4750 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Notices 

1Section 505(d) of the FD&C Act provides that 

FDA shall refuse to approve an application if, 

among other reasons, ‘‘upon the basis of the 

information submitted to him as part of the 

application, or upon the basis of any other 

information before him with respect to such drug, 

he has insufficient information to determine 

whether such drug is safe for use under such 

conditions’’ or ‘‘there is a lack of substantial 

evidence that the drug will have the effect it 

purports or is represented to have under the 

conditions of use prescribed, recommended, or 

suggested in the proposed labeling thereof[.]’’ 

Sections 505(d)(4) and 505(d)(5) of the FD&C Act. 

II. Notice of Opportunity for a Hearing 

For the reasons stated above and as 

explained in the September 18, 2024, 

complete response letter, notice is given 

to Vanda and all other interested 

persons that the Center Director 

proposes that FDA issue an order 

refusing to approve NDA 218489 under 

section 505(c) of the FD&C Act, on the 

grounds that the application fails to 

meet the criteria for approval under 

section 505(d) of the FD&C Act because 

there is a lack of substantial evidence 

that the drug is effective, and the drug 

has not been shown to be safe, for the 

proposed conditions of use, including 

for the proposed indication of ‘‘the 

treatment of [symptoms of] or [nausea 

in] in gastroparesis’’ (sections 505(d)(4) 

and 505(d)(5) of the FD&C Act).1

Vanda may request a hearing before 

the Commissioner of Food and Drugs 

(the Commissioner) on the Center 

Director’s proposal to refuse to approve 

NDA 218489. Pursuant to 

§ 314.200(c)(1) (21 CFR 314.200(c)(1)), if 

Vanda decides to seek a hearing, it must 

file: (1) a written notice of participation 

and request for a hearing on or before 

30 days after the notice is published in 

the Federal Register and (2) the studies, 

data, information, and analyses relied 

upon to justify a hearing, as specified in 

§ 314.200, on or before 60 days after the 

date the notice is published in the 

Federal Register. 

As stated in § 314.200(g), a request for 

a hearing may not rest upon mere 

allegations or denials but must present 

specific facts showing that there is a 

genuine and substantial issue of fact 

that requires a hearing to resolve. We 

note in this regard that because CDER 

proposes to refuse to approve NDA 

218489 based on the multiple 

deficiencies summarized above, any 

hearing request from Vanda should 

address all those deficiencies. Failure to 

request a hearing within the time 

provided and in the manner required by 

§ 314.200 constitutes a waiver of the 

opportunity to request a hearing. If a 

hearing request is not properly 

submitted, FDA will issue a notice 

refusing to approve NDA 218489. 

The Commissioner will grant a 

hearing if there exists a genuine and 

substantial issue of fact or if the 

Commissioner concludes that a hearing 

would otherwise be in the public 

interest. See § 314.200(g)(6). If a hearing 

is granted, it will be conducted 

according to the procedures provided in 

21 CFR parts 10 through 16. See 21 CFR 

314.201. 

Paper submissions under this notice 

of opportunity for a hearing should be 

filed in one copy, except for those 

submitted as ‘‘Confidential 

Submissions’’ (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’ in 

ADDRESSES). Except for data and 

information prohibited from public 

disclosure under 21 U.S.C. 331(j) or 18 

U.S.C. 1905, submissions may be seen 

in the Dockets Management Staff Office 

between 9 a.m. and 4 p.m., Monday 

through Friday, and on the internet at 

https://www.regulations.gov. This notice 

is issued under section 505(c)(1)(B) of 

the FD&C Act and §§ 314.110(b)(3) and 

314.200. 

Dated: January 13, 2025. 

Patrizia Cavazzoni, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2025–01027 Filed 1–15–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–D–0187] 

Recommendations To Reduce the Risk 

of Transfusion-Transmitted Malaria; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

document entitled ‘‘Recommendations 

To Reduce the Risk of TransfusionTransmitted Malaria.’’ The draft 

guidance document provides blood 

establishments that collect blood and 

blood components with FDA’s revised 

recommendations to reduce the risk of 

transfusion-transmitted malaria (TTM). 

The guidance recommends selectively 

testing blood donations from donors at 

risk for malaria using an FDA-licensed 

donor screening nucleic acid test (NAT) 

for Plasmodium species (spp.), the 

causative agents of 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. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 17, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2000–D–0187 for ‘‘Recommendations To 

Reduce the Risk of TransfusionTransmitted Malaria.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 


ddrumheller on DSK120RN23PROD with NOTICES1
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