review, Branch Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W102, Rockville, Maryland 20850, 

240–276–6442, ahmads@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; TEP–7: 

SBIR Contract Review Meeting (Review of 

SBIR Topics 431 and 439). 

Date: February 20, 2025. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Address: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W254, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Susan Lynn Spence, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W254, Rockville, Maryland 

20850, 240–620–0819, susan.spence@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–9: NCI 

Clinical and Translational Cancer Research. 

Date: February 27, 2025. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W542, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Biman Chandra Paria, 

Ph.D., Scientific Review Officer, Program 

Coordination and Referral Branch, Division 

of Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W542, Rockville, Maryland 20850, 

240–858–3814, pariab@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Research Specialist Award (R50) Clinician 

Scientist. 

Date: March 11–12, 2025. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W526, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Viktoriya Sidorenko, 

Ph.D., Scientific Review Officer, Program and 

Review Extramural Staff Training Office, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W526, Rockville, Maryland 

20850, 240–276–5073, viktoriya.sidorenko@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI SEP: 

The Confluence of Cancer Stigma and HIV 

Stigma in HIV-positive Individuals (R01 and 

R21). 

Date: March 20, 2025. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


ddrumheller on DSK120RN23PROD with NOTICES1