80726 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 

Head Start’s participation in or use of 

coordinated funding, defined as the 

piecing together or combining of 

multiple funding sources. The data 

collection effort will consist of two 

surveys: (1) a census survey of Head 

Start program directors (of any grant 

recipient with a Head Start grant, Early 

Head Start grant, or both, or one of their 

delegate programs), and (2) a census 

survey of three state government 

administrative positions in each of the 

50 states and Washington, DC (the Head 

Start Collaboration Office Director, the 

administrator of state pre-kindergarten 

funds, and the administrator of the 

federal Child Care and Development 

Fund [CCDF]). The surveys will identify 

the most common approaches to 

coordinated funding; examine how 

these approaches relate to the provision 

of high-quality, comprehensive ECE 

services in Head Start programs; 

understand policy levers and conditions 

that influence Head Start programs’ 

decisions around and ability to 

coordinate funding; and document how 

participation in coordinated funding 

relates to Head Start’s engagement with 

other ECE programs and system efforts. 

The resulting insights will inform ACF 

about the prevalence of coordinated 

funding in Head Start, facilitators and 

challenges of coordinated funding for 

Head Start programs, and potential 

associations with program quality. They 

will also inform future case studies. 

Respondents: Head Start Program 

Directors, state-based Head Start 

Collaboration Office Directors, state 

administrators of state pre-kindergarten 

funds, and state-based administrators of 

federal CCDF. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Program Director Survey (Head Start Program Directors or financial administrators) ....................................................................................................... 1,642 1 .83 1,363 

ECE State Administrator Survey (State-based Head Start Collaboration Office Directors, administrators of state pre-kindergarten funds, state-based 

administrators of federal CCDF) .................................................................. 138 1 .67 93 

Estimated Total Annual Burden 

Hours: 1,456. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 9835; 42 U.S.C. 

9844. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–25607 Filed 11–17–23; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4806] 

Implementing Interoperable Systems 

and Processes for Enhanced Drug 

Distribution Security Requirements 

Under Section 582(g)(1) of the Federal 

Food, Drug, and Cosmetic Act; 

Establishment of a Public Docket; 

Request for Information and 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for information 

and comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

publishing this request for information 

to better understand the status of trading 

partners’ interoperable systems and 

processes for enhanced drug 

distribution security as required by the 

Food, Drug and Cosmetic Act (FD&C 

Act). 

DATES: Although you can comment at 

any time, submit either electronic or 

written information and comments by 

February 20, 2024 to ensure that the 

Agency considers your comments for 

potential future actions. 

ADDRESSES: You may submit 

information and comments 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’’). 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 80727 

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– 

2023–N–4806 for ‘‘Implementing 

Interoperable Systems and Processes for 

Enhanced Drug Distribution Security 

Requirements Under Section 582(g)(1) 

of the Federal Food, Drug, and Cosmetic 

Act.’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Venti, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4258, Silver Spring, 

MD 20993, 301–796–3130, 

drugtrackandtrace@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Supply Chain Security Act 

(DSCSA) (Pub. L. 113–54), enacted in 

2013, requires trading partners— 

primarily manufacturers, wholesale 

distributors, dispensers, and 

repackagers—to provide, receive and 

maintain documentation about 

prescription drugs and their chain of 

ownership from manufacturer to 

dispenser as the drugs are distributed in 

the U.S. supply chain. Before November 

27, 2023, trading partners could choose 

to provide and maintain such 

information either electronically or in 

paper format. However, beginning 

November 27, 2023, the DSCSA 

requirements changed to include 

requiring trading partners to provide, 

receive and maintain documentation 

about products and ownership only 

electronically using interoperable 

systems and processes. Under enhanced 

drug distribution security requirements 

in section 582(g)(1) of the FD&C Act (21 

U.S.C. 360eee–1(g)(1)), amongst other 

requirements, trading partners are 

required to: (1) exchange transaction 

information and transaction statements 

in a secure, interoperable, electronic 

manner for each package; (2) implement 

systems and processes for package-level 

verification, including the standardized 

numerical identifier; and (3) implement 

systems and processes to facilitate 

gathering the information necessary to 

produce the transaction information and 

statement for each transaction going 

back to the manufacturer if FDA or a 

trading partner requests an investigation 

in the event of a recall or a suspect or 

illegitimate product. 

In August 2023, the Agency published 

the ‘‘Enhanced Drug Distribution 

Security Requirements Under Section 

582(g)(1) of the Federal Food, Drug, and 

Cosmetic Act—Compliance Policies 

(Enhanced Drug Distribution Security 

Compliance Policies). (See https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

enhanced-drug-distribution-securityrequirements-under-section-582g1- 

federal-food-drug-and-cosmetic.) This 

guidance establishes a 1-year 

‘‘stabilization period’’ to accommodate 

the additional time trading partners 

need to implement, troubleshoot, and 

mature their secure, interoperable, 

electronic systems and processes while 

supporting the continued availability of 

products to patients. Specifically, the 

guidance describes that, until November 

27, 2024, FDA does not intend to take 

action to enforce requirements for the 

interoperable, electronic, package level 

product tracing under section 582(g)(1) 

of the FD&C Act that went into effect on 

November 27, 2023. In addition, FDA 

does not intend to take action to enforce 

section 582(g)(1)(B) of the FD&C Act 

with respect to drug product that is 

introduced in a transaction into 

commerce by the product’s 

manufacturer or repackager before 

November 27, 2024, and for subsequent 

transactions of such product through the 

product’s expiry. 

The Enhanced Drug Distribution 

Security Compliance Policies are 

intended to provide clarity and 

flexibility to trading partners to help 

ensure continued patient access to 

prescription drugs as the supply chain 

transitions to the secure, interoperable, 

electronic product tracing at the package 

level. The guidance does not provide, 

and should not be viewed as providing, 

a justification in delaying efforts by 

trading partners to implement the 

enhanced drug distribution security 

requirements under section 582(g)(1) of 

the FD&C Act. 

Because FDA expects trading partners 

to use this stabilization period to 

continue to build and validate secure, 

interoperable, electronic systems and 

processes, we are seeking information to 

confirm trading partners’ commitment 

to and progress on implementing 

DSCSA requirements for enhanced drug 

distribution security. 

II. Request for Information and 

Comments 

Interested persons are invited to 

provide detailed information and 

comments on the progress of their 

enhanced drug distribution security 

implementation. This information is 

intended to facilitate knowledge sharing 

among trading partners in order to help 

support successful implementation of 

secure, interoperable, electronic product 

tracing at the package level by 

November 27, 2024. FDA is particularly 

interested in information related to how 

your current and planned 

implementation ensures supply chain 


ddrumheller on DSK120RN23PROD with NOTICES1
80728 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 

readiness and a stronger and safer drug 

supply chain including the following: 

1. How are you using the stabilization 

period to: 

a. Troubleshoot and mature secure, 

electronic, interoperable systems and 

processes for enhanced drug 

distribution security with upstream 

trading partners? 

b. Troubleshoot and mature secure, 

electronic, interoperable systems and 

processes for enhanced drug 

distribution security with downstream 

trading partners? 

2. What are the most significant 

challenges you have overcome? What 

strategies did you employ to overcome 

those challenges? 

3. What aspects of your systems and 

processes have you successfully 

operationalized? 

4. What are the next steps in your 

strategy to ensure successful 

implementation of the enhanced drug 

distribution security requirements by 

November 27, 2024? 

Dated: November 15, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25609 Filed 11–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4718] 

Advancing the Development of 

Therapeutics Through Rare Disease 

Patient Community Engagement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Advancing the 

Development of Therapeutics Through 

Rare Disease Patient Community 

Engagement.’’ Convened by the DukeRobert J. Margolis, MD Center for Health 

Policy (Duke-Margolis) in collaboration 

with FDA and supported by a 

cooperative agreement between FDA 

and Duke-Margolis, the workshop will 

focus on how best to understand 

patients’ experiences living with a rare 

disease and how to incorporate those 

experiences, as well as patients’ 

priorities for treatment goals, 

throughout the drug development 

process. 

DATES: The public meeting will be held 

virtually on December 14, 2023, from 12 

p.m. to 5 p.m. Eastern Time. Either 

electronic or written comments on this 

public meeting must be submitted by 

February 12, 2024. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held virtually using the Zoom platform. 

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 February 12, 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– 

2023–N–4718 for ‘‘Advancing the 

Development of Therapeutics Through 

Rare Disease Patient Community 

Engagement.’’ 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: 

Stuti Ganatra, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Silver Spring, MD 

20993, 301–796–8112, PatientFocused@

fda.hhs.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1