77062 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 26 

[Docket No. FDA–2024–N–4016] 

RIN 0910–AI92 

Revocation of Regulations Regarding 

the Mutual Recognition of 

Pharmaceutical Good Manufacturing 

Practice Reports, Medical Device 

Quality System Audit Reports, and 

Certain Medical Device Product 

Evaluation Reports: United States and 

The European Community 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

proposing to revoke the regulations 

entitled ‘‘Mutual Recognition of 

Pharmaceutical Good Manufacturing 

Practice Reports, Medical Device 

Quality System Audit Reports, and 

Certain Medical Device Product 

Evaluation Reports: United States and 

The European Community.’’ FDA is 

proposing this action because the 

existing regulations have been 

superseded in part by the ‘‘United 

States-European Union Amended 

Sectoral Annex for Pharmaceutical 

Good Manufacturing Practices (GMPs)’’ 

that entered into force in 2017 (2017 

Amended Pharmaceutical Annex), are 

outdated, do not reflect current Agency 

practice, and are unnecessary. 

DATES: Either electronic or written 

comments on the proposed rule must be 

submitted by November 19, 2024. 

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 

November 19, 2024. 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 

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– 

2024–N–4016 for ‘‘Revocation of Mutual 

Recognition of Pharmaceutical Good 

Manufacturing Practice Reports, 

Medical Device Quality System Audit 

Reports, and Certain Medical Device 

Product Evaluation Reports: United 

States and The European Community.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Perlesta Hollingsworth, Office of 

Regulatory Affairs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20903, 240– 

402–5874, Perlesta.Hollingsworth@

fdahhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Acronyms 

III. Background 

A. Introduction 

B. Need for Regulation 

IV. Legal Authority 

V. Description of the Proposed Rule 

VI. Proposed Effective Date 

VII. Preliminary Economic Analysis of 

Impacts 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA proposes to revoke the 

regulations at part 26 (21 CFR part 26), 

which substantially reflect certain 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 77063 

provisions of the ‘‘Agreement on Mutual 

Recognition Between the United States 

of America and the European 

Community’’ that was signed in 1998 

(1998 MRA). These regulations have 

been superseded in part by the 2017 

Amended Pharmaceutical Annex, do 

not reflect current Agency practice, and 

are unnecessary. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule would revoke part 

26—Mutual Recognition of 

Pharmaceutical Good Manufacturing 

Practice Reports, Medical Device 

Quality System Audit Reports, and 

Certain Medical Device Product 

Evaluation Reports: United States and 

The European Community. This part 

substantially reflects the 1998 MRA 

between the United States and the 

European Community that was created 

to better utilize the inspectional 

resources of each signatory by 

recognizing one another’s inspection 

reports. Part 26 consists of 3 subparts: 

Subpart A—Specific Sector Provisions 

for Pharmaceutical Good Manufacturing 

Practices (which substantially reflects 

the 1998 MRA’s ‘‘pharmaceutical 

sectoral annex’’), Subpart B—Specific 

Sector Provisions for Medical Devices 

(which substantially reflects the 1998 

MRA’s ‘‘medical device sectoral 

annex’’), and Subpart C—‘‘Framework’’ 

Provisions (which substantially reflects 

the 1998 MRA’s ‘‘umbrella’’ agreement 

that contained general provisions 

applicable to the operation of all of the 

sectoral annexes). 

C. Legal Authority 

FDA is taking this action under the 

general administrative provisions of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). We discuss our legal 

authority in greater detail in part III. 

D. Costs and Benefits 

Because this proposed rule would not 

impose any additional regulatory 

burdens, this regulation is not 

anticipated to result in any compliance 

costs and the economic impact is 

expected to be minimal. 

II. Table of Abbreviations/Acronyms 

Abbreviation/ 

acronym What it means 

EC .................... European Community. 

E.O ................... Executive Order. 

FD&C Act ......... Federal Food, Drug, and Cosmetic Act. 

GMP ................. Good Manufacturing Practice. 

MRA ................. Mutual Recognition Agreement. 

III. Background 

A. Introduction 

Part 26 was issued in response to the 

1998 MRA between the United States 

and the European Community (EC), 

whereby both parties would recognize 

certain drug and device inspections/ 

evaluation reports of the other, in order 

to more effectively allocate limited 

inspection resources (Mutual 

Recognition of Pharmaceutical Good 

Manufacturing Practice Inspection 

Reports, Medical Device Quality System 

Audit Reports, and Certain Medical 

Device Product Evaluation Reports 

Between the United States and the 

European Community, 63 FR 60122 at 

60141 (November 6, 1998)). Subparts A 

and B of part 26 substantially reflect the 

1998 MRA’s pharmaceutical and 

medical device sectoral annexes, 

respectively. Subpart C of part 26 sets 

forth the framework provisions by 

which subparts A and B can be 

implemented. Subpart A governs ‘‘the 

exchange between the parties and 

normal endorsement by the receiving 

regulatory authority of official 

[pharmaceutical] good manufacturing 

practices (GMP) inspection reports[.]’’ 

(21 CFR 26.2) Subpart B specifies ‘‘the 

conditions under which a party will 

accept the results of quality systemrelated evaluations and inspections and 

premarket evaluations of the other party 

with regard to medical devices as 

conducted by listed conformity 

assessment bodies (CAB’s) and to 

provide for other related cooperative 

activities.’’ (21 CFR 26.31(a)) 

The pharmaceutical sectoral annex to 

the 1998 MRA was superseded by the 

2017 Amended Pharmaceutical Annex 

(https://www.fda.gov/internationalprograms/international-arrangements/ 

mutual-recognition-agreements-mra). 

The 2017 Amended Pharmaceutical 

Annex included new terms, rendering 

Subpart A obsolete. The medical device 

sectoral annex was not addressed in the 

2017 Amended Pharmaceutical Annex, 

but since the 1998 MRA went into 

effect, it has never been fully 

implemented. As other mechanisms 

(e.g., Medical Device Single Audit 

Program) now exist for mutual 

recognition with Europe with respect to 

medical device inspections, Subpart B is 

no longer necessary. 

Moreover, we do not believe it is 

required or would be beneficial for us to 

issue regulations that substantially 

reflect the 2017 Amended 

Pharmaceutical Annex with the 

European Union. The 2017 Amended 

Pharmaceutical Annex is in force and 

has been successfully implemented 

without regulations that substantially 

reflect it. The same is true for the MRAs 

that FDA entered into subsequently 

with Switzerland and the United 

Kingdom (https://www.fda.gov/ 

international-programs/internationalarrangements/mutual-recognitionagreements-mra). FDA’s proposed 

revocation of part 26 should not be 

interpreted as FDA retreating from our 

commitment to working with our 

foreign counterparts, including through 

mutual recognition agreements, to 

achieve greater efficiencies and increase 

our inspectional reach. 

B. Need for Regulation 

The Agency believes the regulations 

in part 26 should be revoked because 

they have been superseded in part by 

the 2017 Amended Pharmaceutical 

Annex, do not reflect current Agency 

practice, and are unnecessary. 

IV. Legal Authority 

We are issuing this proposed rule 

under the drugs, medical devices, and 

general administrative provisions of the 

FD&C Act (21 U.S.C. 321, 331, 351, 352, 

355, 360, 360b, 360c, 360d, 360e, 360f, 

360g, 360h, 360i, 360j, 360l, 360m, 371, 

374, 381, 382, 383, 384e, and 393) and 

under certain provisions of the Public 

Health Service Act (42 U.S.C. 216, 241, 

242l, 262, 264, and 265). Under section 

701(a) of the FD&C Act (21 U.S.C. 

371(a)), FDA has the authority to issue 

regulations, and under section 809 of 

the FD&C Act (21 U.S.C. 384e), FDA has 

the authority to ‘‘enter into 

arrangements and agreements with a 

foreign government or an agency of a 

foreign government to recognize the 

inspection of foreign establishments 

registered under section 510(i) in order 

to facilitate preapproval or risk-based 

inspections in accordance with the 

schedule established in paragraph (2) or 

(3) of section 510(h)[.]’’ 

V. Description of the Proposed Rule 

The proposed rule revokes part 26, 

which substantially reflects a 1998 

agreement between the United States 

and the EC created to better utilize the 

inspectional resources of each signatory 

by recognizing one another’s inspection 

reports. Revocation would eliminate 

regulations that have been superseded 

in part by the 2017 Amended 

Pharmaceutical Annex, do not reflect 

current Agency practice, and are 

unnecessary. 

FDA is proposing this action because 

the pharmaceutical sectoral annex to the 

1998 MRA which subpart A 

substantially reflects has been 

superseded by the 2017 Amended 

Pharmaceutical Annex, and the medical 

device sectoral annex to the 1998 MRA, 


ddrumheller on DSK120RN23PROD with PROPOSALS1
77064 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 

which subpart B substantially reflects, 

was never fully implemented. Subpart C 

contains general provisions applicable 

to both subparts A and B that will be 

unnecessary once subparts A and B are 

revoked. 

VI. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposed rule become 

effective 30 days after the date of its 

publication in the Federal Register. 

VII. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 14904, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866 section 3(f)(1) (as amended by 

Executive Order 14094) if they ‘‘have an 

annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator [of the Office of 

Information and Regulatory Affairs 

(OIRA)] for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this proposed rule 

is not a significant regulatory action 

under Executive Order 12866 section 

3(f)(1). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because this proposed rule does not add 

any new regulatory burden on the 

pharmaceutical or medical device 

industries, we propose to certify that the 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

impacts, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $183 

million, using the most current (2023) 

Implicit Price Deflator for the Gross 

Domestic Product. This proposed rule 

would not result in an expenditure in 

any year that meets or exceeds this 

amount. 

We believe industry will maintain 

their current practices following the 

removal of part 26. FDA will also 

maintain its current practices, similarly 

generating no quantifiable costs or cost 

savings. Therefore, we expect this 

proposed rule to be cost neutral. Table 

1 summarizes the estimated benefits and 

costs of the proposed rule, if finalized. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year .................. $0 

0 

$0 

0 

$0 

0 

2024 

2024 

7 

3 

10 

10 

Annualized Quantified .......................................... ..................

..................

..................

..................

..................

..................

..................

..................

..................

..................

..................

..................

Qualitative ............................................................ Avoid confusion created by outdated 

and unnecessary regulations that do 

not reflect current Agency practice 

Costs: 

Annualized Monetized millions/year .................... 0 

0 

0 

0 

0 

0 

2024 

2024 

7 

3 

10 

10 

Qualified reduction in inspection reports reporting 

costs per industry. Affected firms would not 

incur costs to develop and 

submit inspection reports. 

Annualized Quantified .......................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ............................................................

Transfers: 

Federal Annualized Monetized millions/year ....... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ............................................................... From: To: 

Other Annualized Monetized millions/year .......... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ............................................................... From: To: 

Effects: 

State, Local or Tribal Government: No estimated effect. 

Small Business: No estimated effect. 

Wages: No estimated effect. 

Growth: No estimated effect. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 77065 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule (Ref. 1) and at https://www.fda.gov/ 

about-fda/economics-staff/regulatoryimpact-analyses-ria. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.31(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects 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. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have substantial direct effects 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. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

XII. Reference 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m. Monday through Friday; it is 

also available electronically at https://

www.regulations.gov. Although FDA 

verified the website addresses in this 

document, please note that websites are 

subject to change over time. 

1. FDA/Economics Staff, ‘‘Revocation of 

Regulations Regarding the Mutual 

Recognition of Pharmaceutical Good 

Manufacturing Practice Reports, Medical 

Device Quality System Audit Reports, 

and Certain Medical Device Product 

Evaluation Reports: United States and 

The European Community Preliminary 

Regulatory Impact Analysis, Preliminary 

Regulatory Flexibility Analysis, 

Unfunded Mandates Reform Act 

Analysis,’’ 2020. (Available at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm.) 

List of Subjects in 21 CFR Part 26 

Animal, Animal drugs, Biologics, 

Drugs, Exports, Imports. 

For reasons stated in the preamble, 

and under the authority of 21 U.S.C. 393 

and delegated to the Commissioner of 

Food and Drugs, FDA proposes to 

remove 21 CFR part 26. 

Dated: September 12, 2024. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2024–21559 Filed 9–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 3 

[Docket ID: DoD–2024–OS–0099] 

RIN 0790–AK98 

Transactions Other Than Contracts, 

Grants, or Cooperative Agreements for 

Prototype Projects; Correction 

AGENCY: Office of the Under Secretary of 

Defense for Acquisition and 

Sustainment (OUSD(A&S)), Department 

of Defense (DoD). 

ACTION: Proposed rule; correction. 

SUMMARY: On September 4, 2024, the 

DoD published a proposed rule titled 

Transactions Other Than Contracts, 

Grants, or Cooperative Agreements for 

Prototype Projects. Subsequent to 

publication of the proposed rule, DoD 

discovered that the docket identifier in 

the published proposed rule was 

incorrect. All other information in the 

September 4, 2024, remains the same. 

DATES: This correction is effective on 

September 20, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Toppings, 571–372–0485. 

SUPPLEMENTARY INFORMATION: 

Correction 

In proposed rule FR Doc. 2024–19457, 

published in the Federal Register on 

September 4, 2024 (89 FR 71865) make 

the following correction: 

On page 71865, in the first column, in 

the document heading, the docket 

number ‘‘Docket ID: DoD–2021–OS– 

0071’’ is corrected to read ‘‘Docket ID: 

DoD–2024–OS–0099’’. 

Dated: September 17, 2024. 

Aaron T. Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2024–21551 Filed 9–19–24; 8:45 am] 

BILLING CODE 6001–FR–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[WC Docket Nos. 12–375, 23–62; FCC 24– 

75; FR ID 237560] 

Incarcerated People’s Communication 

Services; Implementation of the Martha 

Wright-Reed Act; Rates for Interstate 

Inmate Calling Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Federal Communications 

Commission (Commission) seeks 

additional comment on establishing 

permanent rate caps for video 

incarcerated people’s communications 

services (IPCS) that are just and 

reasonable, and will fairly compensate 

IPCS providers, including comment on 

the video IPCS marketplace and the 

types of data needed to support its 

efforts to adopt permanent video IPCS 

rate caps in the future. It also seeks 

comment on the possibly of further 

disaggregating the very small jail rate 

tier and the types of cost or other data 

that would identify any additional 

distinctions within this rate tier. The 

Commission seeks comment on its 

authority to address quality of service 

issues raised in this proceeding and 

whether it should develop minimum 

Federal quality of service standards. It 

again seeks comment on whether to 

expand the definitions of ‘‘Prison’’ and 

‘‘Jail’’ to capture the full universe of 

confinement facilities and specifically, 

the costs providers incur in providing 

service to confinement facilities that are 

not correctional institutions. It also 

seeks comment on whether to 


ddrumheller on DSK120RN23PROD with PROPOSALS1