92128 Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 

B. Need and Uses 

This clearance covers the information 

that offerors and contractors must 

submit to comply with the following 

FAR requirements: 

1. FAR 15.407–2(e), Make-or-buy 

programs. When prospective contractors 

are required to submit proposed makeor-buy program plans for negotiated 

acquisitions, paragraph (e) requires the 

following information in their proposal: 

(a) A description of each major item 

or work effort; 

(b) Categorization of each major item 

or work effort as ‘‘must make,’’ ‘‘must 

buy,’’ or ‘‘can either make or buy’’; 

(c) For each item or work effort 

categorized as ‘‘can either make or buy,’’ 

a proposal either to ‘‘make’’ or to ‘‘buy’’; 

(d) Reasons for categorizing items and 

work efforts as ‘‘must make’’ or ‘‘must 

buy,’’ and proposing to ‘‘make’’ or to 

‘‘buy’’ those categorized as ‘‘can either 

make or buy’’; 

(e) Designation of the plant or 

division proposed to make each item or 

perform each work effort, and a 

statement as to whether the existing or 

proposed new facility is in or near a 

labor surplus area; 

(f) Identification of proposed 

subcontractors, if known, and their 

location and size status; 

(g) Any recommendations to defer 

make-or-buy decisions when 

categorization of some items or work 

efforts is impracticable at the time of 

submission; and 

(h) Any other information the 

contracting officer requires in order to 

evaluate the program. 

2. FAR 52.215–1(c)(2)(iv)— 

Authorized Negotiators. This provision 

requires firms offering supplies or 

services to the Government under 

negotiated solicitations to provide the 

names, titles, and telephone and 

facsimile numbers (and electronic 

addresses if available) of authorized 

negotiators to assure that discussions 

are held with authorized individuals. 

Contracting officers use this 

information during contract negotiations 

and it becomes part of the official 

contract file. 

3. FAR 52.215–9, Changes or 

Additions to Make-or-Buy Program. 

This clause requires the contractor to 

submit, in writing, for the contracting 

officer’s advance approval a notification 

and justification of any proposed change 

in the make-or-buy program 

incorporated in the contract. 

Contracting officers use the 

information collected regarding makeor-buy programs at FAR 15.407–2(e) and 

52.215–9 to ensure negotiation of 

reasonable contract prices, satisfactory 

performance, or implementation of 

socioeconomic policies. 

4. FAR 52.215–14—Integrity of Unit 

Prices. This clause requires offerors and 

contractors under negotiated 

solicitations and contracts to identify 

those supplies which they will not 

manufacture or to which they will not 

contribute significant value, if requested 

by the contracting officer or when 

contracting without adequate price 

competition. 

When a contract action is priced on 

the basis of a cost estimate, contracting 

officers use this information to 

determine whether the intrinsic value of 

an item has been distorted through 

allocation of overhead costs and 

whether such items should be 

considered for breakout. 

5. FAR 52.215–19—Notification of 

Ownership Changes. This clause 

requires contractors to notify the 

administrative contracting officer when 

the contractor becomes aware that a 

change in its ownership has occurred, or 

is certain to occur, that could result in 

changes in the valuation of its 

capitalized assets in the accounting 

records. 

The notification of ownership change 

enables the Government to adequately 

administer the cost principle at FAR 

31.205–52, Asset valuations resulting 

from business combinations, which 

addresses the allowability of certain 

costs resulting from asset valuations 

following business combinations. 

6. FAR 52.215–22, Limitations on 

Pass-Through Charges—Identification of 

Subcontract Effort. This provision 

requires offerors submitting a proposal 

for a contract, task order, or delivery 

order to provide the following 

information with their proposal: 

(a) The total cost of the work to be 

performed by the offeror, and the total 

cost of the work to be performed by each 

subcontractor; 

(b) If the offeror intends to 

subcontract more than 70 percent of the 

total cost of work to be performed, the 

amount of the offeror’s indirect costs 

and profit/fee applicable to the work to 

be performed by the subcontractor(s), 

and a description of the value added by 

the offeror as related to the work to be 

performed by the subcontractor(s); and 

(c) If any subcontractor proposed 

intends to subcontract to a lower-tier 

subcontractor more than 70 percent of 

the total cost of work to be performed, 

the amount of the subcontractor’s 

indirect costs and profit/fee applicable 

to the work to be performed by the 

lower-tier subcontractor(s) and a 

description of the added value provided 

by the subcontractor as related to the 

work to be performed by the lower-tier 

subcontractor(s). 

7. FAR 52.215–23, Limitations on 

Pass-Through Charges. This clause 

requires contractors to provide a 

description of the value added by the 

contractor or subcontractor, as 

applicable, as related to the subcontract 

effort if the effort changes from the 

amount identified in the proposal such 

that it exceeds 70 percent of the total 

cost of work to be performed. 

Contracting officers use the 

information collected at FAR 52.215–22 

and 52.215–23 to assess the value added 

by a contractor or subcontractor in 

relation to proposed, billed, or claimed 

indirect costs or profit/fee on work 

performed by a subcontractor. This 

information is required to ensure that 

pass-through charges under contracts 

and subcontracts are not excessive. 

C. Annual Burden 

Respondents: 122,097. 

Total Annual Responses: 139,074. 

Total Burden Hours: 43,027 (43,022 

reporting hours + 5 recordkeeping 

hours). 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0048, Certain Federal 

Acquisition Regulation Part 15 

Requirements. 

Janet Fry, 

Director, Federal Acquisition Policy Division, 

Office of Governmentwide Acquisition Policy, 

Office of Acquisition Policy, Office of 

Governmentwide Policy. 

[FR Doc. 2024–27314 Filed 11–20–24; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

510(k) Third Party Review Program and 

Third Party Emergency Use 

Authorization Review; Guidance for 

Industry, Food and Drug 

Administration Staff, and Third Party 

Review Organizations; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘510(k) Third Party 


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Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 92129 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ This guidance provides FDA’s 

current thinking regarding the 510(k) 

Third Party (3P510k) Review Program 

and review of EUA requests by a third 

party review organization (3PEUA 

review). The 3P510k Review Program 

and 3PEUA review create an alternative 

process for manufacturers to seek 

review of 510(k) submissions and EUA 

requests to assist FDA in reviewing in 

a timely manner. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 21, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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 

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– 

2016–D–2565 for ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ 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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review’’ to the Office of Policy, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

5431, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2438, Silver Spring, 

MD 20993–0002, 301–796–6524. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

the ‘‘510(k) Third Party Review Program 

and Third Party Emergency Use 

Authorization (EUA) Review’’ guidance. 

This guidance updates the previously 

issued ‘‘510(k) Third Party Review 

Program’’ guidance to further clarify the 

3P510k Review Program and outline 

how FDA may use third party review 

organizations to conduct an initial 

review of EUA requests for all devices, 

including in vitro diagnostics, under 

section 564 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360bbb–3) and consistent with section 

565(i) of the FD&C Act (21 U.S.C. 

360bbb–4(i)). 

This guidance distinguishes FDA’s 

expectations for the 3P510k Review 

Program and for 3PEUA review; 

describes the factors FDA will use in 

determining device type eligibility for 

review by 3P510k Review 

Organizations; describes FDA’s 

expectations for third party review 

organizations when conducting 

substantial reviews of 510(k) 

submissions and EUA requests; outlines 

FDA’s process for the recognition, 

rerecognition, suspension, and 

withdrawal of recognition for 3P510k 

Review Organizations; and describes the 

expectations regarding compensation to 

third party review organizations. This 

guidance also outlines FDA’s current 

thinking on leveraging the International 

Medical Device Regulators Forum’s 

documents for the 3P510k Review 

Program. This guidance supersedes 

‘‘510(k) Third Party Review Program; 

Guidance for Industry, Food and Drug 

Administration Staff, and Third Party 

Review Organizations’’ issued on March 

12, 2020 (85 FR 14489). 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of December 21, 2023 (88 FR 


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92130 Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 

88395). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarifying the 

relationship between 510k Review 

Organizations and EUA Third Party 

Review Organizations, and conflicts of 

interest requirements for personnel of 

Third Party Review Organizations. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on 510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review. 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. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

GUI01500013 and complete title to 

identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

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 the following table have 

been approved by OMB: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

‘‘510(k) Third Party Review Program’’ ....................................... 510(k) Third Party Review Program ........................................... 0910–0375 

‘‘Requests for Feedback on Medical Device Submissions: The 

Pre-Submission Program and Meetings with Food and Drug 

Administration Staff’’.

Q-submissions ............................................................................ 0910–0756 

‘‘Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders’’.Emergency Use Authorization .................................................... 0910–0595 

‘‘Guidance for Industry and Food and Drug Administration 

Staff; Center for Devices and Radiological Health Appeals 

Processes’’.

CDRH Appeals Processes ......................................................... 0910–0738 

Dated: November 12, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–27085 Filed 11–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3609] 

Development of an Enhanced 

Systematic Process for the Food and 

Drug Administration’s Post-Market 

Assessment of Chemicals in Food; 

Public Meeting; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

notice of public meeting; request for 

comments, published in the Federal 

Register of August 12, 2024. In that 

notice, FDA announced a public 

meeting entitled ‘‘Development of an 

Enhanced Systematic Process for the 

Food and Drug Administration’s PostMarket Assessment of Chemicals in 

Food.’’ FDA hosted the public meeting 

on September 25, 2024, and is now 

extending the comment period to allow 

interested persons additional time to 

submit comments about approaches to 

systematic post-market assessment of 

chemicals in food. 

DATES: FDA is extending the comment 

period announced in the notice of 

public meeting; request for comments 

published August 12, 2024 (89 FR 

65633). Either electronic or written 

comments must be submitted by January 

21, 2025. 

ADDRESSES: You may submit comments 

as follows. 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 at the end of 

January 21, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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 


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