100508 Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Notices 

biology, informatics, nanotechnology, 

and combination products. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Non-Federal 

members of this committee will serve as 

Special Government Employees or 

representatives. Federal members will 

serve as Regular Government Employees 

or Ex-Officios. The core of voting 

members may include one technically 

qualified member, selected by the 

Commissioner or designee, who is 

identified with consumer interests and 

is recommended by either a consortium 

of consumer-oriented organizations or 

other interested persons. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members), or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, an additional non-voting 

representative member of consumer 

interests and an additional non-voting 

representative member of industry 

interests will be included in addition to 

the voting members. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

committees-and-meeting-materials/ 

science-board-food-and-drugadministration or by contacting the 

Designated Federal Officer (see FOR

FURTHER INFORMATION CONTACT). In light 

of the fact that no change has been made 

to the committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act as 

amended (5 U.S.C. 1001 et seq.). For 

general information related to FDA 

advisory committees, please visit us at 

https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: December 4, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29231 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–2023–D–1716] 

Registration and Listing of Cosmetic 

Product Facilities and Products; 

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 final 

guidance for industry entitled 

‘‘Registration and Listing of Cosmetic 

Product Facilities and Products.’’ The 

guidance will assist persons submitting 

cosmetic product facility registrations 

and product listing submissions to FDA 

under the Modernization of Cosmetics 

Regulation Act of 2022 (MoCRA). This 

guidance includes three new draft 

frequently asked questions and answers 

about cosmetic product facility 

registrations and product listing 

submissions, in Appendix B, for 

comment purposes only. Aside from the 

three new draft frequently asked 

questions and answers, this guidance 

finalizes the draft Appendix B 

published in an otherwise final 

guidance on December 19, 2023. This 

guidance also includes minor changes to 

the final guidance for clarity. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 12, 2024. 

However, the portion of this guidance in 

Appendix B that describes three new 

frequently asked questions and answers, 

is being distributed for comment 

purposes only. To ensure that the 

Agency considers your comment on this 

draft section before it begins work on 

the final version of this section of the 

guidance, submit either electronic or 

written comments on this section by 

January 13, 2025. 

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– 

2023–D–1716 for ‘‘Registration and 

Listing of Cosmetic Product Facilities 

and Products.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
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