Federal Register / Vol. 88, No. 190 / Tuesday, October 3, 2023 / Proposed Rules 68031 

62. Kaplan, S., ‘‘Trump Administration 

Says Some Coronavirus Tests Can Bypass 

F.D.A. Scrutiny,’’ New York Times, August 

24, 2020. Available at https://

www.nytimes.com/2020/08/21/health/ 

coronavirus-tests-fda.html. 

63. Baumann, J., ‘‘Virus Testing Push 

Leaves FDA Lab Oversight in ‘a Bizarre 

Limbo,’’’ Bloomberg Law, August 26, 2020. 

Available at https://news.bloomberglaw.com/ 

pharma-and-life-sciences/virus-testing-pushleaves-fda-lab-oversight-in-a-bizarre-limbo. 

64. Howard, J., ‘‘HHS Withdraws Trump 

Administration Policy That Limited FDA 

Review of Certain Covid-19 Tests,’’ CNN, 

November 15, 2021. Available at https://

www.cnn.com/2021/11/15/health/covid-labtests-hhs-withdraws-policy-bn/index.html. 

65. Fortune, ‘‘Fortune 500—The Largest 

Companies in the U.S. by Revenue,’’ 2023. 

Available at https://fortune.com/ranking/ 

fortune500/. 

* 66. FDA, ‘‘Compliance Program Guidance 

Manual 7341.002; Inspection of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps).’’ Available at https://

www.fda.gov/media/73949/download. 

* 67. FDA, ‘‘Compliance Program Guidance 

Manual 7342.002; Inspection of Source 

Plasma Establishments, Brokers, Testing 

Laboratories, and Contractors,’’ January 31, 

2019. Available at https://www.fda.gov/ 

media/80179/download. 

* 68. Government Accountability Office, 

‘‘COVID–19: FDA Took Steps to Help Make 

Tests Available; Policy for Future Public 

Health Emergencies Needed,’’ May 2022. 

Available at https://www.gao.gov/assets/gao22-104266.pdf. 

* 69. ‘‘It Has Come to Our Attention’’ Letter 

to MD Biosciences re: the Zika Virus RNA by 

RT–PCR Assay (March 4, 2016). Available at 

https://public4.pagefreezer.com/browse/ 

FDA/22-02-2023T10:21/https://www.fda.gov/ 

media/96214/download. 

* 70. ‘‘It Has Come to Our Attention’’ Letter 

to First Diagnostic Corp. re: ATFirst One Step 

Zika Antibody Test (March 10, 2016). 

Available at https://public4.pagefreezer.com/ 

content/FDA/04-10-2022T10:19/https://

www.fda.gov/media/96739/download. 

* 71. FDA, ‘‘Direct-to-Consumer Tests,’’ 

December 20, 2019, available at https://

www.fda.gov/medical-devices/in-vitrodiagnostics/direct-consumer-tests (last 

accessed on March 9, 2023). 

* 72. Untitled Letter to Interleukin 

Genetics, Inc. (November 4, 2015). Available 

at https://public4.pagefreezer.com/browse/ 

FDA/22-02-2023T10:21/https://www.fda.gov/ 

media/94365/download. 

* 73. Untitled Letter to Pathway Genomics, 

Inc. (September 21, 2015). Available at 

https://public4.pagefreezer.com/browse/ 

FDA/30-12-2022T07:46/https://www.fda.gov/ 

media/93493/download. 

* 74. Transcript of the Molecular and 

Clinical Genetics Panel meeting, March 8, 

2011. Available at https://wayback.archiveit.org/7993/20170404140959/https://

www.fda.gov/downloads/ 

AdvisoryCommittees/CommitteesMeeting

Materials/MedicalDevices/MedicalDevices

AdvisoryCommittee/Molecularand

ClinicalGeneticsPanel/UCM249857.pdf. 

* 75. Transcript of the Molecular and 

Clinical Genetics Panel meeting, March 9, 

2011. Available at https://wayback.archiveit.org/7993/20170404141000/https:/ 

www.fda.gov/downloads/Advisory

Committees/CommitteesMeetingMaterials/ 

MedicalDevices/ 

MedicalDevicesAdvisoryCommittee/ 

MolecularandClinicalGeneticsPanel/ 

UCM249858.pdf. 

76. Bradley, P.L., J.S. Dickey, J.D. Levin, et 

al., ‘‘Complex Clinical Laboratory Tests Can 

Benefit From Design Controls,’’ Health 

Affairs Forefront, June 3, 2022. Available at 

https://www.healthaffairs.org/do/10.1377/ 

forefront.20220601.318288. 

* 77. FDA, ‘‘510(k) Third Party Review 

Program,’’ August 19, 2022. Available at 

https://www.fda.gov/medical-devices/ 

premarket-submissions-selecting-andpreparing-correct-submission/510k-thirdparty-reviewprogram(lastaccessedonSeptember22,2023). 

List of Subjects in 21 CFR Part 809 

Labeling, Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, FDA proposes to 

amend 21 CFR part 809 as follows: 

PART 809—IN VITRO DIAGNOSTIC 

PRODUCTS FOR HUMAN USE 

■ 1. The authority citation for part 809 

is revised to read as follows: 

Authority: 21 U.S.C. 321(h)(1), 331, 351, 

352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 

371, 372, 374, 381. 

■ 2. In § 809.3, revise the last sentence 

of paragraph (a) to read as follows: 

§ 809.3 Definitions. 

(a) * * * These products are devices 

as defined in section 201(h)(1) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) and may also be biological 

products subject to section 351 of the 

Public Health Service Act, including 

when the manufacturer of these 

products is a laboratory. 

* * * * * 

Dated: September 27, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2023–21662 Filed 9–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2023–0530] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Long Creek, Nassau County, NY 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

temporarily modify the operating 

schedule that governs the Loop Parkway 

Bridge across Long Creek, mile 0.7, 

Nassau County, NY. The bridge owner, 

New York State Department of 

Transportation (NYSDOT), submitted a 

request to operate the bridge under 

single leaf openings to perform bridge 

deck replacement. We invite your 

comments on this proposed rulemaking. 

DATES: Comments and related material 

must reach the Coast Guard on or before 

November 2, 2023. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2023–0530 using Federal Decision 

Making Portal at https://

www.regulations.gov. 

See the ‘‘Public Participation and 

Request for Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this proposed 

rule, call or email Ms. Stephanie E. 

Lopez, First Coast Guard District, 

Project Officer, telephone 212–514– 

4335, email Stephanie.E.Lopez@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

OMB Office of Management and Budget 

NPRM Notice of proposed rulemaking 

(advance, supplemental) 

§ Section 

U.S.C. United States Code 

NYSDOT New York State Department of 

Transportation 

II. Background, Purpose, and Legal 

Basis 

The Loop Parkway Bridge across Long 

Creek, mile 0.7, Nassau County, NY, has 

a vertical clearance of 21 feet at mean 

high water and a horizontal clearance of 

75.5 feet at mean high water. Waterway 


ddrumheller on DSK120RN23PROD with PROPOSALS1
68032 Federal Register / Vol. 88, No. 190 / Tuesday, October 3, 2023 / Proposed Rules 

users include recreational and 

commercial vessels, including fishing 

vessels. 

The existing drawbridge operating 

regulations are listed at 33 CFR 

117.799(f). NYSDOT is requesting a 

temporary rulemaking to operate under 

single leaf openings while they perform 

bridge deck replacements. NYSDOT has 

reached out to local mariners and 

notified them of the proposed temporary 

rulemaking as well as outlined an 

alternate route for larger vessels that 

may not be able to make passage under 

the bridge with single leaf openings. 

III. Discussion of Proposed Rule 

The Loop Parkway Bridge will 

continue to operate under its regular 

operating schedule found in 33 CFR 

117.799(f). However, this proposed rule 

will allow the bridge to operate under 

single leaf openings from September 15, 

2023, through May 15, 2024. For vessels 

that are too large for single leaf 

openings, NYSDOT has set an alternate 

route. Vessels that can pass without 

requesting a bridge opening may do so. 

NYSDOT has reached phase 2 of the 

project which requires replacing the 

bridge deck. The reason for this request 

is to allow the project to progress while 

minimizing impact on mariners. 

IV. Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on these statutes and Executive 

orders. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This proposed rule has not been 

designated a ‘‘significant regulatory 

action,’’ under section 3(f) of Executive 

Order 12866, as amended by Executive 

Order 14094 (Modernizing Regulatory 

Review). This NPRM has not been 

designated a ‘‘significant regulatory 

action,’’ under Executive Order 12866. 

Accordingly, the NPRM has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This regulatory action determination 

is based on the ability of vessels to still 

transit the bridge under singe leaf 

openings or may transit through an 

alternate route. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 1980 

(RFA), 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this proposed rule would not 

have a significant economic impact on 

a substantial number of small entities. 

While some owners or operators of 

vessels intending to transit the bridge 

may be small entities, for the reasons 

stated in section IV.A. above, this 

proposed rule would not have a 

significant economic impact on any 

vessel owner or operator. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this proposed rule would have 

a significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rulemaking would economically 

affect it. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this proposed rule. If the 

rule would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please contact the person 

listed in the FOR FURTHER INFORMATION

CONTACT section. The Coast Guard will 

not retaliate against small entities that 

question or complain about this 

proposed rule or any policy or action of 

the Coast Guard. 

C. Collection of Information 

This proposed rule would call for no 

new collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132 

(Federalism), if it has a substantial 

direct effect on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. We have analyzed 

this proposed rule under that order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this proposed rule does not have 

tribal implications under Executive 

Order 13175 (Consultation and 

Coordination with Indian Tribal 

Governments) because it would not 

have a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

If you believe this proposed rule has 

implications for federalism or Indian 

tribes, please contact the person listed 

in the FOR FURTHER INFORMATION

CONTACT section. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this 

proposed rule will not result in such an 

expenditure, we do discuss the effects of 

this proposed rule elsewhere in this 

preamble. 

F. Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01, 

Rev.1, associated implementing 

instructions, and Environmental 

Planning Policy COMDTINST 5090.1 

(series), which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f). The 

Coast Guard has determined that this 

action is one of a category of actions that 

do not individually or cumulatively 

have a significant effect on the human 

environment. This proposed rule 

promulgates the operating regulations or 

procedures for drawbridges. Normally 

such actions are categorically excluded 

from further review, under paragraph 

L49, of Chapter 3, Table 3–1 of the U.S. 

Coast Guard Environmental Planning 

Implementation Procedures. 

Neither a Record of Environmental 

Consideration nor a Memorandum for 

the Record are required for this 

proposed rule. We seek any comments 

or information that may lead to the 

discovery of a significant environmental 

impact from this proposed rule. 

V. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking and 

will consider all comments and material 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 190 / Tuesday, October 3, 2023 / Proposed Rules 68033 

received during the comment period. 

Your comment can help shape the 

outcome of this rulemaking. If you 

submit a comment, please include the 

docket number for this rulemaking, 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. 

Submitting comments. We encourage 

you to submit comments through the 

Federal Decision Making Portal at 

https://www.regulations.gov. To do so, 

go to https://www.regulations.gov, type 

USCG–2023–0530 in the search box and 

click ‘‘Search.’’ Next, look for this 

document in the Search Results column, 

and click on it. Then click on the 

Comment option. If your material 

cannot be submitted using https://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. 

Viewing material in docket. To view 

documents mentioned in this proposed 

rule as being available in the docket, 

find the docket as described in the 

previous paragraph, and then select 

‘‘Supporting & Related Material’’ in the 

Document Type column. Public 

comments will also be placed in our 

online docket and can be viewed by 

following instructions on the https://

www.regulations.gov Frequently Asked 

Questions web page. Also, if you click 

on the ‘‘Dockets’’ tab and then the 

proposed rule, you should see a 

‘‘Subscribe’’ option for email alerts. 

Selecting this option will enable 

notifications when comments are 

posted, or if/when a final rule is 

published. 

We review all comments received, but 

we will only post comments that 

address the topic of the proposed rule. 

We may choose not to post off-topic, 

inappropriate, or duplicate comments 

that we receive. 

Personal information. We accept 

anonymous comments. Comments we 

post to https://www.regulations.gov will 

include any personal information you 

have provided. For more about privacy 

and submissions in response to this 

document, see DHS’s eRulemaking 

System of Records notice (85 FR 14226, 

March 11, 2020). 

List of Subjects in 33 CFR Part 117 

Bridges. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; 33 CFR 1.05–1; 

and DHS Delegation No. 00170.1, Revision 

No. 01.3. 

■ 2. Section 117.799 is amended as 

follows: 

■ a. Stay paragraph (f). 

■ b. Add paragraph (j). 

The addition reads as follows: 

§ 117.799 Long Island, New York Inland 

Waterway from East Rockaway Inlet to 

Shinnecock Canal. 

* * * * * 

(j) The draw of the Loop Parkway 

Bridge across Long Creek, mile 0.7, shall 

operate on single leaf openings until 

May 15, 2024. The draw will open for 

commercial vessels engaged in 

commerce and shall open Monday thru 

Friday from 6:20 a.m. to 9:50 a.m. and 

3:20 p.m. to 7:20 p.m. on signal at 20 

and 50 minutes after the hour, and on 

signal at all other times. For all other 

vessels, the draw shall open on Monday 

through Friday from 6:20 a.m. to 7:20 

p.m. on signal at 20 and 50 minutes 

after the hour, and the draw shall open 

on Saturday, Sunday, and Federal 

holidays from 7:20 a.m. to 8:20 p.m. on 

signal at 20 and 50 minutes after the 

hour, and on signal at all other times. 

Dated: August 21, 2023. 

J.W. Mauger, 

Rear Admiral, U.S. Coast Guard, Commander, 

First Coast Guard District. 

[FR Doc. 2023–21753 Filed 9–28–23; 4:15 pm] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2023–0532] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Sloop Channel, Nassau County, NY 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

temporarily modify the operating 

schedule that governs the Meadowbrook 

State Parkway Bridge, mile 12.8, across 

Sloop Channel, Nassau County, NY. The 

bridge owner, New York State 

Department of Transportation 

(NYSDOT), submitted a request to 

operate the bridge under single leaf 

openings to perform bridge deck 

replacement. We invite your comments 

on this proposed rulemaking. 

DATES: Comments and relate material 

must reach the Coast Guard on or before 

November 2, 2023. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2023–0532 using Federal Decision 

Making Portal at https://

www.regulations.gov. 

See the ‘‘Public Participation and 

Request for Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this proposed 

rule, call or email Ms. Stephanie E. 

Lopez, First Coast Guard District, 

Project Officer, telephone 212–514– 

4335, email Stephanie.E.Lopez@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations [Delete/Add 

Any Abbreviations Not Used/Used in 

This Document] 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

OMB Office of Management and Budget 

NPRM Notice of Proposed Rulemaking 

(Advance, Supplemental) 

§ Section 

U.S.C. United States Code 

NYSDOT New York State Department of 

Transportation 

II. Background, Purpose and Legal 

Basis 

The Meadowbrook State Parkway 

Bridge across Sloop Channel, mile 12.8, 

Nassau County, NY, has a vertical 

clearance of 21 feet at mean high water 

and a horizontal clearance of 75.5 feet 

at mean high water. Waterway users 

include recreational and commercial 

vessels, including fishing vessels. 

The existing drawbridge operating 

regulations are listed at 33 CFR 

117.799(h). NYSDOT is requesting a 

temporary rulemaking to operate under 

single leaf openings while they perform 

bridge deck replacements. NYSDOT has 

reached out to local mariners and 

notified them of the proposed temporary 

rulemaking as well as outlined an 

alternate route for larger vessels that 

may not be able to make passage under 

the bridge with single leaf openings. 

III. Discussion of Proposed Rule 

The Meadowbrook State Parkway 

Bridge will continue to operate under its 

regular operating schedule found in 33 

CFR 117.799(f). However, this proposed 

rule when made final would allow the 


ddrumheller on DSK120RN23PROD with PROPOSALS1