Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1101 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

FDA Traineeship Program ................................................... 1,000 1 1,000 1 1,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00220 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4804] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Expedited 

Programs for Serious Conditions— 

Drugs and Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection pertaining to ‘‘Expedited 

Programs for Serious Conditions—Drugs 

and Biologics.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 11, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 11, 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–4804 for ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics.’’ 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 


khammond on DSKJM1Z7X2PROD with NOTICES
1102 Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Expedited Programs for Serious 

Conditions—Drugs and Biologics 

OMB Control Number 0910–0765— 

Extension 

This information collection supports 

regulations governing FDA expedited 

programs for serious conditions. These 

provisions are set forth in 21 CFR part 

312, subpart E and are intended to 

speed the availability of new therapies 

to patients with serious conditions, 

especially when there are no satisfactory 

alternative therapies, while preserving 

appropriate standards for safety and 

effectiveness. The regulations call for 

earlier attention to drugs that have 

promise in treating such conditions, 

including early consultation with FDA 

for sponsors of such products. 

Respondents to the information 

collection are sponsors of drug or 

biologic product applications submitted 

to FDA. 

To assist respondents with the 

information collection, we developed 

Agency guidance entitled ‘‘Guidance for 

Industry Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ (May 

2014). The guidance is a resource for 

information on FDA’s policies and 

procedures related to the following 

expedited programs for serious 

conditions: (1) fast track designation, (2) 

breakthrough therapy designation, (3) 

accelerated approval, and (4) priority 

review designation, and describes 

threshold criteria generally applicable to 

expedited programs, including what is 

meant by serious condition, unmet 

medical need, and available therapy. 

The guidance addresses the 

applicability of expedited programs to 

rare diseases, clarification on available 

therapy, and additional detail on 

possible flexibility in manufacturing 

and product quality. It also clarifies the 

qualifying criteria for breakthrough 

therapy designation, provides examples 

of surrogate endpoints and intermediate 

clinical endpoints used to support 

accelerated approval, and priority 

review. 

In addition, we developed Agency 

guidance entitled ‘‘Expedited Programs 

for Regenerative Medicine Therapies for 

Serious Conditions,’’ (February 2019) 

describing the criteria for participation 

in the Regenerative Medicine Advanced 

Therapy (RMAT) program. The RMAT 

expedited program was approved as part 

of the 21st Century CURES Act, signed 

December 13, 2016. An RMAT product 

is intended to treat, modify, reverse, or 

cure serious or life-threatening diseases 

or conditions, and preliminary clinical 

evidence indicate that the drug has the 

potential to address unmet medical 

needs for such diseases or conditions. 

This is a Center Biologics Evaluation 

and Research (CBER) program and is 

included as an expedited program 

available for serious conditions. 

For a sponsor or applicant who seeks 

fast track, priority, breakthrough, RMAT 

or accelerated approval designation 

review, approval is required to submit a 

request showing that the drug product: 

(1) is intended for a serious or lifethreatening condition and (2) has the 

potential to (a) address an unmet 

medical need, (b) demonstrate 

substantial improvement over available 

therapy, or (c) fill an unmet need to be 

approved based on a surrogate endpoint. 

We expect that most information to 

support a designation request will have 

been gathered under existing 

requirements for preparing an 

investigational new drug (IND), new 

drug application (NDA), or biologics 

license application (BLA). If such 

information has already been submitted 

to us, the information may be 

summarized in the designation request. 

A designation request should include, 

where applicable, additional 

information not specified elsewhere by 

statute or regulation. For example, 

additional information may be needed 

to show that a product has the potential 

to address an unmet medical need 

where an approved therapy exists for 

the serious or life-threatening condition 

to be treated. Such information may 

include clinical data, published reports, 

summaries of data and reports, and a list 

of references. The amount of 

information and discussion in a 

designation request should be sufficient 

to permit a reviewer to assess whether 

the criteria for fast track, priority, 

breakthrough, RMAT or accelerated 

approval designation have been met. 

After we make an expedited programs 

designation, a sponsor or applicant may 

submit a premeeting package that may 

include additional information 

supporting a request to participate in 

certain expedited programs. The 

premeeting package serves as 

background information for the meeting 

and should support the intended 

objectives of the meeting. As with the 

request for expedited programs 

designation, we expect that most 

sponsors or applicants will have 

gathered such information to meet 

existing requirements for preparing an 

IND, NDA, or BLA. These may include 

descriptions of clinical safety and 

efficacy trials not conducted under an 

IND (e.g., foreign studies) and 

information to support a request for 

accelerated approval. If such 

information has already been submitted 

to us, the information may be 

summarized in the premeeting package. 

The guidance documents are available 

on our website at www.fda.gov/ 

regulatory-information/search-fdaguidance-documents and were issued 

consistent with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

We estimate the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1103 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER 

Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section 

VIII) ................................................................................... 81 1.53 124 30 3,720 

Breakthrough Therapy Designation Requests (EPSC Section VI) .............................................................................. 71 1.08 77 70 5,390 

Fast Track Designation Requests (EPSC Section V) ......... 235 1.18 277 60 16,620 

Accelerated Approval Designation (EPSC Section VII) ...... 26 1.27 33 100 3,300 

Premeeting Packages (21 CFR 312.82) ............................. 163 1.01 165 100 16,500 

CDER Subtotal ............................................................. ........................ ........................ 676 ........................ 45,530 

CBER 

Priority Review Designation Request (EPSC Section VIII) 8 1 8 30 240 

Breakthrough Therapy Designation Request (EPSC Section VI) .............................................................................. 15 1.1 17 70 1,190 

Fast Track Designation Requests (EPSC Section VII) ....... 64 1.2 77 60 4,620 

RMAT Designation Requests (Regenerative Medicine 

Therapies for Serious Conditions Guidance (RMAT) 

Section III) ........................................................................

Guidance p 6) ...................................................................... 33 1.1 36 60 2,160 

Premeeting Packages (RMAT Section V) ........................... 146 1.9 277 100 27,700 

CBER Subtotal .............................................................. ........................ ........................ 415 ........................ 35,910 

Total ....................................................................... ........................ ........................ 1,091 ........................ 81,440 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FY 2022 receipts, we 

estimate that for Center for Drug 

Evaluation and Research (CDER) 

products, 81 respondents will submit 

124 requests for priority review 

designation annually, and we assume 30 

hours are needed to prepare such a 

request. We estimate 71 respondents 

will submit 77 requests for breakthrough 

designation annually, and we assume 70 

hours are needed to prepare such a 

request. We estimate that 235 

respondents will submit 277 requests 

for fast-track designation requests 

annually, and we assume 60 hours are 

required to prepare such a request. We 

estimate 26 respondents will submit 33 

accelerated approval designation 

requests annually and we assume 100 

hours are required to prepare such a 

request. Finally, CDER received 165 premeeting package submissions from 163 

respondents. We assume 100 hours are 

needed to prepare a pre-meeting 

package. 

Similarly, also based on FY 2022 

receipts, we estimate that for CBER 

products, 8 applicants will submit 8 

requests for priority review designation 

annually, and we assume 30 hours are 

required to prepare such a request. We 

estimate 15 respondents will submit 17 

requests for breakthrough designation 

annually, and we assume 70 hours are 

needed to prepare such a request. We 

estimate that 64 respondents will 

submit 78 requests for fast-track 

designation annually, and we assume 60 

hours is required to prepare such a 

request. We also estimate 33 

respondents will submit 35 requests for 

RMAT designation annually and assume 

that 60 hours are needed to prepare each 

RMAT designation request. Finally, 

CBER received 283 pre-meeting package 

submissions from 146 respondents. We 

assume 100 hours are needed to prepare 

a pre-meeting package. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have increased our 

burden estimate by 143 responses and 

10,350 hours to reflect actual 

submissions we have received. We 

attribute these changes to increased 

interest in the expedited programs, new 

expedited programs, and an increase in 

the number of submissions we received 

over the last few years. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00217 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Bureau of 

Health Workforce Performance Data 

Collection, OMB No. 0915–0061— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 8, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 


khammond on DSKJM1Z7X2PROD with NOTICES