9058 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 

regulations in part 820 (21 CFR part 

820), which govern the methods used 

in, and the facilities and controls used 

for, the design, manufacture, packaging, 

labeling, storage, installation, and 

servicing of all finished devices 

intended for human use. Manufacturers 

are required to maintain complaint files 

and to review and evaluate complaints 

for these devices under § 820.198 (21 

CFR 820.198) (approved under OMB 

control number 0910–0073). 

Complaints required to be reported in 

the annual logs under the proposed 

special controls, such as certain 

complaints involving unusually high 

invalid rates or issues with users 

conducting the test, may not meet the 

definition of a medical device report 

required to be reported to FDA under 21 

CFR part 803 (Medical Device 

Reporting; currently approved under 

OMB control number 0910–0437), but 

could potentially affect the safety and 

effectiveness of these devices. The 

submission of the complaint log would 

provide us with earlier notification of 

concerns and enable us to determine 

whether they have been adequately 

addressed. The Agency usually would 

not evaluate this kind of complaint 

information until an FDA inspection, 

which typically occurs less frequently 

than annually. We believe 

implementing these specific reporting 

measures as part of the special controls 

would be necessary to provide a 

reasonable assurance of safety and 

effectiveness for HIV diagnostic and 

supplemental tests subject to the 

proposed order. 

Finalizing the proposed order would 

add classification regulations for these 

devices in 21 CFR part 866 

(Immunology and Microbiology 

Devices) at 21 CFR 866.3956 for the HIV 

serological diagnostic and supplemental 

tests, and 21 CFR 866.3957 for the HIV 

NAT diagnostic and supplemental tests, 

and establish special controls necessary 

to provide reasonable assurance of their 

safety and effectiveness. As described 

above, the special controls would 

require the submission of a log of all 

complaints annually for a period of 5 

years following FDA clearance of a 

traditional 510(k) submission for one of 

these devices. We are requesting 

approval to revise the scope of the 

information collections included in 

OMB control number 0910–0437 

(medical device reporting) to include 

the information collection associated 

with this special control provision. 

Description of Respondents: The 

respondents to the information 

collection are manufacturers of HIV 

diagnostic and supplemental test 

devices that would be subject to the 

proposed order, if finalized. 

In the Federal Register of June 25, 

2021 (86 FR 33708), we published a 60- 

day notice requesting public comment 

on the new reporting provisions of the 

proposed order. One comment was 

received, however it was not responsive 

to the four information collection topics 

solicited, nor did it suggest FDA revise 

its burden estimate. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Proposed 21 CFR 866.3956(b)(1)(iii) and 

866.3957(b)(1)(iii), Submission of log to FDA ................. 10 1 10 3 30 

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

We base our estimate of the average 

burden per response on our experience 

with other types of annual report 

submissions. We base our estimate of 

the number of affected respondents on 

the expected number of manufacturers 

that would be submitting a 510(k) for a 

new device or changes to an existing 

device that would require a 510(k). 

As noted above, manufacturers of the 

devices subject to the proposed order 

must already maintain complaint files 

and review and evaluate complaints 

under § 820.198. If the proposed order is 

finalized as proposed, we estimate it 

would take a manufacturer 

approximately 3 hours annually to 

review their existing records, prepare 

the complaint log, and submit it to FDA. 

Although respondents may submit the 

information electronically through the 

FDA Electronic Submission Gateway, on 

paper, or electronic media (e.g., CD, 

DVD) to the Center for Biologics 

Evaluation and Research’s Document 

Control Center, we assume that all 

manufacturers will submit their logs 

electronically. 

Dated: February 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03437 Filed 2–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1721] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Investigational 

New Drug Application Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 March 21, 

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 0910–0014. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 


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Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 9059 

collection of information to OMB for 

review and clearance. 

Investigational New Drug Application 

Regulations—21 CFR part 312 

OMB Control Number 0910–0014— 

Revision 

This information collection supports 

implementation of provisions of section 

505 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355) and of the licensing provisions of 

the Public Health Service Act (42 U.S.C. 

201 et seq.) that govern investigational 

new drugs and investigational new drug 

applications (INDs). Implementing 

regulations are found in part 312 (21 

CFR part 312), and provide for the 

issuance of guidance documents (see 

§ 312.145 (21 CFR 312.145)) to assist 

persons in complying with the 

applicable requirements. The 

information collection applies to all 

clinical investigations subject to section 

505 of the FD&C Act and include the 

following types of INDs: 

• An Investigator IND is submitted by 

a physician who both initiates and 

investigates, and under whose 

immediate direction the investigational 

drug is administered or dispensed. A 

physician might submit a research IND 

to propose studying an unapproved 

drug or an approved product for a new 

indication or in a new patient 

population. 

• Emergency Use IND allows FDA to 

authorize use of an experimental drug in 

an emergency situation that does not 

allow time for submission of an IND in 

accordance with § 312.23 or § 312.20 (21 

CFR 312.23 or 312.20). It is also used for 

patients who do not meet the criteria of 

an existing study protocol or if an 

approved study protocol does not exist. 

• Treatment IND is submitted for 

experimental drugs showing promise in 

clinical testing for serious or 

immediately life-threatening conditions 

while the final clinical work is 

conducted and FDA’s review takes 

place. 

There are two IND categories: 

Commercial and research (noncommercial). 

General IND requirements include 

submitting an initial application as well 

as amendments to that application; 

submitting reports on significant 

revisions of clinical investigation plans; 

submitting information to the clinical 

trials data bank (https://

clinicaltrials.gov) established by the 

National Institutes of Health/National 

Library of Medicine, including 

expanded information on certain 

clinical trials and information on the 

results of these clinical trials; and 

reporting information on a drug’s safety 

or effectiveness. In addition, sponsors 

are required to provide to FDA an 

annual summary of the previous year’s 

clinical experience. The regulations also 

include recordkeeping requirements 

regarding the disposition of drugs, 

records regarding individual case 

histories, and certain other 

documentation verifying clinical 

investigators’ fulfillment of 

responsibilities. 

Form FDA 1571 entitled 

‘‘Investigational New Drug Application 

(IND)’’ and Form FDA 1572 entitled 

‘‘Statement of Investigator,’’ were 

developed to assist respondents with 

the information collection and provide 

for uniform reporting of required data 

elements. The information is required to 

be submitted electronically. Individuals 

who are interested in receiving printed 

forms may send an email request to the 

FDA Forms Manager at formsmanager@

OC.FDA.GOV. Fees may apply. 

Sponsors (including sponsorinvestigators) interested in filing or 

updating a research IND may use a new 

web-based interface developed for use 

by mobile device or desktop to help in 

completing Form FDA 1571. The webbased interface also allows respondents 

to electronically submit completed 

Form FDA 1571 and associated files. For 

more information regarding Forms FDA 

1571 and 1572 visit https://

www.fda.gov/news-events/expandedaccess/how-complete-form-fda-1571- 

and-form-fda-1572. 

Human drug, biological product, and 

device product submissions must be 

accompanied by Form FDA 3674, as 

discussed in the guidance document 

entitled ‘‘Form FDA 3674— 

Certifications To Accompany Drug, 

Biological Product, and Device 

Applications/Submissions’’ (updated 

November 2017), available from our 

website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/form-fda-3674- 

certifications-accompany-drugbiological-product-and-deviceapplicationssubmissions. The guidance 

document provides procedural 

instruction on completing and 

submitting required information to FDA. 

As communicated in the instructions, 

the certification must accompany the 

application or submission and be 

included at the time of submission to 

FDA. 

Regulations in part 312, subpart B, 

specify content and format requirements 

for applications, amendments, annual 

reporting, and withdrawals, including 

content and format requirements for 

protocol and information amendments. 

The regulations also explain phases of 

an investigation and set forth principles 

of IND submissions. 

Regulations in part 312, subpart C, 

describe administrative actions 

pertaining to respondents’ requests for 

and responses to clinical holds, 

terminations, and inactive IND status 

determinations, as well as various types 

of meetings (for example, End-of-Phase 

2 and Pre-new drug application (NDA) 

meetings). 

Regulations in part 312, subpart D, set 

forth sponsor and investigator 

responsibilities, including general 

responsibilities; transfer of obligations 

to a contract research organization; 

recordkeeping and record retention 

controls; reporting responsibilities; and 

responsibility for disposition of unused 

supply of investigational drug. The 

regulations also provide for investigator 

controls including review of ongoing 

investigations; compliance with 

requirements regarding the protection of 

human subjects and institutional review 

board assurance; and disqualification of 

clinical investigators. 

Regulations in part 312, subpart E, 

sets forth requirements applicable to 

drugs intended to treat life-threatening 

and severely debilitating illnesses. The 

regulations establish procedures to 

reflect that physicians and patients 

accept greater risk or side effects from 

products that treat life-threatening and 

severely debilitating illnesses than they 

would accept from products that treat 

less serious illnesses. The procedures 

also reflect the recognition that the 

benefits of the drug need to be evaluated 

in light of the severity of the disease 

being treated. 

Regulations in part 312, subpart F, 

include provisions pertaining to import 

and export requirements; foreign 

clinical studies not conducted under an 

IND; the disclosure of data and 

information in an IND; and the issuance 

of guidance documents. We are revising 

the information collection to account for 

burden that may be associated with 

recommendations found in Agency 

guidance documents. 

• The guidance document entitled 

‘‘Oversight of Clinical Investigations’’ 

(August 2013) communicates risk-based 

monitoring strategies and recommends 

plans for investigational studies of 

medical products, including human 

drug and biological products, medical 

devices, and combinations thereof. The 

guidance document is intended to 

enhance human subject protection and 

the quality of clinical trial data by 

focusing sponsor oversight on the most 

important aspects of study conduct and 

reporting. The guidance also 

communicates that sponsors can use a 

variety of approaches to fulfill 


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9060 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 

responsibilities for monitoring clinical 

investigator conduct and performance in 

IND studies, and provides a description 

of strategies for monitoring activities to 

reflect a modern, risk-based approach. 

The guidance document recommends 

that respondents develop a written 

comprehensive monitoring plan and 

describes monitoring approaches for 

respondents to consider (Guidance 

Section IV.D.). 

• The guidance document entitled 

‘‘Pharmacogenomic Data Submissions’’ 

(March 2005) provides 

recommendations intended to assist 

sponsors submitting or holding INDs, 

NDAs, or biologics license applications 

(BLAs) with submission requirements 

for relevant data regarding drug safety 

and effectiveness (including §§ 312.22, 

312.23, 312.31, 312.33, 314.50, 314.81, 

601.2, and 601.12 (21 CFR 312.22, 

312.23, 312.31, 312.33, 314.50, 314.81, 

601.2 and 601.12)). Because the 

regulations were developed before the 

advent of widespread animal or human 

genetic or gene expression testing, the 

regulations do not specifically address 

when such data must be submitted. The 

guidance document includes content 

and format recommendations regarding 

pharmacogenomic data submissions. 

Although we have not received any 

pharmacogenomic submissions since 

2013, we assume an average of 50 hours 

for preparing and providing information 

to FDA as recommended in the 

guidance and estimate one submission 

annually. 

• The guidance document entitled 

‘‘Adaptive Designs for Clinical Trials of 

Drugs and Biologics’’ (December 2019) 

was developed to assist sponsors and 

applicants submitting INDs, NDAs, 

BLAs, or supplemental applications on 

the appropriate use of adaptive designs 

for clinical trials to provide evidence of 

the effectiveness and safety of a drug or 

biologic. The guidance document 

describes important principles for 

designing, conducting, and reporting the 

results from an adaptive clinical trial, 

and advises sponsors on the types of 

information to submit to facilitate FDA 

evaluation of clinical trials with 

adaptive designs, including Bayesian 

adaptive and complex trials that rely on 

computer simulations for their design. 

The guidance document also helps to 

fulfill FDA Commitment Goals under 

the Prescription Drug User Fee Act 

pertaining to the enhancement of 

regulatory decision tools. 

The referenced guidance documents 

are available for download from our 

website at https://www.fda.gov/ 

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

consistent with § 312.145 to help 

respondents comply with requirements 

in part 312. In publishing the respective 

notices of availability for each guidance 

document, we included an analysis 

under the PRA and invited public 

comment on the associated information 

collection recommendations. In 

addition, all Agency guidance 

documents are issued in accordance 

with our Good Guidance Practice 

regulations in 21 CFR 10.115, which 

provide for public comment at any time. 

Regulations in part 312, subpart G, 

provide for drugs for investigational use 

in laboratory research animals or in 

vitro tests. 

In the Federal Register of November 

24, 2021 (86 FR 67060), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although we received two 

general comments, neither discussed the 

four information collection topics 

solicited in our 60-day notice or 

suggested that we revise our burden 

estimate. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Subpart A—General Provisions: §§ 312.1 through 312.10 

§ 312.2(e); requests for FDA advice on the applicability of 

part 312 to a planned clinical investigation ...................... 454 1.528 694 24 16,656 

§ 312.8; requests to charge for an investigational drug ...... 14 1.64 23 48 1,104 

§ 312.10; waiver requests .................................................... 5 1 5 24 120 

Subtotal Subpart A Center for Biologics Evaluation 

and Research (CBER) .............................................. ........................ ........................ 722 ........................ 17,880 

Subpart B—Investigational New Drug Application (IND): §§ 312.20 through 312.38 (Including Forms FDA 1571, 1572, and 3674) 

§ 312.23(a) through (f); IND content and format ................. 2,075 3.382 7,018 300 2,105,400 

§ 312.30(a) through (e); protocol amendments ................... 1,781 4.6692 8,316 284 2,361,744 

§ 312.31(b); information amendments ................................. 169 2.48 419 100 41,900 

§ 312.32(c) and (d); IND safety reports ............................... 224 10.59 2,372 32 75,904 

§ 312.33(a) through (f); IND annual reports ........................ 971 2.2739 2,208 360 794,880 

§ 312.38(b) and (c); notifications of withdrawal of an IND .. 712 3.057 2,177 28 60,956 

Subtotal Subpart B CBER ............................................ ........................ ........................ 22,510 ........................ 5,440,784 

Subpart C—Administrative Actions: §§ 312.40 through 312.48 

§ 312.42; clinical holds and requests for modification ......... 154 1.65 254 284 72,136 

§ 312.44(c) and (d); sponsor responses to FDA when IND 

is terminated ..................................................................... 86 1.22 105 16 1,680 

§ 312.45(a) and (b); sponsor requests for or responses to 

an inactive status determination of an IND by FDA ........ 48 1.48 71 12 852 

§ 312.47; meetings, including ‘‘End-of-Phase 2’’ meetings 

and ‘‘Pre-NDA’’ meetings ................................................. 157 1.80 283 160 45,280 

Subtotal Subpart C CBER ............................................ ........................ ........................ 713 ........................ 119,948 


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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued 

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Subpart D—Responsibilities of Sponsors and Investigators: §§ 312.50 through 312.70 

§ 312.53(c); investigator reports submitted to the sponsor, 

including Form FDA 1572, curriculum vitae, clinical protocol, and financial disclosure .......................................... 1,068 5.23 5,586 80 446,880 

§ 312.54(a); sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 ............................................................ 4 4.25 17 48 816 

§ 312.54(b); sponsor notifications to FDA and others concerning an institutional review board determination that 

it cannot approve research because it does not meet 

the criteria in the exception from informed consent in 

§ 50.24(a) .......................................................................... 1 1 1 48 48 

§ 312.55(a); number of investigator brochures submitted 

by the sponsor to each investigator ................................. 473 2.224 1,052 48 50,496 

§ 312.55(b); number of sponsor reports to investigators on 

new observations, especially adverse reactions and safe 

use .................................................................................... 243 4.95 1,203 48 57,744 

§ 312.56(b), (c), and (d); review of ongoing investigations 

and associated notifications; sponsor notifications .......... 915 2.948 2,698 80 215,840 

§ 312.58; inspection of records and reports by FDA ........... 7 1 7 8 56 

§ 312.64; number of investigator reports to the sponsor, including progress reports, safety reports, final reports, 

and financial disclosure reports ....................................... 2,728 3.816 10,411 24 249,864 

§ 312.70; disqualification of a clinical investigator by FDA 5 1 5 40 200 

Subtotal Subpart D CBER ............................................ ........................ ........................ 20,980 ........................ 1,021,944 

Subpart F—Miscellaneous: §§ 312.110 through 312.145 

§ 312.110(b)(4) and (b)(5); number of written certifications 

and written statements submitted to FDA relating to the 

export of an investigational drug ...................................... 18 1 18 75 1,350 

§ 312.120(b); number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical 

studies not conducted under an IND ............................... 280 9.82 2,750 32 88,000 

§ 312.120(c); number of waiver requests submitted to FDA 

related to the use of foreign clinical studies not conducted under an IND ........................................................ 7 2.29 16 24 384 

§ 312.130; number of requests for disclosable information 

in an IND and for investigations involving an exception 

from informed consent under § 50.24 .............................. 350 1.342 470 8 3,760 

Subtotal Subpart F CBER ............................................ ........................ ........................ 3,254 ........................ 93,494 

Total ....................................................................... ........................ ........................ 48,179 ........................ 6,694,050 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Subpart D—Responsibilities of Sponsors and Investigators: §§ 312.50 through 312.70 

§ 312.52(a); sponsor records for the transfer of 

obligations to a contract research organization.

94 2.26 212 2 ...................................... 424 

§ 312.57; sponsor recordkeeping showing the 

receipt, shipment, or other disposition of the 

investigational drug, and any financial interest.

335 2.70 904 100 .................................. 90,400 

§ 312.62(a); investigator recordkeeping of the 

disposition of drugs.

453 1 453 40 .................................... 18,120 

§ 312.62(b); investigator recordkeeping of case 

histories of individuals.

453 1 453 40 .................................... 18,120 

Subtotal Subpart D CBER ........................... ........................ ........................ 2,022 ......................................... 127,064 


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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1—Continued 

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests 

§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.111 1.40 155 0.5 (30 minutes) ............. 78 

§ 312.160(c) shipper records of alternative disposition of unused drugs.111 1.40 155 0.5 (30 minutes) ............. 78 

Subtotal Subpart G CBER ........................... ........................ ........................ 310 ......................................... 156 

Total ...................................................... ........................ ........................ 2,332 ......................................... 127,220 

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

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Subpart A—General Provisions 

§ 312.2(e); requests for FDA advice on the applicability of 

part 312 to a planned clinical investigation ...................... 419 1 419 24 10,056 

§ 312.8; requests to charge for an investigational drug ...... 25 1.28 32 48 1,536 

§ 312.10; requests to waive a requirement in part 312 ....... 68 1.5 102 24 2,448 

Subtotal Subpart A Center for Drug Evaluation and 

Research (CDER) ..................................................... ........................ ........................ 553 ........................ 14,040 

Subpart B—Investigational New Drug Application (IND) 

§ 312.23(a) through (f); IND content and format (including 

Forms FDA 1571 and 3674) ............................................ 4,886 1.4662 7,164 300 2,149,200 

§ 312.30(a) through (e); protocol amendments ................... 11,847 3.2367 38,346 284.25 10,899,850 

§ 312.31(b); information amendments ................................. 8,094 3.30899 26,783 100 2,678,300 

§ 312.32(c) and (d); IND safety reports ............................... 892 15.848 14,137 32 452,384 

§ 312.33(a) through (f); IND annual reports ........................ 3,777 2.9097 10,990 360 3,956,400 

§ 312.38(b) and (c); notifications of withdrawal of an IND .. 1,549 1.834 2,841 28 79,548 

Subtotal Subpart B CDER ............................................ ........................ ........................ 100,261 ........................ 20,215,682 

Subpart C—Administrative Actions: §§ 312.40 through 312.48 

§ 312.42; clinical holds and requests for modifications ....... 181 1.28 232 284 65,888 

§ 312.44(c) and (d); sponsor responses to FDA when IND 

is terminated ..................................................................... 1 1 1 16 16 

§ 312.45(a) and (b); sponsor requests for or responses to 

an inactive status determination of an IND by FDA ........ 213 1.72 367 12 4,404 

§ 312.47; meetings, including ‘‘End-of-Phase 2’’ meetings 

and ‘‘Pre-NDA’’ meetings ................................................. 174 2.885 502 160 80,320 

Subtotal Subpart C CDER ............................................ ........................ ........................ 1,102 ........................ 150,628 

Subpart D—Responsibilities of Sponsors and Investigators 

§ 312.54(a); sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 ............................................................ 7 1.14 8 48 384 

§ 312.54(b); sponsor notifications to FDA and others concerning an institutional review board determination that 

it cannot approve research because it does not meet 

the criteria in the exception from informed consent in 

§ 50.24(a) .......................................................................... 2 1 2 48 96 

§ 312.56; review of ongoing investigations and associated 

notifications ....................................................................... 4,570 5.4689 24,993 80 1,999,440 

§ 312.58; inspection of records and reports by FDA ........... 73 1 73 8 584 

§ 312.70; disqualification of a clinical investigator by FDA. 5 1 5 40 200 

Subtotal Subpart D CDER ............................................ ........................ ........................ 25,081 ........................ 2,000,704 


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TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued 

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Subpart F—Miscellaneous: §§ 312.110 through 312.145 

§ 312.110(b)(4) and (b)(5); written certifications and written 

statements submitted to FDA relating to the export of an 

investigational drug .......................................................... 8 22.375 179 75 13,425 

§ 312.120(b); submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not 

conducted under an IND .................................................. 1,964 7.352 14,440 32 462,080 

§ 312.120(c); waiver requests submitted to FDA related to 

the use of foreign clinical studies not conducted under 

an IND .............................................................................. 68 1.5 102 24 2,448 

§ 312.130; requests for disclosable information in an IND 

and for investigations involving an exception from informed consent under § 50.24 ......................................... 3 1 3 8 24 

§ 312.145; Guidance Documents: 

Oversight of Clinical Investigations (2013) ................... 88 1.5 132 4 528 

Pharmacogenomic Data Submissions (2005) .............. 1 1 1 50 50 

Adaptive Designs for Clinical Trials of Drugs and Biologics (2019) .............................................................. 55 4.727 260 50 13,000 

Subtotal Subpart F CDER ......................................... ........................ ........................ 15,117 ........................ 491,555 

Total ....................................................................... ........................ ........................ 142,114 ........................ 22,872,609 

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

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Subpart D—Responsibilities of Sponsors and Investigators 

§ 312.52(a); transfer of obligations to a contract 

research organization.

466 3.107 1,448 300 .................................. 434,400 

§ 312.57; records showing the receipt, shipment, or other disposition of the investigational drug and any financial interests.13,000 1 13,000 100 .................................. 1,300,000 

§ 312.62(a); records on disposition of drugs ...... 13,000 1 13,000 40 .................................... 520,000 

§ 312.62(b); records on case histories of individuals.2,192 6.587 14,439 40 .................................... 577,560 

Subtotal Subpart D CDER ........................... ........................ ........................ 41,887 ......................................... 2,831,960 

Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests 

§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.547 1.43 782 0.50 (30 minutes) ........... 391 

§ 312.160(c); shipper records of alternative disposition of unused drugs.547 1.43 782 0.50 (30 minutes) ........... 391 

Subtotal .................................................... ........................ ........................ 1,564 ......................................... 782 

Total ...................................................... ........................ ........................ 43,451 ......................................... 2,832,742 

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

The information collection reflects 

program changes and adjustments. We 

have revised the information collection 

to account for burden that may be 

incurred by respondents who choose to 

adopt or implement recommendations 

discussed in referenced Agency 

guidance documents intended to assist 

respondents in complying with 

regulatory requirements in part 312. We 

have also made adjustments to 

individual collection elements, 

specifically with regard to protocol 

amendments and emergency INDs for 

both human drugs and biological drugs. 

We attribute the increase for these 

elements to a corresponding increase in 

submissions since last OMB review and 

approval of the information collection 

and the ongoing public health 

emergency. Finally, we have removed 

burden we attribute to provisions in part 

312, subpart I: Expanded Access to 

Investigational Drugs for Treatment Use 

and are revising OMB control number 

0910–0814 to include burden associated 

with information collection applicable 


lotter on DSK11XQN23PROD with NOTICES1
9064 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 

to these regulatory provisions for 

efficiency of Agency operations. As a 

result of these cumulative changes and 

adjustments, the information collection 

reflects an overall decrease in both 

annual responses and burden hours. 

Dated: February 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03432 Filed 2–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0895] 

Issuance of Priority Review Voucher; 

Material Threat Medical 

Countermeasure Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a material threat medical 

countermeasure (MCM) product 

application. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

COMIRNATY (COVID–19 Vaccine, 

mRNA) was approved on August 23, 

2020, and a license was issued to 

BioNTech Manufacturing GmbH. FDA 

has determined that COMIRNATY 

(COVID–19 Vaccine, mRNA) meets the 

criteria for a material threat MCM 

priority review voucher, which has been 

issued to BioNTech Manufacturing 

GmbH. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a material 

threat MCM priority review voucher to 

the sponsor of an approved material 

threat MCM product application. Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a), which was added by the 

Cures Act (Pub. L. 114–255), FDA will 

award priority review vouchers to 

sponsors of approved material threat 

MCM product applications that meet 

certain criteria upon approval of those 

applications. FDA has determined that 

COMIRNATY (COVID–19 Vaccine, 

mRNA) meets the criteria for a material 

threat MCM priority review voucher, 

which has been issued to BioNTech 

Manufacturing GmbH. COMIRNATY is 

indicated for active immunization to 

prevent coronavirus disease 2019 

(COVID–19) caused by severe acute 

respiratory syndrome coronavirus 2 

(SARS–CoV–2) in individuals 16 years 

of age and older. 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further 

information about COMIRNATY 

(COVID–19 Vaccine, mRNA) go to the 

Center for Biologics Evaluation and 

Research Approved Vaccine Products 

website at https://www.fda.gov/ 

vaccines-blood-biologics/vaccines/ 

approved-vaccine-products. 

Dated: February 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03426 Filed 2–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0410] 

Peripheral and Central Nervous 

System Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Peripheral and Central 

Nervous System Drugs Advisory 

Committee. The general function of the 

committee is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will take place 

virtually on March 30, 2022, from 10 

a.m. to 4:30 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–0410. 

The docket will close on March 29, 

2022. Submit either electronic or 

written comments on this public 

meeting by March 29, 2022. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before March 

29, 2022. The https://

www.regulations.gov electronic filing 

system will accept comments until 

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

March 29, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Comments received on or before 

March 16, 2022, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 


lotter on DSK11XQN23PROD with NOTICES1