25282 Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 

under different circumstances, with a 

small number requiring more hours 

(e.g., as many as 5,000 hours for early 

applications that involve complex 

products and for which the company 

has no experience conducting studies or 

preparing analysis of public health 

impacts, or for which reliance on master 

files is not possible) as well as many 

requiring fewer hours (e.g., as few as 50 

hours for applications for products that 

are very similar to other new products). 

A PMTA may require one or more types 

of studies including chemical analysis, 

nonclinical studies, and clinical studies. 

FDA also estimates the number of 

PMTAs that FDA expects to receive 

annually will be 750 (642 electronic 

nicotine delivery systems (ENDS) 

Liquids and 108 ENDS Delivery 

Systems). 

FDA anticipates that the 27 potential 

respondents to this collection may need 

to meet with CTP’s Office of Science to 

discuss their investigational plans. This 

number has been reduced based on the 

average number of meeting requests 

received over the past 3 years. To 

request this meeting, applicants should 

compile and submit information to FDA 

for meeting approval. FDA estimates 

that it will take approximately 270 

hours to compile and request a meeting 

with OS. We have revised the hours per 

response to be consistent with the 

meetings information collection for 

originally regulated products (OMB 

control number 0910–0731). 

Based on the September 2020 order 

vacating the health warning 

requirements for cigars and pipe tobacco 

(set forth in §§ 1143.3 and 1143.5) and 

remanding the Final Deeming Rule’s 

warning requirements for cigars and 

pipe tobacco, we have removed the 

burden associated with this activity. We 

have included one token hour of burden 

associated with the requirements in 

§ 1143 to acknowledge the requirement 

remains in the regulations. 

We have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden. The total estimated burden for 

this information collection is 1,285,021 

reporting hours, and 778 annual 

responses. Our estimated burden for the 

information collection reflects an 

overall decrease of 2,779 hours and a 

corresponding decrease of 262 

responses. We attribute this adjustment 

to updated information in the number of 

meeting requests with CTP’s Office of 

Science to discuss investigational plans, 

the removal of burden for the cigar 

warning plans, the removal of the smallscale manufacturer reporting, and have 

therefore revised the estimated burden 

and number of respondents to the 

information collection. 

Dated: April 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09072 Filed 4–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3758] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Expanded Access 

to Investigational Drugs for Treatment 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by May 31, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0814. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Expanded Access to Investigational 

Drugs for Treatment Use 

OMB Control Number 0910–0814— 

Revision 

This information collection supports 

Agency regulations in 21 CFR part 312, 

subpart I, Expanded Access to 

Investigational Drugs for Treatment Use; 

associated guidance; and Form FDA 

3926, Individual Patient Expanded 

Access Investigational New Drug 

Application (IND). The regulations 

govern the use of investigational new 

drugs, biologics, and approved drugs if 

availability is limited by a risk 

evaluation and mitigation strategy, 

when the primary purpose is to 

diagnose, monitor, or treat a patient’s 

disease or condition. The goal of the 

expanded access program is to facilitate 

the availability of such products to 

patients with serious diseases or 

conditions when there is no comparable 

or satisfactory alternative therapy to 

diagnose, monitor, or treat the patient’s 

disease or condition. The regulations 

provide that certain criteria be met, 

establish content and format 

requirements for associated reporting, 

and require that submissions include a 

cover sheet. 

Although we continue to account for 

burden associated with the submission 

of expanded access requests for 

individual patients, we are revising the 

information collection to also account 

for burden attendant to other expanded 

access submissions, including 

commercial investigational new drug 

applications (INDs) that involve large 

groups of patients enrolled for treatment 

use of the investigational drug 

(§§ 312.300 through 312.320 (21 CFR 

312.300 through 312.320)), currently 

approved under OMB control number 

0910–0014. Because of FDA’s long 

history of facilitating expanded access 

to investigational drugs for treatment 

use for patients with serious or 

immediately life-threatening diseases or 

conditions, our efforts in this regard are 

ongoing. 

Form FDA 3926 was developed to 

assist respondents to the information 

collection. Form FDA 3926 requires the 

completion of data fields that enable us 

to uniformly collect the minimum 

information necessary from licensed 

physicians who want to request 

expanded access as prescribed in the 

applicable regulations. To supplement 

the form instructions, we issued 

guidance, most recently updated in 

October 2017, entitled ‘‘Individual 

Patient Expanded Access Applications: 

Form FDA 3926,’’ available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 


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Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 25283 

individual-patient-expanded-accessapplications-form-fda-3926. As 

discussed in the guidance, § 312.310(b) 

contains additional submission 

requirements for individual patient 

expanded access requests. These 

respondents may continue to use either 

Form FDA 3926 or Form FDA 1571, 

Investigational New Drug Application 

(IND), for all types of IND submissions 

to satisfy requirements in 21 CFR 

312.23(a) (approved under OMB control 

number 0910–0014). FDA considers a 

completed Form FDA 3926 signed by 

the physician and checked in the box in 

Field 10.a (Request for Authorization to 

use Form FDA 3926) to be a waiver 

request in accordance with 21 CFR 

312.10. 

We are proposing the following 

revisions to data elements in Form FDA 

3926 and will make corresponding 

revisions to the form instructions: 

• Reorder Field 8, ‘‘Physician Name, 

Address, and Contact Information’’ to 

Field 1, and renumber remaining data 

fields accordingly; 

• Add ‘‘Race and Ethnicity’’ as an 

optional item under the ‘‘Clinical 

Information/Brief Clinical History’’ 

field; 

• Add ‘‘Request for Withdrawal’’ 

under the ‘‘Contents of Submission’’ 

field; 

• Add technological enhancements to 

the electronic version of Form FDA 

3926 that utilize user-based selections to 

prompt required data field entries. 

Currently, certain fields become grayed 

out if not required for the submission 

type selected. 

Data elements in §§ 312.315 and 

312.320 continue to be reported in 

Forms FDA 1571 and 1572, Statement of 

Investigator, (approved under OMB 

control number 0910–0014). 

In the Federal Register of December 

14, 2021 (86 FR 71069), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—CENTER FOR DRUG EVALUATION AND RESEARCH 1

Part 312, subpart I; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§§ 312.310(b) and 312.305(b); submissions related to expanded access and treatment of an individual patient: 

Form FDA 3926.

1,204 2.4958 3,005 0.75 ................

(45 minutes) ...

2,254 

§ 312.310(d); submissions related to emergency use of an 

investigational new drug: Form FDA 3926.

1,265 2.843 3,596 16 ................... 57,536 

§§ 312.315(c) and 312.305(b); submissions related to expanded access and treatment of an intermediate-size 

patient population 2.

88 3.64 320 120 ................. 38,400 

§ 312.320(b); submissions related to a treatment IND or 

treatment protocol 2.

20 7 140 300 ................. 42,000 

Total .............................................................................. ........................ ........................ 7,061 ........................ 140,190 

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

2 Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910–0014. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—CENTER FOR BIOLOGICS EVALUATION AND RESEARCH 1

Part 312, subpart I; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§§ 312.310(b) and 312.305(b); number of submissions related to expanded access and treatment of an individual 

patient: Form FDA 3926 ................................................... 118 1.305 154 8 1,232 

§ 312.310(d); number of submissions related to emergency use of an investigational new drug: Form FDA 

3926 .................................................................................. 1,591 4.2137 6,704 16 107,264 

§§ 312.315(c) and 312.305(b); number of submissions related to expanded access and treatment of an intermediate-size patient population 2 ..................................... 28 1 28 120 3,360 

§ 312.320(b); number of submissions related to a treatment IND or treatment protocol 2 ..................................... 15 1 15 300 4,500 

Total .............................................................................. ........................ ........................ 6,901 ........................ 116,356 

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

2 Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910–0014. 


jspears on DSK121TN23PROD with NOTICES1
25284 Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 

The information collection reflects an 

increase in 254,750 burden hours and 

11,568 responses annually since the last 

OMB review and approval of the 

information collection. We attribute this 

to an increase in the number of 

submissions. 

Dated: April 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09070 Filed 4–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

[OMB No. 0917–0041] 

Request for Public Comment: 30-Day 

Information Collection: Indian Health 

Service Information Security Ticketing 

and Incident Reporting. 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice and request for 

comments. Request for extension of 

approval. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

Indian Health Service (IHS) invites the 

general public to take this opportunity 

to comment on the information 

collection Office of Management and 

Budget (OMB) Control Number 0917– 

0041, titled, Information Security 

Ticketing and Incident Reporting. The 

purpose of this notice is to allow 30 

days for public comment submitted 

directly to OMB. A copy of the draft 

supporting statement is available at 

www.regulations.gov (see Docket ID 

IHS_FRDOC_001). 

DATES: Comment Due Date: May 31, 

2022. Your comments regarding this 

information collection are best assured 

of having full effect if received within 

30 days of the date of this publication. 

ADDRESSES: Direct Your Comments to 

OMB: Send your comments and 

suggestions regarding the proposed 

information collection contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time to: Office of Management 

and Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Desk Officer for IHS. 

FOR FURTHER INFORMATION CONTACT: To 

request additional information, please 

contact Evonne Bennett, Information 

Collection Clearance Officer at: 

Evonne.Bennett@ihs.gov or 301–443– 

4750. 

SUPPLEMENTARY INFORMATION: This 

previously approved information 

collection project was last published in 

the Federal Register on February 17, 

2022 (87 FR 9071), and allowed 60 days 

for public comment. No public 

comment was received in response to 

the notice. This notice announces our 

intent to submit this collection, which 

expires April 30, 2022, to OMB for 

approval of an extension, and to solicit 

comments on specific aspects for the 

proposed information collection. 

Title: 0917–0041, ‘‘Information 

Security Ticketing and Incident 

Reporting.’’ 

Form(s) and Form number(s): Incident 

Reporting Form, Form F07–02b. 

OMB Control Number: 0917–0041. 

Need and Use of Information 

Collection: This information collection 

activity provides a means for federal 

employees, Tribal employees, 

contractors, and other non-federal 

employees to report IHS information 

technology (IT) security and privacy 

incidents. This information collection 

has three purposes: To notify the CSIRT 

of an incident, provide updates about an 

open incident, and indicate resolution 

of an existing incident. The information 

collection furthers the IHS’s ability to 

use secure IT, to enhance response time 

to IT incidents, and to maintain the 

agency’s healthcare information security 

posture. This information collection 

also allows IHS to process privacy 

incidents and breaches within the IHS, 

in keeping with internal and external 

requirements. 

Members of Affected Public: Federal 

employees, Tribal employees, 

contractors, and other non-federal 

employees accessing IHS IT systems. 

Status of the Proposed Information 

Collection: Extension request. 

Type of Respondents: Individuals. 

The table below provides: Types of 

data collection instruments, estimation 

of the number of respondents, number 

of responses per respondent, annual 

number of responses, average burden 

hour per response, and total annual 

burden hours. 

Data collection 

instrument(s) 

Estimated 

number 

of respondents 

Responses 

per 

respondent 

Annual 

number of 

responses 

Average 

burden hour 

per response * 

Total annual 

burden 

hours 

IHS Federal and Non-Federal Staff ..................................... 1700 1 1700 15/60 425 

Total .............................................................................. 1700 1 1700 15/60 425 

*For ease of understanding, the average burden per response is 15 minutes. There are no direct costs to respondents to report. 

Requests for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: 

(a) whether the information collection 

activity is necessary to carry out an 

agency function; 

(b) whether the agency processes the 

information collected in a useful and 

timely fashion; 

(c) the accuracy of the public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); 

(d) whether the methodology and 

assumptions used to determine the 

estimates are logical; 

(e) ways to enhance the quality, 

utility, and clarity of the information 

being collected; and 

(f) ways to minimize the public 

burden through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Elizabeth A. Fowler, 

Acting Director, Indian Health Service. 

[FR Doc. 2022–09055 Filed 4–27–22; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 


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