Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices 85219 

January 19, 2023, July 22, 2024). 

*6. FDA, ‘‘Intenze Ink’’: Recall, posted July 

31, 2018; available at https://

www.accessdata.fda.gov/scripts/ires/ 

index.cfm?Product=165649 (accessed 

January 19, 2023, July 22, 2024). 

*7. FDA, ‘‘Eternal Ink’’: Recall, posted 

October 24, 2018; available at https://

www.accessdata.fda.gov/scripts/ires/ 

index.cfm?Product=167698 (accessed 

January 19, 2023, July 22, 2024). 

*8. FDA, ‘‘FDA Advises Consumers, Tattoo 

Artists, and Retailers to Avoid Using or 

Selling Certain Tattoo Inks Contaminated 

with Microorganisms’’; available at 

https://www.fda.gov/cosmetics/ 

cosmetics-recalls-alerts/fda-advisesconsumers-tattoo-artists-and-retailersavoid-using-or-selling-certain-tattoo-inks 

(accessed January 19, 2023, July 22, 

2024). 

*9. Nho, SW, S–J. Kim, O. Kweon, et al. 

‘‘Microbiological Survey of Commercial 

Tattoo and Permanent Makeup Inks 

Available in the United States.’’ Journal 

of Applied Microbiology, 124: 1294–1302 

(2018). 

Dated: October 21, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–24841 Filed 10–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4777] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments—Bulk Drug 

Substances Nominated for Inclusion 

on the Section 503A Bulk Drug 

Substances List 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pharmacy Compounding 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

December 4, 2024, from 8 a.m. to 3 p.m. 

Eastern Time. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. The public will also have 

the option to participate, and the 

advisory committee meeting will be 

heard, viewed, captioned, and recorded 

through an online teleconferencing and/ 

or video conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4777. 

The docket will close on December 3, 

2024. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

on December 3, 2024. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Comments received on or before 

November 19, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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– 

2024–N–4777 for ‘‘Pharmacy 

Compounding Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments— 

Bulk Drug Substances Nominated for 

Inclusion on the Section 503A Bulk 

Drug Substances List.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

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 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 the 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 


ddrumheller on DSK120RN23PROD with NOTICES1
85220 Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices 

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. 

FOR FURTHER INFORMATION CONTACT: 

Takyiah Stevenson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 240– 

402–2507, email: PCAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Background: Section 503A of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 353a) describes 

the conditions that must be satisfied for 

human drug products compounded by a 

licensed pharmacist in a State-licensed 

pharmacy or a Federal facility, or a 

licensed physician, to be exempt from 

the following three sections of the FD&C 

Act: (1) section 501(a)(2)(B) (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice requirements); 

(2) section 502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use); and (3) 

section 505 (21 U.S.C. 355) (concerning 

the approval of human drug products 

under new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). 

One of the conditions that must be 

satisfied for a drug product to qualify for 

the exemptions under section 503A of 

the FD&C Act is that the licensed 

pharmacist or licensed physician 

compounds the drug product using bulk 

drug substances (as defined in 21 CFR 

207.3) that: (1) comply with the 

standards of an applicable United States 

Pharmacopoeia (USP) or National 

Formulary monograph, if a monograph 

exists, and the USP chapter on 

pharmacy compounding; (2) if an 

applicable monograph does not exist, 

are drug substances that are components 

of drugs approved by the Secretary of 

Health and Human Services (the 

Secretary); or (3) if such a monograph 

does not exist and the drug substance is 

not a component of a drug approved by 

the Secretary, that appear on a list 

developed by the Secretary through 

regulations issued by the Secretary 

under section 503A(c) of the FD&C Act 

(the 503A Bulks List) (see section 

503A(b)(1)(A)(i) of the FD&C Act). 

Agenda: FDA, invited attendees, and 

the public will be able to attend the 

meeting in-person at FDA’s White Oak 

Campus (see ADDRESSES). The meeting 

presentations will also be heard, 

viewed, captioned, and recorded 

through an online teleconferencing and/ 

or video conferencing platform. 

The Committee will discuss the 

following bulk drug substances being 

considered for inclusion on the 503A 

Bulks List: AOD–9604-related bulk drug 

substances (AOD–9604 acetate, and 

AOD–9604 (free base)), CJC–1295- 

related bulk drug substances (CJC–1295 

(free base), CJC–1295 acetate, CJC–1295 

with drug affinity complex (DAC) (free 

base), CJC–1295 DAC acetate, and CJC– 

1295 DAC trifluoroacetate)), and 

Thymosin alpha-1-related bulk drug 

substances (Thymosin alpha-1 acetate, 

and Thymosin alpha-1 (free base)). The 

chart below identifies the use(s) FDA 

reviewed for each of the bulk drug 

substances being discussed at this 

advisory committee meeting. For 

nominated bulk drug substances, the 

nominators of these substances will be 

invited to make a short presentation 

supporting the nomination. 

Bulk drug substance Uses evaluated 

AOD–9604 (free base) ....................................................... *Obesity. 

AOD–9604 Acetate ............................................................

CJC–1295 (free base) ........................................................ Growth hormone deficiency. 

CJC–1295 Acetate .............................................................

CJC–1295 DAC (free base) ...............................................

CJC–1295 DAC Acetate ....................................................

CJC–1295 DAC Trifluoroacetate .......................................

Thymosin alpha-1(free base) ............................................. Hepatitis B. 

Thymosin alpha-1 Acetate ................................................. Hepatitis C. 

Human immunodeficiency virus (HIV). 

Coronavirus disease 2019 (COVID–19). 

Depressed response to vaccinations; adjuvant to flu vaccines. 

Malignant melanoma. 

Hepatocellular carcinoma (HCC). 

Non-small cell lung cancer (NSCLC). 

Sepsis. 

Infections after hematopoietic stem cell transplantation (HSCT). 

Chronic obstructive pulmonary disease (COPD). 

Myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices 85221 

presentations with audio and video 

components to allow the presentation of 

materials for online participants in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before November 19, 

2024, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled following FDA 

presentations. FDA has allotted 

approximately 1 hour for open public 

hearing presentations, which will be 

split to allow for public remarks on each 

substance. The sessions will begin at 

approximately 9:35 a.m., 10:50 a.m., and 

1:40 p.m. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, 

whether they would like to present 

online or in-person, and an indication of 

the approximate amount of time 

requested to make their presentation on 

or before November 8, 2024. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. FDA may also 

extend the time scheduled for open 

public hearing presentations depending 

on interest. Similarly, room for 

interested persons to participate inperson may be limited. If the number of 

registrants requesting to speak in-person 

during the open public hearing is 

greater than can be reasonably 

accommodated in the venue for the inperson portion of the advisory 

committee meeting, FDA may conduct a 

lottery to determine the speakers who 

will be invited to participate in-person. 

The contact person will notify 

interested persons regarding their 

request to speak and the timeframe for 

the presentation by November 12, 2024. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Takyiah 

Stevenson (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform in conjunction with 

the physical meeting room (see 

location). This waiver is in the interest 

of allowing greater transparency and 

opportunities for public participation, 

in addition to convenience for advisory 

committee members, speakers, and 

guest speakers. The conditions for 

issuance of a waiver under 21 CFR 10.19 

are met. 

Dated: October 21, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24828 Filed 10–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Final Effect of Designation of a Class 

of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice concerning 

the final effect of the HHS decision to 

designate a class of employees from the 

Metals and Controls Corp. in Attleboro, 

Massachusetts, as an addition to the 

Special Exposure Cohort (SEC) under 

the Energy Employees Occupational 

Illness Compensation Program Act of 

2000. 

FOR FURTHER INFORMATION CONTACT: 

Grady Calhoun, Director, Division of 

Compensation Analysis and Support, 

NIOSH, 1090 Tusculum Avenue, MS C– 

46, Cincinnati, OH 45226–1938, 

Telephone 513–533–6800. Information 

requests can also be submitted by email 

to DCAS@CDC.GOV. 

SUPPLEMENTARY INFORMATION: On 

September 9, 2024, as provided for 

under 42 U.S.C. 7384l(14)(C), the 

Secretary of HHS designated the 

following class of employees as an 

addition to the SEC: 

All atomic weapons employees who 

worked at Metals and Controls Corp. in 

Attleboro, Massachusetts, from January 1, 

1968, through September 21, 1995, for a 

number of work days aggregating at least 250 

work days, occurring either solely under this 

employment or in combination with work 

days within the parameters established for 

one or more other classes of employees 

included in the SEC. 

This designation became effective on 

October 9, 2024. Therefore, beginning on 

October 9, 2024, members of this class of 

employees, defined as reported in this notice, 

became members of the SEC. 

Authority: 2 U.S.C. 384q(b). 42 U.S.C. 

7384l(14)(C). 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2024–24833 Filed 10–24–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Small 

Business Innovation Research/Small 

Business Technology Transfer: Clinical Care 

and Health Interventions. 

Date: November 14–15, 2024. 

Time: 9:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: In Person and Virtual 

Meeting. 


ddrumheller on DSK120RN23PROD with NOTICES1