96264 Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 

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– 

1993–D–0285 for ‘‘Evaluating Target 

Animal Safety and Effectiveness of 

Antibacterial New Animal Drugs for 

Bovine Mastitis.’’ 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 

‘‘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 the Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Paulette Salmon, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–6556, 

pauline.salmon@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft revised GFI #49 entitled 

‘‘Evaluating Target Animal Safety and 

Effectiveness of Antibacterial New 

Animal Drugs for Bovine Mastitis.’’ This 

draft guidance replaces final GFI #49, 

issued in April 1996 entitled ‘‘Target 

Animal Safety And Drug Effectiveness 

Studies for Anti-Microbial Bovine 

Mastitis Products (Lactating and NonLactating Cow Products).’’ This draft 

guidance provides recommendations 

and considerations for bovine mastitis 

drug products with antibacterial activity 

that are administered by intramammary 

infusion. However, this guidance may 

also be applicable to mastitis products 

administered by other routes or to 

products using other technologies 

(including those with non-antibacterial 

mechanisms of action). 

This level 1 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 ‘‘Evaluating Target 

Animal Safety and Effectiveness of 

Antibacterial New Animal Drugs for 

Bovine Mastitis.’’ 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 514 have been 

approved under OMB control number 

0910–0032; 21 CFR 511.1 have been 

approved under OMB control number 

0910–0117. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

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

www.regulations.gov. 

Dated: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28362 Filed 12–3–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 96265 

1Although the regulation states that the Secretary 

of the Treasury must approve the issuance of a 

Finding, the Secretary of the Treasury delegated 

this authority to the Secretary of Homeland Security 

in Treasury Order No. 100–16, 68 FR 28322 (May 

23, 2003). Under Delegation Order 7010.3, Section 

II.A.3, the Secretary of Homeland Security 

delegated the authority to issue a Finding to the 

Commissioner of CBP, with the approval of the 

Secretary of Homeland Security. The Commissioner 

of CBP, in turn, delegated the authority to make a 

Finding regarding prohibited goods under 19 U.S.C. 

1307 to the Executive Assistant Commissioner, 

Office of Trade. 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Neurodevelopment, Oxidative 

Stress, and Synaptic Plasticity Fellowship 

Study Section. 

Date: December 20, 2024. 

Time: 10:00 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: Virtual Meeting. 

Contact Person: Robert C. Elliott, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5190, 

MSC 7846, Bethesda, MD 20892, 301–435– 

3009, elliotro@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: November 29, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–28391 Filed 12–3–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[CBP Dec. 24–17] 

Notice of Finding That Aluminum 

Extrusions and Profile Products and 

Derivatives Produced or Manufactured 

Wholly or in Part by Kingtom Aluminio 

S.R.L. With the Use of Convict, Forced 

or Indentured Labor Are Being, or Are 

Likely To Be, Imported Into the United 

States 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: General notice of forced labor 

finding. 

SUMMARY: This document notifies the 

public that U.S. Customs and Border 

Protection (CBP), with the approval of 

the Secretary of Homeland Security, has 

determined that aluminum extrusions 

and profile products and derivatives 

produced or manufactured wholly or in 

part by Kingtom Aluminio S.R.L. with 

the use of convict, forced or indentured 

labor, are being, or are likely to be, 

imported into the United States. 

DATES: This Finding applies to any 

merchandise described in Section II of 

this Notice that is imported on or after 

December 4, 2024. It also applies to any 

merchandise described in Section II of 

this Notice that has already been 

imported and has not been released 

from CBP custody before December 4, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Brian M. Hoxie, Director, Forced Labor 

Division, Trade Remedy Law 

Enforcement Directorate, Office of 

Trade, (202) 841–3081 or forcedlabor@

cbp.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Pursuant to section 307 of the Tariff 

Act of 1930, as amended (19 U.S.C. 

1307), ‘‘[a]ll goods, wares, articles, and 

merchandise mined, produced or 

manufactured wholly or in part in any 

foreign country by convict labor or/and 

forced labor or/and indentured labor 

under penal sanctions shall not be 

entitled to entry at any of the ports of 

the United States, and the importation 

thereof is hereby prohibited.’’ Under 

this section, ‘‘forced labor’’ includes ‘‘all 

work or service which is exacted from 

any person under the menace of any 

penalty for its nonperformance and for 

which the worker does not offer himself 

voluntarily’’ and includes forced or 

indentured child labor. 

U.S. Customs and Border Protection 

(CBP) regulations promulgated under 

the authority of 19 U.S.C. 1307 are 

found at sections 12.42 through 12.45 of 

title 19 of the Code of Federal 

Regulations (CFR) (19 CFR 12.42–12.45). 

Among other things, these regulations 

allow any person outside of CBP to 

communicate a belief that a certain 

‘‘class of merchandise . . . is being, or 

is likely to be, imported into the United 

States [in violation of 19 U.S.C. 1307].’’ 

19 CFR 12.42(a), (b). Upon receiving 

such information, the Commissioner of 

CBP will initiate an investigation if 

warranted by the circumstances. 19 CFR 

12.42(d). CBP also has the authority to 

self-initiate an investigation. 19 CFR 

12.42(a). 

If the Commissioner of CBP finds that 

the information available ‘‘reasonably 

but not conclusively’’ demonstrates that 

such merchandise within the purview of 

19 U.S.C. 1307 is being, or is likely to 

be, imported into the United States, the 

Commissioner of CBP will order port 

directors to seize and withhold the 

merchandise pending further 

instructions. 19 CFR 12.42(e). After 

issuance of such a withhold release 

order, the covered merchandise will be 

detained by CBP for an admissibility 

determination and will be excluded 

unless the importer demonstrates that 

the merchandise was not made using 

labor in violation of 19 U.S.C. 1307. 19 

CFR 12.43–12.44. The importer may 

also export the merchandise. 19 CFR 

12.44(a). 

These regulations also set forth the 

procedure for the Commissioner of CBP 

to issue a Finding when he determines 

that the merchandise is subject to the 

provisions of 19 U.S.C. 1307. Pursuant 

to 19 CFR 12.42(f), if the Commissioner 

of CBP finds that merchandise within 

the purview of 19 U.S.C. 1307 is being, 

or is likely to be, imported into the 

United States, the Commissioner will, 

with the approval of the Secretary of 

Homeland Security, publish a Finding 

to that effect in the Customs Bulletin 

and in the Federal Register.1 Under the 

authority of 19 CFR 12.44(b), CBP may 

seize and forfeit imported merchandise 

covered by a Finding. 

Through its investigation, CBP has 

determined that there is sufficient 

information to support a Finding that 

Kingtom Aluminio S.R.L. is using 

convict, forced, or indentured labor in a 

factory in the Dominican Republic to 

produce or manufacture in whole or in 

part aluminum extrusions and profile 

products and derivatives, and that such 

products are being, or are likely to be, 

imported into the United States. 

II. Finding 

A. General 

Pursuant to 19 U.S.C. 1307 and 19 

CFR 12.42(f), it is hereby determined 

that certain articles described in section 

II.B. of this Notice, that are produced or 

manufactured in whole or in part with 

the use of convict, forced, or indentured 

labor by Kingtom Aluminio S.R.L., are 

being, or are likely to be, imported into 

the United States. Based upon this 

determination, the port director may 

seize the covered merchandise for 

violation of 19 U.S.C. 1307 and 

commence forfeiture proceedings 

pursuant to 19 CFR part 162, subpart E, 

unless the importer establishes by 

satisfactory evidence that the 

merchandise was not produced or 

manufactured in any part with the use 

of prohibited labor specified in this 

Finding. 19 CFR 12.42(g). 


ddrumheller on DSK120RN23PROD with NOTICES1