67760 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

1. Provider telephone script and recruitment information collection ............... 204 1 0.33 67 

2. Provider telephone script and recruitment information collection including 

observations ................................................................................................. 150 1 .42 63 

3. HBCC–NSAC Toolkit provider questionnaire .............................................. 150 1 .75 113 

4. Family survey .............................................................................................. 166 1 0.25 42 

Estimated Total Annual Burden 

Hours: 285. 

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. 9858. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–21649 Filed 9–29–23; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Application Requirements for 

the Low Income Home Energy 

Assistance Program (LIHEAP) Model 

Plan Application (Office of 

Management and Budget #0970–0075) 

AGENCY: Office of Community Services, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Community 

Services (OCS), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is requesting to extend 

the currently approved Low Income 

Home Energy Assistance Program 

(LIHEAP) Model Plan Application 

(OMB #0970–0075, expiration 12/31/ 

2023) through August 31, 2024, and 

then making significant revisions to the 

FY 2025 application to be effective 

September 1, 2024. This notice outlines 

the proposed revisions for FY 2025. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing infocollection@

acf.hhs.gov. Identify all requests by the 

title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: States, including the 

District of Columbia, tribes, tribal 

organizations, and U.S. territories 

applying for LIHEAP block grant funds 

must, prior to receiving federal funds, 

submit an annual application (Model 

Plan) that meets the LIHEAP statutory 

and regulatory requirements. In addition 

to the Model Plan, grant recipients are 

also required to complete the Mandatory 

Grant Application, SF–424—Mandatory, 

which is included as the first section of 

the Model Plan. 

The LIHEAP Model Plan is an 

electronic form and is submitted to 

ACF/OCS through the On-Line Data 

Collection (OLDC) system within 

GrantSolutions, which is currently 

being used by all LIHEAP grant 

recipients to submit other required 

LIHEAP reporting forms. To reduce the 

reporting burden, all data entries from 

each grant recipient’s prior year’s 

submission of the Model Plan in OLDC 

are saved and re-populated into the 

form for the following fiscal year’s 

application. 

OCS is requesting the current LIHEAP 

Model Plan form to be extended through 

August 31, 2024. The currently 

approved form and justification package 

can be reviewed here: https://

www.reginfo.gov/public/do/

PRAViewICR?ref_nbr=202009-0970- 

011). 

OCS proposes the following changes 

to the LIHEAP Model Plan form 

beginning with FY 2025 reporting 

effective September 1, 2024: 

SF–424 Model Plan 

• 4a: Change from ‘‘Federal Entity 

Identifier’’ to ‘‘Unique Entity Identifier 

(UEI).’’ 

• 7b and c: Remove UEI is requested 

in 4a. 

• 7f: Add after current language 

‘‘(This person will be listed on Notice of 

Funding Awards and on the U.S. 

Department of Health and Human 

Services’ LIHEAP contact list web 

page)’’ 

Æ Remove Prefix, Suffix, Middle 

Name and Organizational Affiliation. 

• 8a: Remove the ‘‘a’’ after 8 ‘‘Type of 

Applicant’’ 

• Add: 8a Is the applicant a Tribal 

Consortium? 

Æ Add: 8b If yes, please attach at least 

one the following documentation: 

Æ (1) Current State-Tribe Agreement 

between their state and the Consortium, 

signed by the State Chief Executive 

Officer (such as a Governor or the 

delegate) and the Consortium President; 

Æ (2) Consortium letter listing the 

Tribes and signed by the elected Tribal 

Chief or President of each Tribe in the 

Consortium and signed by the 

Consortium President; 

Æ (3) A current resolution letter from 

each tribe in the Consortium, signed by 

the elected Tribal Chief or President of 

that Tribe. Each resolution letter needs 

to state that the Consortium has the 

Tribes’ permission to apply for, and 

administer, LIHEAP on their behalf; 

needs to designate a time period for the 

permission or until rescinded or 

revoked. 

• 8b: Remove, not utilized. 

• 9: Remove ‘‘Name of Federal 

Agency’’—not used. 

• 13: Change to ‘‘CONGRESSIONAL 

DISTRICTS OF APPLICANT’’ 

Æ Eliminate 13a and b.—Already 

answered in #7; and Eliminate ‘‘Attach 


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an additional list of Program/Project 

Congressional Districts, if needed.’’ 

• 15 a and b: Remove. 

• 17: At the end of the question, 

change ‘‘explanation’’ to ‘‘If Yes, 

explain.’’ 

Section 1—Program Components 

Introduction: Remove reference to 

grant recipient filing abbreviated plan. 

LIHEAP does not use abbreviated plans 

any longer. 

• 1.1 Crisis assistance: Create one 

question for ‘‘Summer crisis assistance,’’ 

one question for ‘‘Winter crisis 

assistance,’’ and one for ‘‘Year-round 

assistance.’’ We are receiving increase 

data request to understand the type of 

crisis programs provided. 

• 1.2: 

Æ Add a data entry column and 

provide the breakdown of funding from 

the previous year’s plan. This 

information is useful for the data 

dashboard. 

Æ Add language for ‘‘Tribal grant 

recipients: direct-grant tribes, tribal 

organizations, or territories with 

allotments of $20,000 or less may use 

for planning and administration up to 

20% of the funds payable. Grant 

recipients that are direct-grant tribes, 

tribal organizations, or territories with 

allotments over $20,000 may use for 

planning and administration purposes 

up to 20% of the first $20,000 (or 

$4,000) plus 10% of the funds payable 

that exceeds $20,000. Any 

administrative costs in excess of these 

limits must be paid from non-Federal 

sources.’’ 

Æ Change ‘‘Crisis Assistance’’ to 

‘‘Summer crisis assistance,’’ one 

question for ‘‘Winter crisis assistance,’’ 

and one for ‘‘Year-round assistance.’’ 

• 1.4: 

Æ Remove Other and entire column. 

All allowable options are listed, other is 

not applicable. 

Æ Insert ‘‘at least’’ before the word 

‘‘one’’ in two places in this question. 

The edited question would be ‘‘Do you 

consider households categorically 

eligible if at least one household 

member receives at least one of the 

following categories of benefits in the 

left column below?’’ 

• 1.4a—Add a text box ‘‘Provide your 

definition of categorical eligibility. 

Please explain how households are 

categorically eligible (i.e., do all 

household members need to receive the 

benefits or just one member, is there a 

data exchange in place?) and how 

categorical eligibility streamlines the 

LIHEAP application process.’’ This will 

ensure grant recipients understand 

categorical eligibility and answer the 

question appropriately. 

• If 1.4 is answered no, do not allow 

the table to be completed. Caused data 

inconsistencies in the data dashboard 

and requires manual review. 

• 1.7: 

Æ Hyperlink the word ‘‘nominal’’ to a 

description of the word: Nominal 

benefits are LIHEAP payments over $20 

made to SNAP households with an 

energy burden that allow the household 

to claim the SNAP ‘‘heating/cooling 

standard utility allowance’’ (SUA). 

• 1.8—Add ‘‘Other—Describe.’’ Grant 

recipients indicated there are exceptions 

and this box will allow those exceptions 

to be described and understood more 

clearly. 

• 1.9—Remove SNAP and WIC as 

they cannot be counted as income. 

• Add: 1.10 Do you have an online 

application process (Yes/No)? 

• Add: 1.10a If yes, describe the 

type of online application (Select all 

boxes that apply). 

Æ A PDF version of the application is 

available online and can be 

downloaded, filled out, and mailed in 

for processing. 

Æ A state-wide online application that 

allows a customer to complete data 

entry and submit an application 

electronically for processing. 

Æ One or more locally available 

online applications that allows a 

customer to complete data entry and 

submit an application electronically for 

processing. 

Æ Online application that is also 

mobile friendly. 

Æ Other, please describe. 

Æ If any of the above boxes are 

checked, please include a link here: 

• Add: 1.10b Can all program 

components be applied for online (Yes/ 

No)? If no, explain which components 

can and cannot be applied for online. 

• 1.11 Do you have a process for 

conducting and completing applications 

by phone (Yes/No)? 

• 1.12 Do you or any of your 

subrecipients require in-person 

appointments in order to apply (Yes/ 

No)? If yes, please provide more 

information. 

• 1.13 How can applicants submit 

documentation for verification? Select 

all that apply (in-person, mail, email, 

portal application, other-describe). 

Section 2—Heating Assistance 

• 2.2—Correct the spelling of 

‘‘assistance’’ 

• 2.3—Change ‘‘Elderly’’ to ‘‘Older 

Adults’’ (60 years or older) 

• 2.3—Change ‘‘Disabled’’ to 

‘‘Individuals with a disability’’ 

• 2.4—Add space between ‘‘to’’ and 

‘‘vulnerable’’ 

• 2.6—Add the following sentence: 

‘‘Please note: the maximum and 

minimum benefits must be shown in the 

payment matrix.’’ 

Section 3—Cooling Assistance 

• 3.3—Change ‘‘Elderly’’ to ‘‘Older 

Adults’’ 

• 3.3—Change ‘‘Disabled’’ to 

‘‘Individuals with a disability’’ 

• 3.4—Add space between ‘‘to’’ and 

‘‘vulnerable’’ 

• 3.6—Add the following sentence: 

‘‘Please note: the maximum and 

minimum benefits must be shown in the 

payment matrix.’’ 

Section 4—Crisis Assistance 

• 4.2—Add to narrative, ‘‘If you 

administer multiple crisis assistance 

programs (winter, summer, and/or yearround), include all program 

definitions.’’ 

• 4.6–4.7 and 4.10–4.13—Modify so 

that it is no longer ‘‘yes or no’’ but 

mirrors question 4.15 so they can select 

which program the response is 

applicable. If the component is not 

selected under 1.2, the boxes will be 

grayed out so they cannot select that 

option. Modify the instructions for the 

section to be ‘‘Check appropriate boxes 

below to indicate type(s) of assistance 

provided’’ 

• 4.6—Remove all CAPS from Crisis 

Assistance 

• 4.7—Change ‘‘Elderly’’ to ‘‘Older 

Adults’’ 

• 4.7—Change ‘‘Disabled’’ to 

‘‘Individuals with a disability’’ 

• 4.8—Modify ‘‘Fast Track’’ to 

‘‘Benefit Fast Track, no separate amount 

of crisis funds is issued. Rather benefits 

are issued to crisis customers within 

crisis response time frames’’ 

• 4.9—Add a box next to the 

question, ‘‘Amount to resolve crisis, up 

to a maximum amount’’ 

• 4.11—Change ‘‘Physically 

Disabled’’ to ‘‘Individuals with a 

disability’’ 

• 4.18—Add question that says, ‘‘Do 

you intend to utilize LIHEAP crisis 

funds to address disaster related crisis 

situations? ‘‘Yes’’ or ‘‘No’’ If yes, 

describe.’’ Add hover over box that 

states ‘‘OCS’ block grant funding has 

built in flexibility to support grant 

recipients in disaster response. Please 

visit https://ocs-emergency-assistancehhs-acf.hub.arcgis.com/ for additional 

information’’ (508 compliant hyperlink). 

Section 5—Weatherization 

• 5.3—Modify to ‘‘If yes, name the 

agency and attach a copy of the Internal 

Agreement or Contract.’’ 

• 5.8—Change ‘‘Elderly’’ to ‘‘Older 

Adults’’ 

• 5.8—Change ‘‘Disabled’’ to 

‘‘Individuals with a Disability’’ 


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67762 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 

• 5.9—Add a 5.9a replace with 

current 5.10 ‘‘If yes, what is the 

maximum’’ 

• 5.10—Change to ‘‘Do you use an 

Average Cost per Unit (ACPU).’’ 

Æ 5.10a If so, what is the ACPU 

amount? 

• 5.11—This section needs two boxes 

for roof top solar and community solar 

projects. 

Section 6—Outreach 

• 6.1—This section needs to include 

other outreach including web posting, 

email, texting, events, and social media. 

Section 7—Coordination 

• 7.1—This section needs to include 

data entry field next to the first two 

boxes. 

• Joint application for multiple 

programs (indicate programs included) 

• Intake referrals to/from other 

programs (indicate programs) 

Section 8—Agency Designation 

• 8.1— 

Æ Add ‘‘Economic Development 

Agency’’ 

Æ Change ‘‘Welfare’’ to ‘‘State 

Department of Welfare (administers 

TANF, SNAP, and/or Medicaid)’’ 

Æ Eliminate space between ‘‘Energy’’ 

and ‘‘/’’ and ‘‘Environment Agency’’ 

• New Attachment: Include current 

list of subrecipient name, main office 

address (do not list P.O. Box), phone 

number, county(s) served, Congressional 

District, and UEI number. Used for Near 

hotline and OCS Service Provider Tool 

and clearinghouse. 

• Add 8.10: ‘‘If an agency is no longer 

providing LIHEAP, are you aware of 

prior-year LIHEAP funds being 

mismanaged or misspent? Yes or No’’ 

• 8.10a ‘‘If yes, please explain.’’ 

• 8.10b ‘‘Were other federal 

programs impacted such as CSBG, 

SSBG, Head Start, TANF, and Dept. of 

Energy Weatherization funding, etc.? 

Yes or No’’ 

• 8.10c ‘‘If yes, please explain.’’ 

Æ Questions added due to previous 

situations and questions needing a 

response to these specific items. 

Section 9—Energy Suppliers 

• Add option at the end of the section 

to attach a copy of the vendor 

agreement. 

Section 10—Program, Fiscal Monitoring 

and Audit 

• 10.1—Revise the question as, ‘‘How 

do you ensure proper fiscal accounting 

and tracking of funds?’’ Add the 

following instructional sentence: ‘‘Be 

specific about tracking of grant award, 

tracking of expenditures, tracking 

vendor (benefit) refunds, fiscal reporting 

process, and fiscal software system 

being used.’’ Clarification for grant 

recipients. 

• 10.1a—New Question: ‘‘Provide 

your definitions of the following: 

Æ Obligation (insert explanation box) 

Æ Expenditures (insert explanation 

box) 

Æ Expenditure timeframe (insert 

explanation box) 

Æ Administrative costs (insert 

explanation box)’’ 

• 10.2a—Add question: ‘‘If yes, 

describe your auditor selection 

process.’’ 

• 10.3—Change wording to ‘‘Describe 

any audit findings of the grant recipient 

(i.e., State/Tribe/Territory) rising to the 

level of material weakness or reportable 

condition cited in the single audits, 

inspector general reviews, or other 

government agency reviews from the 

most recently audited fiscal year.’’ 

• 10.5—Change question to ‘‘Describe 

your monitoring process for compliance 

at each level below.’’ 

Æ Change ‘‘Grant recipient 

employees’’ check box to state: 

• Grant recipients have a policy in 

place for appropriate separation of 

duties and internal controls 

• Other, describe 

• 10.7—Rewrite the question as 

‘‘Describe how you select local agencies 

for monitoring reviews. Attach a risk 

assessment if subrecipients are 

utilized.’’ 

• 10.8—Add boxes ‘‘Annually,’’ ‘‘Biannually,’’ ‘‘Tri-annually,’’ and ‘‘Other.’’ 

Please attach a monitoring schedule if 

one has been developed. 

• 10.9 and 10.10—Remove. 

• 10.11—Revise the question to, 

‘‘How many local agencies are currently 

on corrective action plans?’’ 

• 10.12—Remove. 

Section 11—Timely and Meaningful 

Public Participation 

• 11.1—Add explanation that Tribes 

do not need to hold a public hearing but 

must ensure participation through other 

means. 

• 11.2—Remove. Removing because 

question is duplicative of 11.6. 

• 11.3—Insert an option to add rows 

for additional dates and locations that 

they held public hearings on the 

proposed use and distribution of their 

LIHEAP funds. 

• 11.6—Revise the question as 

follows: ‘‘What changes did you make to 

your LIHEAP plan as a result of public 

participation and solicitation of input?’’ 

Section 12—Fair Hearing 

• 12.4—Change question: ‘‘Describe 

your fair hearing procedures for 

households whose applications are 

denied and/or not acted upon in a 

timely manner.’’ 

• 12.5—Remove. 

• 12.6—Remove. 

Section 13—Reduction of Home Energy 

Needs 

• 13.3—Add the following 

instructional sentence: ‘‘Impact can be 

measured in many different ways by 

using: logic model, data tracking system, 

process evaluation, impact evaluation, 

number of households served vs 

applied, and performance management, 

etc.’’ 

• 13.4—Add a space between ‘‘of’’ 

and ‘‘direct’’ 

• 13.5—Remove. 

Section 14—Leveraging Incentive 

Program 

• 14.3—Add a space between ‘‘of’’ 

and ‘‘45’’ 

Section 15—Training 

• 15.1a–c—Change question to be 

consistent with each entity type (grant 

recipient, local agency, vendor) 

Æ Formal training provided virtually, 

on-site, and/or formal training 

conference 

• Annually 

• Biannually 

• As needed 

• Other, describe 

Section 17—Program Integrity 

• 17.1b—Add ‘‘Posted in local 

administering agencies offices.’’ 

• 17.4—Change ‘‘aliens’’ to ‘‘qualified 

non-citizens’’ in intro text. The second 

option in the question is phrased as 

‘‘legal residence’’ but it needs to be 

changed to ‘‘U.S. Citizen or Qualified 

Non-Citizen.’’ The second box option 

should read ‘‘Client’s submission of 

certain Social Security Administration 

cards is accepted as proof of U.S. 

Citizen or Qualified Non-Citizen.’’ 

• 17.4—Rewrite the question as 

‘‘What are your procedures for ensuring 

LIHEAP recipients are U.S. citizens or 

qualified non-citizens who are eligible 

to receive LIHEAP benefits?’’ 

• 17.6—Should also include how 

electronic files are protected in a secure 

location. 

Section 19—Certification Regarding 

Drug-Free Workplace Requirements 

• 19.1—Place of Performance: Add 

instructional sentence that this must be 

physical address. No PO Boxes allowed. 

Section 21—New Change Assurances to 

Section 21 

• 21.1—Add the following 

acknowledgment statement and a check 


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box: ‘‘By checking this box, the 

prospective primary participant is 

agreeing to the Assurances set out 

above.’’ 

Section 22—Attachments 

• Add optional attachment section for 

the following items: Policy Manual; 

Subrecipient Contract; Model Plan 

Participation Notes for Tribes. 

Respondents: States, the District of 

Columbia, U.S. territories, and tribal 

governments. 

Annual Burden Estimates 

The estimated time per response for 

the FY 2025 Model Plan has been 

increased based on the revisions. The 

estimated time per response for the FY 

2026 Model Plan will reduce back after 

revisions are in place and respondents 

can duplicate response in OLDC. 

Instrument 

Total annual 

number of 

respondents 

Total annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

for each form 

LIHEAP Detailed Model Plan—FY24 .............................................................. 210 1 .5 105 

LIHEAP Detailed Model Plan—FY25 .............................................................. 206 1 1 206 

LIHEAP Detailed Model Plan FY26 ................................................................. 206 1 .5 103 

Estimated Total Burden Hours: ................................................................ ........................ ........................ ........................ 414 

Average Annual Burden Hours: ............................................................... ........................ ........................ ........................ 138 

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. 8621. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–21663 Filed 9–29–23; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3976] 

Support for Clinical Trials Advancing 

Rare Disease Therapeutics Pilot 

Program; Program Announcement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research’s (CBER) Office of Therapeutic 

Products (OTP) and Center for Drug 

Evaluation and Research’s (CDER) 

Office of New Drugs are announcing the 

opportunity for a limited number of 

development programs to participate in 

the Support for clinical Trials 

Advancing Rare disease Therapeutics 

(START) Pilot Program, with the goal of 

further accelerating the pace of 

development of certain CBER- and 

CDER-regulated products (novel drug 

and biological products) that are 

intended to treat a rare disease. Because 

each Center has identified specific 

needs concerning regulated products for 

rare diseases, the eligibility criteria for 

the pilot differ between CBER and 

CDER. This pilot would augment the 

currently available formal meetings 

between FDA and sponsors by 

addressing issues related to the 

development of individual products 

through more rapid, ad-hoc 

communication mechanisms. Sponsors, 

if selected for the pilot, would receive 

more frequent advice related to such 

specific issues through additional 

interactions to facilitate novel drug and 

biological product program 

development and generate high quality 

and reliable data intended to support a 

Biologics License Application (BLA) or 

New Drug Application (NDA). This 

notice outlines the eligibility criteria, 

what to submit in a request to 

participate in the pilot, selection 

criteria, process, and FDA-Sponsor 

interactions expected to occur for 

programs participating in the pilot. 

DATES: From January 2, 2024, to March 

1, 2024, FDA will accept requests to 

participate in the START Pilot Program 

and select no more than three 

participants from each Center (CBER 

and CDER). See the ‘‘Participation’’ 

section for eligibility criteria, 

instructions on how to submit a request 

to participate, and information 

regarding the selection process. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Harvan, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7268, 

Silver Spring, MD 20993–0002, 240– 

402–7911; or Quyen Tran, Center for 

Drugs Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6301, 

Silver Spring, MD 20993–0002, 301– 

796–2771. 

For general questions about the 

START Pilot Program for CBER: 

Industry.biologics@fda.hhs.gov. For 

general questions about the START Pilot 

Program for CDER: 

CDER.STARTProgram@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The purpose of the START Pilot 

Program is to further accelerate the pace 

of development of novel drug and 

biological products that are intended to 

address an unmet medical need as a 

treatment for a rare disease. The pilot is 

designed to be milestone-driven (i.e., to 

facilitate the progression of a 

development program to pivotal clinical 

study stage or the pre-BLA or pre-NDA 

meeting stage) where product 

development programs selected would 

benefit from enhanced communications 

with FDA. Participation in the pilot will 

be considered concluded when the 

development program has reached a 

significant regulatory milestone such as 

initiation of the pivotal clinical study 

stage or the pre-BLA or pre-NDA 

meeting stage as agreed upon with the 

sponsor. Pilot participants will be 

selected based on demonstrated 

development program readiness. The 

START Pilot Program is intended to 

provide a mechanism for addressing 

clinical development issues that 

otherwise would delay or prevent a 

promising novel drug or biological 

product from progressing to the pivotal 


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