Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Notices 100509 

‘‘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 guidance to Office of the 

Chief Scientist, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO1, Silver Spring, MD 20993– 

0002. Send two self-addressed adhesive 

labels to assist that office in processing 

your request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Ross, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4332, Silver Spring, 

MD 20993–0002, 301–796–4880 (this is 

not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Registration and Listing of Cosmetic 

Product Facilities and Products.’’ 

On December 29, 2022, the President 

signed the Consolidated Appropriations 

Act, 2023 (Pub. L. 117–328) into law, 

which included MoCRA. Among other 

provisions, MoCRA added section 607 

to the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), establishing 

requirements for cosmetic product 

facility registration and cosmetic 

product listing. Section 607(a) of the 

FD&C Act (21 U.S.C. 364c(a)) requires 

every person that owns or operates a 

facility that engages in the 

manufacturing or processing of a 

cosmetic product for distribution in the 

United States to register each facility. In 

addition to the registration 

requirements, section 607(c) of the 

FD&C Act requires that for each 

cosmetic product, the responsible 

person submit to FDA ‘‘a cosmetic 

product listing.’’ Certain small 

businesses, as defined in section 612 of 

the FD&C Act (21 U.S.C. 364h), are 

exempt from the registration and listing 

requirements. 

In the Federal Register of December 

19, 2023 (88 FR 87780), we made 

available a final guidance for industry 

entitled ‘‘Registration and Listing of 

Cosmetic Product Facilities and 

Products.’’ This guidance also included 

a new draft section, Appendix B, for 

comment purposes only, that describes 

frequently asked questions and answers 

about cosmetic product facility 

registrations and product listing 

submissions and gave interested parties 

an opportunity to submit comments by 

January 18, 2024, for us to consider 

before beginning work on the final 

version of Appendix B. We received a 

few comments on the draft guidance 

Appendix B frequently asked questions 

and answers and have modified the 

final guidance Appendix B in response 

to these comments and for clarity, 

where appropriate. In addition, we 

made editorial changes to the final 

guidance to improve clarity. Finally, 

three new frequently asked questions 

and answers in Appendix B of this 

guidance are highlighted in grey and are 

marked ‘‘for comment purposes only’’ to 

provide an opportunity for comment 

before they are finalized. Aside from the 

three new frequently asked questions 

and answers in Appendix B, this 

guidance finalizes the draft guidance 

Appendix B that was published on 

December 19, 2023 (88 FR 87780) and 

reissues the final guidance with minor 

changes for clarity. No changes were 

made to Appendix A of the final 

guidance. 

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 ‘‘Registration and 

Listing of Cosmetic Product Facilities 

and Products.’’ 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 section 607 of the FD&C 

Act have been approved under 0910– 

0599. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/CosmeticGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: December 5, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29237 Filed 12–11–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5375] 

Revocation of Authorization of 

Emergency Use of B. Braun Medical’s 

Perfusor Space Syringe Infusion Pump 

System, Infusomat Space Volumetric 

Infusion Pump System, and Outlook 

ES; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to B. Braun Medical, Inc., for the 

Perfusor Space Syringe Infusion Pump 

System, Infusomat Space Volumetric 

Infusion Pump System, and Outlook ES. 

FDA revoked this Authorization under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) as requested by the 

Authorization holder. The revocation, 

which includes an explanation of the 

reasons for revocation, is reprinted at 

the end of this document. 


ddrumheller on DSK120RN23PROD with NOTICES1
100510 Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Notices 

DATES: The revocation of the 

Authorization for the B. Braun Medical, 

Inc.’s Perfusor Space Syringe Infusion 

Pump System, Infusomat Space 

Volumetric Infusion Pump System, and 

Outlook ES is effective as of October 1, 

2024. 

ADDRESSES: Submit written requests for 

a single copy of the revocation to the 

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 request or 

include a Fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Gertz, Office of Product 

Evaluation and Quality, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3216, 

Silver Spring, MD 20993–0002, 240– 

402–9677 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

radiological, or nuclear agent or agents. 

Among other things, section 564 of the 

FD&C Act allows FDA to authorize the 

use of an unapproved medical product 

or an unapproved use of an approved 

medical product in certain situations. 

On April 11, 2020, FDA issued the 

Authorization to B. Braun Medical, Inc., 

for the Perfusor Space Syringe Infusion 

Pump System, Infusomat Space 

Volumetric Infusion Pump System, and 

Outlook ES, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 14, 2020 (85 FR 

42407), as required by section 564(h)(1) 

of the FD&C Act. 

Subsequent updates to the 

Authorization were made available on 

FDA’s website. The authorization of a 

device for emergency use under section 

564 of the FD&C Act may, pursuant to 

section 564(g)(2) of the FD&C Act, be 

revoked when the criteria under section 

564(c) of the FD&C Act for issuance of 

such authorization are no longer met 

(section 564(g)(2)(B) of the FD&C Act), 

or other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. Authorization Revocation Request 

In a request received by FDA on 

August 6, 2024, B. Braun Medical, Inc., 

requested the withdrawal of, and on 

October 1, 2024, FDA revoked, the 

Authorization for the B. Braun Medical 

Inc.’s Perfusor Space Syringe Infusion 

Pump System, Infusomat Space 

Volumetric Infusion Pump System, and 

Outlook ES. Because B. Braun Medical 

Inc., notified FDA about the lack of 

customer interest and lack of need for 

use of the device for the indications 

granted under this EUA considering the 

improved COVID–19 situation and 

requested FDA withdraw the B. Braun 

Medical Inc.’s Perfusor Space Syringe 

Infusion Pump System, Infusomat Space 

Volumetric Infusion Pump System, and 

Outlook ES, FDA has determined that it 

is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocation is available on the internet at 

https://www.regulations.gov/. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA of the 

B. Braun Medical Inc.’s Perfusor Space 

Syringe Infusion Pump System, 

Infusomat Space Volumetric Infusion 

Pump System, and Outlook ES. The 

revocation in its entirety follows and 

provides an explanation of the reasons 

for revocation, as required by section 

564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Notices 100511 


ddrumheller on DSK120RN23PROD with NOTICES1EN12DE24.015</GPH>

U.S. FOOD & DRUG APMiNISTRATlON 

October 1, 2024 

V enkata Vempati 

B. Braun Medical, Irie. 

3773 Corporate Pkwy 

Center Valley, PA 18034 

Re: Revocation ofEUA200227 

DearVenkata Vempati: 

This letter serves to correct an error in our October 1, 2024, revocation letter. We inadvertently 

stated that this EUA had been issued on April 1, 2020. We have corrected that date below to 

reflect the April 11, 2020, issuance. The signature on this letter will reflect the date of the 

correction but the October 1,2024 date of the letter reflects the effective date of the revocation. 

This letter is in response to your request dated August 6, 2024, that the Food and Drug 

Administration (FDA) provide advice about the process for withdrawing the Emergency Use 

Authorization (EUA200227) issued on April 11, 2020, for B. Braun Medical's Perfusor Space 

Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and 

Outlook ES. We are considering this as a request to revoke this EUA. Your request is in 

response to the lack of customer interest and lack of need for use of the device for the indications 

granted under this EUA considering the improved COVID-19 situation. The B. Braun Medical 's 

Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump 

System, and OUtlook ES were authorized for emergency use by FDA for use in the tracheal delivery 

of c-0ntinuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of 

having COVID-19 and for ground medical transport use of the Infusomat Space Volumetric Infusion 

Pump System. 

FDA tmderstands that B. Braun Medical does not plan to continue to distribute the Perfusor 

Space Syringe Infusion Pump System, lnfusomat Space Volumetric Infusion Pump System, and 

Outlook ES for the indications authorized in EUA200227. If you decide later that you want to do 

so, those indications would require emergency use authorization or marketing authorization 

(premarket approval under section 515 of the Federal Food Drug and Cosmetic Act (the Act), 

510(k) clearance (premarket notification under section 510(k) of the Act), or De Novo 

classification (under section 513 of the Act)). 

You indicatedin your email dated September 16, 2024, that the EUA included additional 

indications beyond the 51 0(k)-cleared device indications and that the only changes that you 

made to the 510(k)-cleared device were to include an addendum to the instructions for use and to 

add fact sheets to the existing labeling. In that email, you committed to, upon EUA revocation, 

do the following: 

1) Post a customer letter on your website and send the letter to customers to direct them to 

dispose of the EDA-related labeling; 

f>agel-Verikata Vempati, B. BraunMedical 
100512 Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Notices 

Dated: December 4, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29247 Filed 12–11–24; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Office of the General Counsel, 

Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: This document revises and 

restates the Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services, Office of the General 

Counsel (OGC). Issuance of this 

Statement of Organization rescinds all 

prior Statements of Organization. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Park, Principal Deputy General 

Counsel, Office of the General Counsel, 

Office of the Secretary, 200 


ddrumheller on DSK120RN23PROD with NOTICES1EN12DE24.016</GPH>

U.S. FOOD & DRUG APMINIS.TRAT!ON 

2) Remove from the website the current EUA Customer Letter, the Fact Sheets for 

Healthcare Providers, and the corresponding fustructions for Use addendum for the B. 

Braun Space and Outlook Pumps; and 

3) Notify customers, via the B. Braun website, that the EUA for the B. Braun infusion 

pumps has been revoked, and that customers should dispose of the Customer Letter, the 

Fact Sheets for Healthcare Providers, and the fustructions for Use addendum for the B. 

Braun Space and Outlook Pumps. 

In an additional email, dated September 25, 2024, you indicated that you also intend to: 

l) fustruct customers to dispose of the EDA-specific IFU addendum and to use the device 

with the 510(k) cleared labeling; and 

2) Offer customers the ability to either dmvnload the electronic copy of the 51 0(k)-cleared 

device labeling from B. Braun's website or contact the customer representative to request 

a paper copy of the same, as needed. 

The authorization of a device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) oftheAct). Because B. Braun Medical fuc. has requested that FDA 

revoke the EDA for the Perfusor Space Syringe Infusion Pump System, lnfusomat Space 

Volumetric fufusion Pump System, and Outlook ES, FDA has determined that it is appropriate to 

protect the public health or safety to revoke this authorization. Accordingly, FDA hereby 

revokes, pursuant to 564(g)(2)(C), EUA200227 for the B. Braun Perfusor Syringe Infusion Pump 

System, Outlook ES and the fufusomat Space Volumetric Infusion Pump. As of the date of this 

letter, the Perfusor Space Syringe fufusion Pump System, fufusomat Space Volumetric fufusion 

Pump System, and Outlook ES are no longer authorized for emergency use by FDA 1. 

Notice of this revocation ·will be published in the Federal Register, pursuantto section 564(h)(1) 

of the Act. • 

Sincerely, 

!Isl/ 

Ellen J. Flannery, J.D. 

Deputy Center Director for Policy 

Director, Office of Policy 

Center for Devices and Radiological Health 

Food and Drug Administration 

1 As outlined in our April I, 2020, EUA letter, the R Braun Space and Outlook Prnnps have each respectively 

received marketing authorization from FDA under section 510(1,) of the Act This EUA revocation does not inipact 

the 510(1()-cleared devices or their indications for use. 

Page 2 - Venkata Vempati, B. Braun Medical