Federal Register / Vol. 88, No. 171 / Wednesday, September 6, 2023 / Notices 60951 

those patients receiving specific 

outpatient surgical or procedural 

services as well as evidence that the 

policy is based on. 

++ Section 482.41(b)(2), to address the 

requirements regarding Life Safety Code 

(LSC) waivers. 

++ Section 482.41(b)(7), to address the 

requirements regarding alcohol-based 

hand rub (ABHR) dispensers. 

In addition to the standards review, 

CMS also reviewed ACHC’s comparable 

survey processes, which were 

conducted as described in section III., of 

this notice, and yielded the following 

areas where, as of the date of this final 

notice, ACHC has completed revising its 

survey processes to demonstrate that it 

uses survey processes that are 

comparable to state survey agency 

processes by: 

• Revising the complaint response 

policies and processes to align with the 

State Operations Manual, Chapter 5 

guidance. ACHC revised its 

Administrative Review Offsite 

Investigation process to align with CMS’ 

triage process to track and trend for 

potential focus areas during the next 

onsite survey or complete an onsite 

complaint investigation. 

• Revising ACHC’s hospital 

accreditation process policies to include 

the applicable sections of the Health 

Care Facilities Code National Fire 

Protection Agency (NFPA 99) in 

accordance with section 482.41(c). 

• Ensuring that all hospital LSC 

surveyors have received comparable and 

adequate training or have sufficient 

experience to make them qualified to 

survey health care facilities for 

compliance with both the 2012 LSC and 

2012 NFPA 99 requirements. 

• Providing guidance and instruction 

to surveyors on determining the 

appropriate level of citation for LSC 

deficiencies. 

B. Term of Approval 

Based on our review and observations 

described in section III. and section V. 

of this final notice, we approve ACHC 

as a national accreditation organization 

for hospitals that request participation 

in the Medicare program. The decision 

announced in this final notice is 

effective September 25, 2023, through 

September 25, 2027 (4 years). In 

accordance with § 488.5(e)(2)(i) the term 

of the approval will not exceed 6 years. 

While ACHC has taken actions based 

on the findings annotated in section 

V.A., of this final notice, (Differences 

Between ACHC’s Standards and 

Requirements for Accreditation and 

Medicare Conditions and Survey 

Requirements) as authorized under 

§ 488.8, we will continue ongoing 

review of ACHC’s hospital processes to 

ensure full implementation and 

sustained compliance. In keeping with 

CMS’s initiative to increase AO 

oversight broadly and ensure that our 

requested revisions by ACHC are fully 

implemented, CMS expects more 

frequent review of ACHC’s activities in 

the future. 

VI. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or third 

party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Evell J. Barco Holland, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: August 31, 2023. 

Evell J. Barco Holland, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–19195 Filed 9–5–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1981] 

Drug Supply Chain Security Act 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs; Guidance for Industry; 

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 for industry entitled ‘‘DSCSA 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs.’’ This guidance identifies the 

standards necessary to facilitate 

adoption of secure, interoperable, 

electronic data exchange among the 

pharmaceutical distribution supply 

chain, and clarifies the trading partners, 

products, and transactions subject to 

such standards. This guidance finalizes 

the revised draft guidance of the same 

title, ‘‘DSCSA Standards for the 

Interoperable Exchange of Information 

for Tracing of Certain Human, Finished, 

Prescription Drugs,’’ issued in July 

2022, as required by the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 6, 2023. 

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– 

2014–D–1981 for ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 


lotter on DSK11XQN23PROD with NOTICES1
60952 Federal Register / Vol. 88, No. 171 / Wednesday, September 6, 2023 / Notices 

Human, Finished, Prescription Drugs.’’ 

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 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, or to 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Lysette Deshields, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3130, 

drugtrackandtrace@fda.hhs.gov; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘DSCSA Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs.’’ The FD&C Act, as amended by 

the Drug Supply Chain Security Act 

(DSCSA), outlines requirements for 

enhanced drug distribution security, 

which include the steps to achieve 

interoperable, electronic tracing of 

products at the package level. Section 

582(g)(1) of the FD&C Act (21 U.S.C. 

360eee–1(g)(1)) sets forth enhanced drug 

distribution security requirements for 

trading partners, including adherence to 

standards established by FDA for the 

exchange of transaction information and 

transaction statements in a secure, 

interoperable, electronic manner and 

the verification of product at the 

package level. Section 582(g)(1) of the 

FD&C Act states that these enhanced 

drug distribution security requirements 

go into effect on November 27, 2023. 

Additionally, section 582(h)(4)(A) of the 

FD&C Act specifies that FDA issue a 

guidance to identify and make 

recommendations with respect to the 

standards necessary for adoption in 

order to support the secure, 

interoperable, electronic data exchange 

among the pharmaceutical distribution 

supply chain that comply with a form 

and format developed by a widely 

recognized international standards 

development organization. 

In this guidance, FDA considered the 

standards established pursuant to 

sections 505D of the FD&C Act (21 

U.S.C. 355e). FDA also considered the 

standards established pursuant to 

section 582(a)(2) of the FD&C Act and 

described in the July 2022 revised draft 

guidance entitled ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs.’’ 

The pilot projects conducted per section 

582(j) of the FD&C Act also informed 

this guidance. 

In November 2014, FDA issued a draft 

guidance for industry, entitled ‘‘DSCSA 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs: How to Exchange Product 

Tracing Information.’’ In July 2022, FDA 

issued a revised draft guidance, entitled 

‘‘DSCSA Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs’’ (87 FR 40258), that updated the 

policies articulated in the 2014 draft 

guidance. This guidance finalizes the 

July 2022 revised draft guidance. FDA 

considered comments received on the 

revised draft guidance as the guidance 

was finalized. Changes were made to the 

guidance to improve clarity. This 

guidance finalizes the policy articulated 

in the July 2022 revised draft guidance 

to reflect the enhanced drug distribution 

security requirements in section 

582(g)(1) of the FD&C Act that will go 

into effect on November 27, 2023, 

including that only electronic methods 

of product tracing will be permitted and 

verification of product at the package 

level will be required, unless a waiver, 

exception, or exemption applies. This 

guidance is intended to also facilitate 

the creation of a uniform methodology 

for product tracing while ensuring the 

protection of confidential commercial 

information and trade secrets. FDA also 

published other guidances describing 

recommendations for enhanced drug 

distribution security, including the 

attributes necessary for enhanced 

product tracing and verification, which 

should be read in conjunction with this 

guidance (see FDA’s Drug Supply Chain 

Security Law and Policies web page at 

https://www.fda.gov/drugs/drug-supplychain-security-act-dscsa/drug-supplychain-security-act-law-and-policies). 

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 ‘‘DSCSA Standards 

for the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs.’’ 

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. 


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Federal Register / Vol. 88, No. 171 / Wednesday, September 6, 2023 / Notices 60953 

II. Paperwork Reduction Act of 1995 

This guidance includes information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). FDA intends to solicit public 

comment and obtain OMB approval for 

any information collections 

recommended in this guidance that are 

new or that would represent substantive 

or material modifications to those 

previously approved collections of 

information found in FDA regulations or 

guidance. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: August 31, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19182 Filed 9–5–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Assistant Secretary for 

Financial Resources; Statement of 

Organization, Functions, and 

Delegations of Authority 

AGENCY: Office of the Assistant 

Secretary for Financial Resources 

(ASFR), Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) is making 

several updates within the Office of the 

Assistant Secretary for Financial 

Resources (AM), the Immediate Office 

(AMM), the Office of Budget (AML), the 

Office of Finance (AMS), the Office of 

Grants (AMU), and the Office of 

Acquisitions (AMX), to better align 

office titles with office activities and to 

clearly delineate ASFR’s portfolio across 

its five components. 

FOR FURTHER INFORMATION CONTACT: 

Christine Jones, Deputy Assistant 

Secretary for Operations and 

Management, Office of the Assistant 

Secretary for Financial Resources, 

Hubert H. Humphrey Building, 200 

Independence Ave. SW, Room 514–G, 

Washington, DC 20201, (202) 690–7542. 

SUPPLEMENTARY INFORMATION: Part A 

(Office of the Secretary), Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (HHS) is being amended at 

Chapter AML, Office of Budget, as last 

amended at 74 FR 150 (39327) dated 

July 30, 2009; at Chapter AM, ASFR, as 

last amended at 74 FR 215 dated 

November 9, 2009; at Chapter AMS, 

Office of Finance, as last amended at 81 

FR 88249, dated December 7, 2016; at 

Chapter AMX, Office of Acquisitions, as 

last amended at 84 FR 20154, dated May 

8, 2019; at Chapter AMU, Office of 

Grants, as last amended 85 FR 81935, 

dated December 17, 2020; and at 

Chapter AMM, Immediate Office, as last 

amended at 86 FR 6354, dated January 

21, 2021. 

This notice realigns the Grants 

Quality Service Management Office 

(Grants QSMO) from the Immediate 

Office (AMM) to the Office of Grants 

(AMU); and compiles the 

responsibilities of ASFR into one 

Federal Register notice. All notices 

above are superseded by the following 

changes: 

(1) Chapter AM, Office of the Assistant 

Secretary for Financial Resources 

Section AM.00 Mission: The mission 

of the Office of the Assistant Secretary 

for Financial Resources is to advise the 

Secretary on all aspects of budget, 

grants, financial management, 

acquisitions, and Enterprise Risk 

Management and to provide direction 

for these activities throughout HHS. 

Section AM.10 Organization: The 

Office of the Assistant Secretary for 

Financial Resources is headed by the 

Assistant Secretary for Financial 

Resources, who reports to the Secretary, 

and accomplishes its work through its 

component offices: 

• Immediate Office (AMM) 

• Office of Budget (AML) 

• Office of Finance (AMS) 

• Office of Grants (AMU) 

• Office of Acquisitions (AMX) 

Section AM.20 Functions: The 

Assistant Secretary for Financial 

Resources has several formal and 

informal roles, including Chief 

Financial Officer (CFO), Chief 

Performance Improvement Officer (PIO), 

Chief Acquisition Officer (CAO), HHS 

audit follow-up official, and lead official 

for budget and Department-wide grants 

policy. The Assistant Secretary is also a 

close advisor to the Secretary on policy 

issues. 

(2) Chapter AMM, Immediate Office 

Section AMM.00 Mission: The 

Immediate Office is responsible for 

support, operations, and coordination 

required to execute the mission of the 

Office of the Assistant Secretary for 

Financial Resources (ASFR) and the 

implementation of HHS’s Enterprise 

Risk Management (ERM) capabilities. 

The Immediate Office also leads 

strategic and workforce development 

initiatives across ASFR. 

Section AMM.10 Organization: The 

Immediate Office is headed by the 

Deputy Assistant Secretary for 

Operations and Management, who 

reports to the Assistant Secretary for 

Financial Resources, and includes the 

following: 

• Division of Administrative Operations 

(AMM1) 

• Division of Enterprise Risk 

Management (AMM2) 

Section AMM.20 Functions: 

1. Division of Administrative 

Operations (AMM1): The Division: 

(a) Provides operational support for 

the ASFR. 

(b) Coordinates administrative and 

operational issues across ASFR. 

(c) Serves as the liaison with internal 

and external stakeholders regarding 

operational matters. 

(d) Leads activities that enhance 

ASFR’s management and operations. 

2. Division of Enterprise Risk 

Management (ERM) (AMM2): The 

Division: 

(a) Coordinates across HHS to 

establish, and communicate, and sustain 

HHS’s ERM vision, culture, strategy, 

and framework. 

(b) Designs, implements, and matures 

an ERM capability across HHS, 

including governance and community 

management. 

(c) Develops and shares tools, 

guidance, and best practices regarding 

ERM. 

(d) Provides technical assistance and 

direction to HHS Operating Divisions 

(OPDIVs) and Staff Divisions 

(STAFFDIVs) on implementing ERM. 

(e) Facilitates strategic initiatives 

across HHS’s risk portfolio of existing 

and emerging risks and opportunities, 

including guiding updates of the 

agency’s risk profile, and management’s 

prioritization of risks and opportunities. 

(f) Leads the Department’s efforts to 

meet the ERM requirements in OMB 

Circular A–123, ‘‘Management’s 

Responsibility for Enterprise Risk 

Management and Internal Control.’’ 

(g) Prepares reports, briefings, and 

makes recommendations to senior HHS 

leadership, OPDIVs, STAFFDIVs and 

other stakeholders on ERM related 

activities. 


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