Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 90015 

with the statute, for CY 2025. We also 

note that, even if notice and comment 

procedures were required for this 

notice, we would find good cause, for 

the previously stated reason, to waive 

the delay in effective date of the notice, 

as additional delay would be contrary to 

the public interest under section 

1871(e)(1)(B)(ii) of the Act. Publication 

of this notice is consistent with section 

1839 of the Act, and we believe that any 

potential delay in the effective date of 

the notice, if such delay were required 

at all, could cause unnecessary 

confusion for both the agency and 

Medicare beneficiaries. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on October 31, 

2024. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–26474 Filed 11–8–24; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–8087–N] 

RIN 0938–AV37 

Medicare Program; CY 2025 Part A 

Premiums for the Uninsured Aged and 

for Certain Disabled Individuals Who 

Have Exhausted Other Entitlement 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of 2025 Medicare Part A 

premium for uninsured enrollees. 

SUMMARY: This notice announces 

Medicare’s Hospital Insurance Program 

(Medicare Part A) premium for 

uninsured enrollees in calendar year 

(CY) 2025. This premium is paid by 

enrollees aged 65 and over who are not 

otherwise eligible for benefits under 

Medicare Part A (hereafter known as the 

‘‘uninsured aged’’) and by certain 

individuals with disabilities who have 

exhausted other entitlement. The 

monthly Medicare Part A premium for 

the 12 months beginning January 1, 

2025, for these individuals will be $518. 

The premium for certain other 

individuals as described in this notice 

will be $285. 

DATES: The premium announced in this 

notice is effective on January 1, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Yaminee Thaker, (410) 786–7921. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1818 of the Social Security 

Act (the Act) provides for voluntary 

enrollment in Medicare Part A, subject 

to payment of a monthly premium, of 

certain persons aged 65 and older who 

are uninsured under the Old-Age, 

Survivors, and Disability Insurance 

(OASDI) program or the Railroad 

Retirement Act and do not otherwise 

meet the requirements for entitlement to 

Medicare Part A. These ‘‘uninsured 

aged’’ individuals are uninsured under 

the OASDI program or the Railroad 

Retirement Act, because they do not 

have 40 quarters of coverage under Title 

II of the Act (or are/were not married to 

someone who did). (Persons insured 

under the OASDI program or the 

Railroad Retirement Act and certain 

others do not have to pay premiums for 

Medicare Part A.) 

Section 1818A of the Act provides for 

voluntary enrollment in Medicare Part 

A, subject to payment of a monthly 

premium for certain individuals with 

disabilities who have exhausted other 

entitlement. These are individuals who 

were entitled to coverage due to a 

disabling impairment under section 

226(b) of the Act, but who are no longer 

entitled to disability benefits and 

premium-free Medicare Part A coverage 

because they have gone back to work 

and their earnings exceed the statutorily 

defined ‘‘substantial gainful activity’’ 

amount (section 223(d)(4) of the Act). 

Section 1818A(d)(2) of the Act 

specifies that the provisions relating to 

premiums for the aged under section 

1818(d) through section 1818(f) of the 

Act will also apply to certain 

individuals with disabilities as 

described above. 

Section 1818(d)(1) of the Act requires 

us to estimate, on an average per capita 

basis, the amount to be paid from the 

Federal Hospital Insurance Trust Fund 

for services incurred in the upcoming 

calendar year (CY) (including the 

associated administrative costs) on 

behalf of individuals aged 65 and over 

who will be entitled to benefits under 

Medicare Part A. We must then 

determine the monthly actuarial rate for 

the following year (the per capita 

amount estimated above divided by 12) 

and publish the dollar amount for the 

monthly premium in the succeeding CY. 

If the premium is not a multiple of $1, 

the premium is rounded to the nearest 

multiple of $1 (or, if it is a multiple of 

50 cents but not of $1, it is rounded to 

the next highest $1). 

Section 13508 of the Omnibus Budget 

Reconciliation Act of 1993 (Pub. L. 103– 

66) amended section 1818(d) of the Act 

to provide for a reduction in the 

premium amount for certain voluntary 

enrollees (sections 1818 and 1818A of 

the Act). The reduction applies to an 

individual who is eligible to buy into 

the Medicare Part A program and who, 

as of the last day of the previous month: 

• Had at least 30 quarters of coverage 

under Title II of the Act; 

• Was married, and had been married 

for the previous 1-year period, to a 

person who had at least 30 quarters of 

coverage; 

• Had been married to a person for at 

least 1 year at the time of the person’s 

death if, at the time of death, the person 

had at least 30 quarters of coverage; or 

• Is divorced from a person and had 

been married to the person for at least 

10 years at the time of the divorce if, at 

the time of the divorce, the person had 

at least 30 quarters of coverage. 

Section 1818(d)(4)(A) of the Act 

specifies that the premium that these 

individuals will pay for CY 2025 will be 

equal to the premium for uninsured 

aged enrollees reduced by 45 percent. 

Section 1818(g) of the Act requires the 

Secretary of the Department of Health 

and Human Services (the Secretary), at 

the request of a state, to enter into a 

Medicare Part A buy-in agreement with 

a state to pay Medicare Part A premiums 

for Qualified Medicare Beneficiaries 

(QMBs). Under the QMB program, state 

Medicaid agencies must pay the 

Medicare Part A premium for those not 

eligible for premium-free Medicare Part 

A if those individuals meet all of the 

eligibility requirements for the QMB 

program under the state’s Medicaid state 

plan. (Entering into a Medicare Part A 

buy-in agreement would permit a state 

to avoid any Medicare Part A late 

enrollment penalties that the individual 

may owe and would allow states to 

enroll persons in Medicare Part A at any 

time of the year, without regard to 

Medicare enrollment periods.) Other 

individuals may be eligible for the 

Qualified Disabled Working Individuals 

program, through which state Medicaid 

programs provide coverage of Medicare 

Part A premiums for individuals eligible 

to enroll in Medicare Part A by virtue 

of section 1818A of the Act who meet 

certain financial eligibility criteria. 

II. Monthly Premium Amount for CY 

2025 

The monthly premium for the 

uninsured aged and certain individuals 

with disabilities who have exhausted 

other entitlement for the 12 months 

beginning January 1, 2025, is $518. The 

monthly premium for the individuals 

eligible under section 1818(d)(4)(B) of 

the Act, and therefore, subject to the 45 


ddrumheller on DSK120RN23PROD with NOTICES1
90016 Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 

percent reduction in the monthly 

premium, is $285. 

III. Monthly Premium Rate Calculation 

As discussed in section I of this 

notice, the monthly Medicare Part A 

premium is equal to the estimated 

monthly actuarial rate for CY 2025 

rounded to the nearest multiple of $1 

and equals one-twelfth of the average 

per capita amount, which is determined 

by projecting the number of Medicare 

Part A enrollees aged 65 years and over, 

as well as the benefits and 

administrative costs that will be 

incurred on their behalf. 

The steps involved in projecting these 

future costs to the Federal Hospital 

Insurance Trust Fund are: 

• Establishing the present cost of 

services furnished to beneficiaries, by 

type of service, to serve as a projection 

base; 

• Projecting increases in payment 

amounts for each of the service types; 

and 

• Projecting increases in 

administrative costs. 

We base our projections for CY 2025 

on—(1) current historical data; and (2) 

projection assumptions derived from 

current law and the President’s Fiscal 

Year 2025 Budget. 

For CY 2025, we estimate that 

61,199,491 people aged 65 years and 

over will be entitled to (enrolled in) 

benefits (without premium payment) 

and that they will incur about $380.149 

billion in benefits and related 

administrative costs. Thus, the 

estimated monthly average per capita 

amount is $517.64 and the monthly 

premium is $518. Subsequently, the full 

monthly premium reduced by 45 

percent is $285. 

IV. Costs to Beneficiaries 

The CY 2025 monthly premium of 

$518 is approximately 2.6 percent 

higher than the CY 2024 premium of 

$505. We estimate that approximately 

756,000 enrollees will voluntarily enroll 

in Medicare Part A by paying the full 

premium. We estimate that over 90 

percent of these individuals will have 

their Medicare Part A premium paid for 

by states, since they are enrolled in the 

QMB program. Furthermore, the CY 

2025 reduced monthly premium of $285 

is approximately 2.5 percent higher than 

the CY 2024 premium of $278. We 

estimate that an additional 97,000 

enrollees will pay the reduced 

premium. Therefore, we estimate that 

the total aggregate cost to enrollees 

paying these premiums in CY 2025, 

compared to the amount that they paid 

in CY 2024, will be about $126 million. 

V. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment 

prior to a rule taking effect in 

accordance with section 1871 of the Act 

and section 553(b) of the Administrative 

Procedure Act (APA). Section 1871(a)(2) 

of the Act provides that no rule, 

requirement, or other statement of 

policy (other than a national coverage 

determination) that establishes or 

changes a substantive legal standard 

governing the scope of benefits, the 

payment for services, or the eligibility of 

individuals, entities, or organizations to 

furnish or receive services or benefits 

under Medicare shall take effect unless 

it is promulgated through notice and 

comment rulemaking. Unless there is a 

statutory exception, section 1871(b)(1) 

of the Act generally requires the 

Secretary to provide for notice of a 

proposed rule in the Federal Register 

and provide a period of not less than 60 

days for public comment before 

establishing or changing a substantive 

legal standard regarding the matters 

enumerated by the statute. Similarly, 

under 5 U.S.C. 553(b) of the APA, the 

agency is required to publish a notice of 

proposed rulemaking in the Federal 

Register before a substantive rule takes 

effect. Section 553(d) of the APA and 

section 1871(e)(1)(B)(i) of the Act 

usually require a 30-day delay in 

effective date after issuance or 

publication of a rule, subject to 

exceptions. Sections 553(b)(B) and 

553(d)(3) of the APA provide for 

exceptions from the advance notice and 

comment requirement and the delay in 

effective date requirements. Sections 

1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the 

Act also provide exceptions from the 

notice and 60-day comment period and 

the 30-day delay in effective date. 

Section 553(b)(B) of the APA and 

section 1871(b)(2)(C) of the Act 

expressly authorize an agency to 

dispense with notice and comment 

rulemaking for good cause if the agency 

makes a finding that notice and 

comment procedures are impracticable, 

unnecessary, or contrary to the public 

interest. 

The annual Medicare Part A premium 

announcement set forth in this notice 

does not establish or change a 

substantive legal standard regarding the 

matters enumerated by the statute or 

constitute a substantive rule which 

would be subject to the notice 

requirements in section 553(b) of the 

APA. However, to the extent that an 

opportunity for public notice and 

comment could be construed as 

required for this notice, we find good 

cause to waive this requirement. Section 

1818(d) of the Act requires the Secretary 

during September of each year to 

determine and publish the amount to be 

paid, on an average per capita basis, 

from the Federal Hospital Insurance 

Trust Fund for services incurred in the 

impending CY (including the associated 

administrative costs) on behalf of 

individuals aged 65 and over who will 

be entitled to benefits under Medicare 

Part A. Further, the statute requires that 

the agency determine the applicable 

premium amount for each CY in 

accordance with the statutory formula, 

and we are simply notifying the public 

of the changes to the Medicare Part A 

premiums for CY 2025. We have 

calculated the Medicare Part A 

premiums as directed by the statute; the 

statute establishes both when the 

premium amounts must be published 

and the information that the Secretary 

must factor into the premium amounts, 

so we do not have any discretion in that 

regard. We find notice and comment 

procedures to be unnecessary for this 

notice and we find good cause to waive 

such procedures under section 553(b)(B) 

of the APA and section 1871(b)(2)(C) of 

the Act, if such procedures may be 

construed to be required at all. Through 

this notice, we are simply notifying the 

public of the updates to the Medicare 

Part A premiums, in accordance with 

the statute, for CY 2025. As such, we 

also note that even if notice and 

comment procedures were required for 

this notice, for the reasons stated above, 

we would find good cause to waive the 

delay in effective date of the notice, as 

additional delay would be contrary to 

the public interest under section 

1871(e)(1)(B)(ii) of the Act. Publication 

of this notice is consistent with section 

1818(d) of the Act, and we believe that 

any potential delay in the effective date 

of the notice, if such delay were 

required at all, could cause unnecessary 

confusion both for the agency and 

Medicare beneficiaries. 

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.). 

VII. Regulatory Impact Analysis 

Although this notice does not 

constitute a significant regulatory action 

(defined below), we nevertheless 

prepared this Regulatory Impact 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 90017 

Analysis (RIA) section in the interest of 

ensuring that the impacts of this notice 

are fully understood. 

A. Statement of Need 

This notice announces the CY 2025 

Medicare Part A premiums for the 

uninsured aged and for certain disabled 

individuals who have exhausted other 

entitlement, as required by sections 

1818 and 1818A of the Act. It also 

responds to section 1818(d) of the Act, 

which requires the Secretary to provide 

for publication of these amounts in the 

Federal Register during the September 

that precedes the start of each CY. As 

this statutory provision prescribes a 

detailed methodology for calculating 

these amounts, we do not have the 

discretion to adopt an alternative 

approach on these issues. 

B. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), Executive Order 14094 titled 

‘‘Modernizing Regulatory Review’’ 

(April 6, 2023), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, section 202 of 

the Unfunded Mandates Reform Act of 

1995 (March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999), and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). The Executive Order 14094 

titled ‘‘Modernizing Regulatory Review’’ 

amends section 3(f)(1) of Executive 

Order 12866 (Regulatory Planning and 

Review). The amended section 3(f) of 

Executive Order 12866 defines a 

‘‘significant regulatory action’’ as an 

action that is likely to result in a rule 

that may: (1) have an annual effect on 

the economy of $200 million or more, 

(adjusted every 3 years by the 

Administrator of OMB’s 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; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impacts of 

entitlement grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise legal or 

policy issues for which centralized 

review would meaningfully further the 

President’s priorities or the principles 

set forth in this Executive order, as 

specifically authorized in a timely 

manner by OIRA in each case. 

A regulatory impact analysis (RIA) 

must be prepared for rules with 

significant regulatory action(s) as per 

section 3(f)(1) of Executive Order 12866 

($200 million or more in any one year). 

Based on our estimates, OIRA has 

determined that this notice is not 

significant per section 3(f)(1) of E.O. 

12866 as measured by the $200 million 

or more impact in any one year. 

In accordance with the Congressional 

Review Act, OIRA has determined that 

this notice meets the criteria set forth in 

5 U.S.C. 804(2). Accordingly, we have 

prepared an RIA that to the best of our 

ability presents the costs and benefits of 

this notice. 

As stated in section IV. of this notice, 

we estimate that the overall effect of the 

changes in the Medicare Part A 

premium will be a cost to voluntary 

enrollees (sections 1818 and 1818A of 

the Act) of about $126 million. 

C. Accounting Statement and Table 

As required by OMB Circular A–4 

(available at https://

www.whitehouse.gov/wp-content/ 

uploads/legacy_drupal_files/omb/ 

circulars/A4/a-4.pdf), in the table 1, we 

have prepared an accounting statement 

showing the total aggregate cost to 

enrollees paying premiums in CY 2025, 

compared to the amount that they paid 

in CY 2024. This amount is 

approximately $126 million. As stated 

in section IV. of this notice, the CY 2025 

premium of $518 is approximately 2.6 

percent higher than the CY 2024 

premium of $505. We estimate that 

approximately 756,000 enrollees will 

voluntarily enroll in Medicare Part A by 

paying the full premium. We estimate 

that over 90 percent of these individuals 

will have their Medicare Part A 

premium paid for by states, since they 

are enrolled in the QMB program. 

Furthermore, the CY 2025 reduced 

premium of $285 is approximately 2.5 

percent higher than the CY 2024 

premium of $278. 

TABLE 1—ESTIMATED TRANSFERS FOR

CY 2025 MEDICARE PART A PREMIUMS

Category Transfers Period 

covered 

Annualized 

Monetized 

Transfers.

$126 million ..... 2025 

From Whom to 

Whom.

Beneficiaries to 

Federal Government.

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

D. Regulatory Flexibility Act 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities, if a rule has a significant impact 

on a substantial number of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

being nonprofit organizations or by 

meeting the Small Business 

Administration’s (SBA) definition of a 

small business (having revenues of less 

than $9.0 million to $47 million in any 

1 year). Individuals and states are not 

included in the definition of a small 

entity. This annual notice announces 

the Medicare Part A premiums for CY 

2025 and will have an impact on certain 

Medicare beneficiaries, but not on small 

entities as defined by the SBA. As a 

result, we are not preparing an analysis 

for the RFA because the Secretary has 

certified that this notice will not have a 

significant economic impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the Act 

requires us to prepare an RIA if a rule 

may have a significant impact on the 

operations of a substantial number of 

small rural hospitals. This analysis must 

conform to the provisions of section 604 

of the RFA. For purposes of section 

1102(b) of the Act, we define a small 

rural hospital as a hospital that is 

located outside of a metropolitan 

statistical area and has fewer than 100 

beds. This annual notice announces the 

Medicare Part A premiums for CY 2025 

and will have an impact on certain 

Medicare beneficiaries. As a result, we 

are not preparing an analysis for section 

1102(b) of the Act, because the Secretary 

has certified that this notice will not 

have a significant impact on the 

operations of a substantial number of 

small rural hospitals. 

E. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 


ddrumheller on DSK120RN23PROD with NOTICES1
90018 Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2024, that threshold is approximately 

$183 million. This notice would not 

impose a mandate that will result in the 

expenditure by state, local, and Tribal 

Governments, in the aggregate, or by the 

private sector, of more than $183 

million in any 1 year. 

F. Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has federalism implications. 

This notice will not have a substantial 

direct effect on state or local 

governments, preempt state law, or 

otherwise have federalism implications. 

G. Congressional Review 

This notice is subject to the 

Congressional Review Act and has been 

transmitted to the Congress and the 

Government Accountability Office’s 

Comptroller General for review. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on October 31, 

2024. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–26473 Filed 11–8–24; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4815] 

Patient-Focused Drug Development: 

Workshop To Discuss Methodologic 

and Other Challenges Related to 

Patient Experience Data; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following virtual 

public workshop entitled ‘‘PatientFocused Drug Development: Workshop 

to Discuss Methodologic and Other 

Challenges Related to Patient 

Experience Data.’’ The purpose of the 

public workshop is to discuss 

methodological challenges related to 

patient experience data, and other areas 

of greatest interest or concern to public 

stakeholders. 

DATES: The public workshop will be 

held virtually on December 13, 2024, 

from 10 a.m. to 5 p.m. Eastern Time. 

Either electronic or written comments 

on this public meeting must be 

submitted by February 11, 2025. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop 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 11, 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 

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–4815 for ‘‘Patient-Focused Drug 

Development: Workshop to Discuss 

Methodologic and Other Challenges 

Related to Patient Experience Data.’’ 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1