Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Notices 100507 

(see National Archives and Records 

Administration-approved record 

retention and disposition schedules 

DAA–0292–2019–0009–0001 and DAA– 

0292–2019–0009–0002). 

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL

SAFEGUARDS: 

Information in this system is 

safeguarded in accordance with 

applicable laws, rules, and policies. 

Access to the records is restricted to 

authorized personnel who are advised 

of the confidentiality of the records and 

the civil and criminal penalties for 

misuse. All record keepers are required 

to maintain appropriate administrative, 

technical, and physical safeguards to 

protect the records from unauthorized 

access. Administrative safeguards 

include background checks, as well as 

training individuals who have access to 

the records on how to handle them 

appropriately, incident response plans, 

mandatory security and privacy 

awareness training, limiting access to 

individuals who need to know the 

information, and reviewing security 

controls on an ongoing basis. Technical 

safeguards include the use of antivirus 

software, vulnerability patching, multifactor authentication when required, or 

username and password, and storing 

electronic records in encrypted form, to 

limit system access to authorized users. 

Physical safeguards include storing hard 

copy records and computer terminals 

used to access electronic records in 

physically locked locations when not in 

use. Safeguards conform to the HHS 

Information Security Program, https://

www.hhs.gov/ocio/securityprivacy/ 

index.html. 

RECORD ACCESS PROCEDURES: 

Individuals may request access to a 

record about them in this system of 

records by submitting a written access 

request to the System Manager. The 

request must include, as applicable, the 

individual’s name, Alien Registration 

Number, date and place of birth, 

telephone number and/or email address, 

current address, and signature. In 

addition, to further verify the 

individual’s identity, the individual 

must provide either a notarization of the 

request or a written certification that the 

requester is the individual who the 

requester claims to be and understands 

that the knowing and willful request for, 

or acquisition of, a record pertaining to 

an individual under false pretenses is a 

criminal offense under the Privacy Act, 

subject to a fine of up to $5,000. An 

individual may also request an 

accounting of disclosures that have been 

made of any records about that 

individual. Verification of identity is 

also required for a parent or legal 

guardian who makes a request on behalf 

of a minor (in addition to verifying the 

minor’s identity). 

CONTESTING RECORD PROCEDURES: 

Individuals seeking to amend a record 

about them in this system of records 

must submit a written request for 

amendment to the System Manager. The 

request must provide the same 

information described under ‘‘Record 

Access Procedures,’’ including identity 

verification information, and must 

specify the information that is 

contested, the corrective action sought, 

and the reason(s) for requesting the 

correction, and include supporting 

information. The right to contest records 

is limited to information that is factually 

inaccurate, incomplete, irrelevant, or 

untimely (obsolete). 

NOTIFICATION PROCEDURES: 

Individuals seeking to determine 

whether this system of records contains 

information about them must submit a 

written notification request to the 

System Manager. The request must 

include the same information described 

under ‘‘Record Access Procedures,’’ 

including identity verification 

information. 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

None. 

HISTORY: 

81 FR 46682 (July 18, 2016), 83 FR 

6591 (Feb. 14, 2018). 

[FR Doc. 2024–29113 Filed 12–11–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0008] 

Advisory Committee; Science Board to 

the Food and Drug Administration; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the Science 

Board to the Food and Drug 

Administration by the Commissioner of 

Food and Drugs (the Commissioner). 

The Commissioner has determined that 

it is in the public interest to renew the 

Science Board to the Food and Drug 

Administration for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

June 26, 2026, expiration date. 

DATES: Authority for the Science Board 

to the Food and Drug Administration 

will expire on June 26, 2026, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Rakesh Raghuwanshi, Office of the 

Chief Scientist, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3309, Silver Spring, 

MD 20993–0002, 301–796–4769, 

rakesh.raghuwanshi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Science Board to the 

Food and Drug Administration (the 

Committee). The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee shall provide advice 

to the Commissioner and other 

appropriate officials on specific 

complex scientific and technical issues 

important to FDA and its mission, 

including emerging issues within the 

scientific community. Additionally, the 

Committee will provide advice that 

supports the Agency in keeping pace 

with technical and scientific 

developments, including in regulatory 

science; and input into the Agency’s 

research agenda and on upgrading its 

scientific and research facilities and 

training opportunities. It will also 

provide, where requested, expert review 

of Agency-sponsored intramural and 

extramural scientific research programs. 

The Committee shall consist of a core 

of 21 voting members including a Chair 

and Co-Chair. The members, Chair, and 

Co-Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of food science, safety, and nutrition; 

chemistry; pharmacology; translational 

and clinical medicine and research; 

toxicology; biostatistics; medical 

devices; imaging; robotics; cell and 

tissue based products; regenerative 

medicine; public health and 

epidemiology; international health and 

regulation; product safety; product 

manufacturing sciences and quality; and 

other scientific areas relevant to FDAregulated products such as systems 


ddrumheller on DSK120RN23PROD with NOTICES1
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