77200 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 

(1) The intended use of the device 

must specify: 

(i) The Red Blood Cell components 

that can be processed and stored 

including acceptable anticoagulants and 

additive solutions; 

(ii) The hold time after Red Blood Cell 

component collection; 

(iii) The processing capacity (volume) 

of the device; and 

(iv) The storage temperature and 

dating period of processed Red Blood 

Cell components. 

(2) Studies must demonstrate that the 

device is biocompatible and include 

detailed documentation of the 

biocompatibility evaluation. 

(3) Performance testing and 

nonclinical studies must include a 

detailed study of leached materials 

extracted under conditions similar to 

clinical usage of the device, and a 

toxicologic risk assessment of those 

extracted or leached materials. 

(4) Performance testing must support 

sterility of the device and include 

sterilization validation, endotoxin 

testing, and container closure integrity 

evaluation. 

(5) Nonclinical and clinical studies 

must include evaluation of red blood 

cell quality throughout the duration of 

storage based on in vitro and in vivo 

studies, including hemolysis and red 

blood cell survival and recovery. 

(6) Performance studies must include: 

(i) Detailed documentation of 

functional and mechanical testing, 

including evaluation of oxygen and, if 

applicable, carbon dioxide levels during 

Red Blood Cell components storage; and 

(ii) Detailed documentation of device 

shelf-life testing demonstrating 

continued sterility, package integrity, 

and functionality over the identified 

shelf life. 

(7) The labeling must include a 

contraindication against processing Red 

Blood Cell components collected from 

donors with hemoglobin S. 

Dated: November 3, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24717 Filed 11–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2023–0783] 

Special Local Regulations; OPA World 

Championships; Gulf of Mexico; 

Englewood, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

special local regulations for the OPA 

World Championships to provide for the 

safety of life on navigable waterways 

during this event. Our regulation for 

marine events within the Seventh Coast 

Guard District identifies the regulated 

area for this event in Englewood Beach, 

FL. During the enforcement periods, the 

operator of any vessel in the regulated 

area must comply with directions from 

the Patrol Commander or any 

designated representative. 

DATES: The regulations in 33 CFR 

100.703 will be enforced daily from 8 

a.m. until 6 p.m. on November 18, 2023, 

through November 19, 2023, for the 

location identified in Item 8 in table 1 

to § 100.703. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call or 

email Marine Science Technician First 

Class Mara Brown, Sector St. Petersburg 

Prevention Department, Coast Guard; 

telephone 813–228–2191, email 

mara.j.brown@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulations in 33 CFR 100.703 for the 

OPA World Championships identified in 

Table 1 to § 100.703, Item No. 8, from 

8 a.m. until 6 p.m., on November 18, 

2023, through November 19, 2023. This 

action is being taken to provide for the 

safety of life on navigable waterways 

during this event. Our regulation for 

recurring marine events, Sector St. 

Petersburg, § 100.703, Table 1 to 

§ 100.703, Item No. 8, specifies the 

locations of the regulated area for the 

OPA World Championships which 

encompasses portions of the Gulf of 

Mexico near Englewood, FL. During the 

enforcement periods, as reflected in 

§ 100.703(c), if you are the operator of 

a vessel in the regulated area you must 

comply with directions from the Patrol 

Commander or any designated 

representative. 

In addition to this notice of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification of this enforcement period 

via the Local Notice to Mariners, marine 

information broadcasts, or both. 

Dated: November 2, 2023. 

Michael P. Kahle, 

Captain, U.S. Coast Guard, Captain of the 

Port St. Petersburg. 

[FR Doc. 2023–24787 Filed 11–8–23; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2023–0883] 

Safety Zone; Military Ocean Terminal 

Concord Safety Zone, Suisun Bay, 

Military Ocean Terminal Concord, CA 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a safety zone in the navigable waters of 

Suisun Bay, off Concord, CA, in support 

of explosive on-loading to Military 

Ocean Terminal Concord (MOTCO) on 

November 13, 2023, through November 

20, 2023. This safety zone is necessary 

to protect personnel, vessels, and the 

marine environment from potential 

explosion within the explosive arc. The 

safety zone is open to all persons and 

vessels for transitory use, but vessel 

operators desiring to anchor or 

otherwise loiter within the safety zone 

must obtain the permission of the 

Captain of the Port San Francisco or a 

designated representative. All persons 

and vessels operating within the safety 

zone must comply with all directions 

given to them by the Captain of the Port 

San Francisco or a designated 

representative. 

DATES: The regulations in 33 CFR 

165.1198 will be enforced from 12:01 

a.m. on November 13, 2023, until 11:59 

p.m. on November 20, 2023. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call, or 

email LT Abby Hamann, U.S. Coast 

Guard Sector San Francisco, Waterways 

Management Division, at 415–399–3585, 

SFWaterways@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone in 33 

CFR 165.1198 for the Military Ocean 

Terminal Concord, CA (MOTCO) 

regulated area from 12:01 a.m. on 

November 13, 2023, until 11:59 p.m. on 


ddrumheller on DSK120RN23PROD with RULES1