Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 563 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

citation 

Room 2005, Building 6, No. 77 Heshun Road, 

Suzhou Industrial Park, Suzhou, Jiangsu, 

215000, China; and Room 301 Building 3, No. 

99 Jinyahu Avenue, Suzhou Industrial Park, 

Jiangsu Pilot Free Trade Zone, China. 

* * * * * * 

Wuhu Kewei Zhaofu Electronics Co., Ltd., 

West side of North Jiuhua Road, Economic and 

Technological Development Zone, Wuhu, 

Anhui, China; and No.10 Ruifu Road, 

Longshan Avenue, Wuhu Economic and Technological Development Zone, Wuhu, Anhui, 

241000, China. 

For all items subject to the EAR. 

(See § 744.11 of the EAR).

Presumption of denial.90 FR [INSERT FR PAGE NUMBER AND 1/6/25. 

* * * * * * 

Yaguang Technology Group Co., Ltd., a.k.a., the 

following one alias: 

—Sunbird Yachting Co., Ltd. 

For all items subject to the EAR. 

(See § 744.11 of the EAR).

Presumption of denial.90 FR [INSERT FR PAGE NUMBER AND 1/6/25. 

Yacht Industrial Park, Yuanjiang, China; and No. 

18, Shijihu Road, Yuanjiang City, Yiyang City, 

China; and Yaguang Science and Technology 

Park, No. 1820 Yuelu West Avenue, 

Changsha, China. 

******

*******

PAKISTAN ............ * * * * * * 

Emerging Future Solutions Private Limited, a.k.a., 

the following four aliases: 

—Emerging Future Solutions; 

—Emerging Future Solutions (Pvt) Ltd Pakistan; 

—Emerging Future Solutions Pvt Ltd.; and 

—Emerging Future Solutions Limited. 

For all items subject to the EAR. 

(See § 744.11 of the EAR).

Presumption of denial.90 FR [INSERT FR PAGE NUMBER AND 1/6/25. 

Office No. 46–A, Street No. 5, Chaklala SchemeIII, Rawalpindi, 46000, Pakistan. 

* * * * * * 

* * * * * * * 

* * * * * 

Matthew S. Borman, 

Principal Deputy Assistant Secretary for 

Strategic Trade and Technology Security. 

[FR Doc. 2024–31468 Filed 1–3–25; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 211 

[Docket No. FDA–2024–D–5374] 

Considerations for Complying With 21 

CFR 211.110; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Availability of draft guidance. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Considerations for Complying With 21 

CFR 211.110.’’ This guidance, when 

finalized, will describe considerations 

for complying with the requirements for 

ensuring batch uniformity and drug 

product integrity. In addition, this 

guidance discusses related quality 

considerations for drug products that 

are manufactured using advanced 

manufacturing. FDA is committed to 

supporting and enabling pharmaceutical 

innovation and modernization as part of 

the Agency’s mission to protect and 

promote the public health. FDA 

encourages industry representatives and 

manufactures who are interested in 

using innovative control strategies to 

contact the Agency. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 7, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


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564 Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 

1See 21 CFR parts 210 and 211. Positron 

emission tomography drug products are subject to 

CGMP regulations at 21 CFR part 212 and are not 

covered by this guidance. 2See § 211.110. 

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–D–5374 for ‘‘Considerations for 

Complying With 21 CFR 211.110.’’ 

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 this draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; or 

Policy and Regulations Staff, HFV–6, 

Center for Veterinary Medicine, Food 

and Drug Administration, 7500 Standish 

Place, Rockville, MD 20855. Send one 

self-addressed 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: 

Brittany Avaritt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6649, 

Silver Spring, MD 20993–0002, 240– 

402–5982; James Myers, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bld. 71, Rm. 

7301, Silver Spring, MD 20993–002, 

240–402–7911; or Kevin Rice, Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–402–0680. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Considerations for Complying with 21 

CFR 211.110.’’ This guidance, when 

finalized, will describe considerations 

for complying with the requirements in 

§ 211.110 (21 CFR 211.110) to ensure 

batch uniformity and drug product 

integrity. In addition, this guidance 

discusses related quality considerations 

for drug products that are manufactured 

using advanced manufacturing. It also 

discusses how manufacturers can 

incorporate process models into 

commercial manufacturing control 

strategies. This guidance applies to the 

manufacture of human drug products, 

including biological products, and 

animal drug products. This guidance 

does not apply to the manufacture of 

active ingredients. 

To ensure batch uniformity and drug 

product integrity, the current good 

manufacturing practice (CGMP) 

regulations 1 require, among other 

things, that manufacturing processes are 

designed and controlled to ensure that 

in-process materials consistently and 

reliably meet predetermined quality 

requirements.2 This guidance explains 

the requirements for drug product 

manufacturing in § 211.110. This 

guidance also describes considerations 

for the use of advanced manufacturing 

(e.g., 3D printing, continuous 

manufacturing) and the use of process 

models as a part of commercial 

manufacturing control strategies. FDA 

supports the adoption of advanced 

manufacturing as a foundation for 

improving the overall quality and 

availability of drug products for 

patients. 

All manufacturers, regardless of 

whether they are using advanced 

manufacturing, should apply a 

scientific- and risk-based approach to 

controlling processes and ensuring drug 

product quality. This approach should 

be based on robust product and process 

understanding. Advanced 

manufacturing (such as continuous 

manufacturing) generally lends itself to 

more extensive understanding and 

control of the manufacturing process; 

thus, it is generally suitable for 

implementing process models as part of 

the control strategy. FDA is aware of 

industry’s interest in using in-process 

control strategies that rely solely on 

process models to satisfy the 

requirements of § 211.110. However, 

control strategies that rely solely on 

current process models would be 

insufficient to satisfy the requirements 

of § 211.110. 

FDA is committed to supporting and 

enabling pharmaceutical innovation and 

modernization as part of the Agency’s 

mission to protect and promote the 

public health. This guidance provides 

information on how process models can 

be paired with in-process material 

testing or process monitoring to meet 

current regulatory requirements. As the 

science supporting innovative inprocess control tools and methods 

continues to develop, FDA anticipates 

that these scientific advancements can 

be leveraged to pursue in-process 

control strategies that increasingly rely 

on process models. FDA encourages 

industry representatives and 

manufacturers to discuss their proposed 

innovative control strategies with the 

Agency to help inform future policy 

development. 

This 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 ‘‘Considerations for Complying With 


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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 565 

3The Office of the Federal Register has published 

this document under the category ‘‘Rules and 

Regulations’’ pursuant to its interpretation of 1 CFR 

5.9(b). We note that the categorization as such for 

purposes of publication in the Federal Register 

does not affect the content or intent of the 

document. See 1 CFR 5.1(c). 

21 CFR 211.110.’’ 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.3

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 (44 U.S.C. 3501– 

3521). The collections of information in 

parts 210 and 211 relating to CGMP 

have been approved under OMB control 

number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics, https://

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

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

www.regulations.gov. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31356 Filed 1–3–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2024–1099] 

Security Zone; Potomac River and 

Anacostia River, and Adjacent Waters, 

Washington, DC 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a security zone along the Potomac River, 

Anacostia River, and adjacent waters at 

Washington, DC, for the State Funeral 

for former President James Carter. This 

action is necessary to protect 

government officials, mitigate potential 

terrorist acts and incidents, and enhance 

public and maritime safety and security 

immediately before, during, and after 

this activity. During the enforcement 

period, entry into or remaining within 

the zone is prohibited unless authorized 

by the Captain of the Port or their 

designated representative. 

DATES: The regulations in 33 CFR 

165.508 will be enforced from 8 a.m., 

January 7, 2025, through 4 p.m., January 

9, 2025, for the security zone location 

identified in 33 CFR 16.508(a)(6). 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call or 

email LCDR Kate Newkirk, U.S. Coast 

Guard Sector Maryland-National Capital 

Region, Waterways Management 

Division; telephone 410–576–2596, 

email Kate.M.Newkirk@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce regulations in 33 

CFR 165.508 for the locations identified 

in paragraph (a)(6) from 8 a.m., January 

7, 2025, through 4 p.m., January 9, 2025. 

This action is being taken to protect 

government officials, mitigate potential 

terrorist acts and incidents, and enhance 

public and maritime safety and security 

immediately before, during, and after 

this event. Our regulations for the 

Security Zone; Potomac River and 

Anacostia River, and adjacent waters at 

Washington, DC. The regulation at 33 

CFR 165.508(a)(6) specifies the location 

for this security zone as an area that 

includes all navigable waters described 

in paragraphs (a)(1) through (3), which 

includes Zones 1, 2, and 3. 

• Security Zone 1, paragraph (a)(1); 

all navigable waters of the Potomac 

River, from shoreline to shoreline, 

bounded to the north by the Francis 

Scott Key (US–29) Bridge, at mile 113, 

and bounded to the south by a line 

drawn from the Virginia shoreline at 

Ronald Reagan Washington National 

Airport at 38°51′21.3′′ N, 077°02′00.0′′ 

W, eastward across the Potomac River to 

the District of Columbia shoreline at 

Hains Point at position 38°51′24.3′′ N, 

077°01′19.8′′ W, including the waters of 

the Boundary Channel, Pentagon 

Lagoon, Georgetown Channel Tidal 

Basin, and Roaches Run. 

• Security Zone 2, paragraph (a)(2); 

all navigable waters of the Anacostia 

River, from shoreline to shoreline, 

bounded to the north by the John Philip 

Sousa (Pennsylvania Avenue) Bridge, at 

mile 2.9, and bounded to the south by 

a line drawn from the District of 

Columbia shoreline at Hains Point at 

position 38°51′24.3′′ N, 077°01′19.8′′ W, 

southward across the Anacostia River to 

the District of Columbia shoreline at 

Giesboro Point at position 38°50′52.4′′ 

N, 077°01′10.9′′ W, including the waters 

of the Washington Channel. 

• Security Zone 3 paragraph (a)(3); all 

navigable waters of the Potomac River, 

from shoreline to shoreline, bounded to 

the north by a line drawn from the 

Virginia shoreline at Ronald Reagan 

Washington National Airport, at 

38°51′21.3′′ N, 077°02′00.0′′ W, eastward 

across the Potomac River to the District 

of Columbia shoreline at Hains Point at 

position 38°51′24.3′′ N, 077°01′19.8′′ W, 

thence southward across the Anacostia 

River to the District of Columbia 

shoreline at Giesboro Point at position 

38°50′52.4′′ N, 077°01′10.9′′ W, and 

bounded to the south by the Woodrow 

Wilson Memorial (I–95/I–495) Bridge, at 

mile 103.8. 

During the enforcement period, as 

specified in § 165.508(b), entry into or 

remaining in these zones is prohibited 

unless authorized by the Coast Guard 

Captain of the Port Maryland-National 

Capital Region. Public vessels and 

vessels already at berth at the time of 

the security zone is implemented do not 

have to depart the security zone. All 

vessels underway within the security 

zone at the time the security zone is 

implemented are to depart the zone. To 

seek permission to transit the zone, the 

Captain of the Port Maryland-National 

Capital Region can be contacted at 

telephone number (410) 576–2525 or on 

Marine Band Radio, VHF–FM channel 

16 (156.8 MHz). Coast Guard vessels 

enforcing this zone can be contacted on 

Marine Band Radio, VHF–FM channel 

16 (156.8 MHz). The Coast Guard may 

be assisted by other Federal, state, or 

local law enforcement agencies in 

enforcing this regulation. If the Captain 

of the Port or his designated on-scene 

patrol personnel determines the security 

zone need not be enforced for the full 

duration stated in this notification, a 

Broadcast Notice to Mariners may be 

used to suspend enforcement and grant 

general permission to enter the security 

zone. 

In addition to this notification of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification to this enforcement period 

via the Local Notice to Mariners, and 

marine information broadcasts. 


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