40252 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

product. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(for example, half the testing phase must 

be subtracted as well as any time that 

may have occurred before the patent 

was issued), FDA’s determination of the 

length of a regulatory review period for 

a human biological product will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA has approved for marketing the 

human biologic product MONJUVI 

(tafasitamab-cxix). MONJUVI is 

indicated in combination with 

lenalidomide for the treatment of adult 

patients with relapsed or refractory 

diffuse large B-cell lymphoma (DLBCL) 

not otherwise specified, including 

DLBCL arising from low grade 

lymphoma, and who are not eligible for 

autologous stem cell transplant. This 

indication is approved under 

accelerated approval based on overall 

response rate. Continued approval for 

this indication may be contingent upon 

verification and description of clinical 

benefit in a confirmatory trial(s). 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for MONJUVI (U.S. Patent 

Nos. 8,524,867; 9,803,020) from 

Xenocor, Inc., and the USPTO requested 

FDA’s assistance in determining the 

patents’ eligibility for patent term 

restoration. In a letter dated March 1, 

2021, FDA advised the USPTO that this 

human biological product had 

undergone a regulatory review period 

and that the approval of MONJUVI 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

MONJUVI is 3,806 days. Of this time, 

3,590 days occurred during the testing 

phase of the regulatory review period, 

while 216 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(i)) 

became effective: March 3, 2010. FDA 

has verified the applicant’s claim that 

the date the investigational new drug 

application became effective was on 

March 3, 2010. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): December 30, 2019. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for MONJUVI (BLA 761163) was 

initially submitted on December 30, 

2019. 

3. The date the application was 

approved: July 31, 2020. FDA has 

verified the applicant’s claim that BLA 

761163 was approved on July 31, 2020. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 610 days or 1,370 

days of patent term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14357 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0117] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Emergency Use 

Authorization of Medical Products 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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: Fax written comments on the 

collection of information by August 5, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0595. 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–45, 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 

collection of information to OMB for 

review and clearance. 

Emergency Use Authorization of 

Medical Products 

OMB Control Number 0910–0595— 

Extension 

This information collection helps 

support implementation of Agency 

policies applicable to the authorization 

for medical products for use in 

emergencies under sections 564, 564A, 

and 564B of the Federal Food, Drug, and 

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

360bbb–3, 360bbb–3a, and 360bbb–3b). 

For more information regarding 

emergency use authorization (EUA), 

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


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Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 40253 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/emergency-useauthorization. The FD&C Act permits 

the Commissioner of Food and Drugs 

(the Commissioner) to authorize the use 

of unapproved medical products, or 

unapproved uses of approved medical 

products, during an emergency declared 

under section 564 of the FD&C Act. The 

data to support issuance of an EUA 

must demonstrate that, based on the 

totality of the scientific evidence 

available to the Commissioner, 

including data from adequate and wellcontrolled clinical trials (if available), it 

is reasonable to believe that the product 

may be effective in diagnosing, treating, 

or preventing a serious or lifethreatening disease or condition (21 

U.S.C. 360bbb–3(c)). 

Also under section 564 of the FD&C 

Act, the Commissioner may establish 

conditions on issuing an authorization 

that may be necessary or appropriate to 

protect the public health. These 

conditions can include: (1) requirements 

to disseminate or disclose information 

to healthcare providers or authorized 

dispensers and product recipients; (2) 

adverse event monitoring and reporting; 

(3) data collection and analysis; (4) 

specific recordkeeping and records 

access; (5) restrictions on product 

advertising, distribution, and 

administration; and (6) limitations on 

good manufacturing practice 

requirements. As governed by statute, 

some conditions are mandatory to the 

extent practicable for authorizations of 

unapproved products, and discretionary 

for authorizations of unapproved uses of 

approved products. Some conditions 

may apply to manufacturers of an EUA 

product, while other conditions may 

apply to any person who carries out an 

activity for which the authorization is 

issued. Sections 564A and 564B of the 

FD&C Act establish streamlined 

mechanisms intended to facilitate 

preparedness and response activities 

involving certain FDA approved 

products without requiring FDA to issue 

an EUA, and set forth emergency 

dispensing order and expiration date 

extension authority. 

The guidance document entitled, 

‘‘Emergency Use Authorization of 

Medical Products and Related 

Authorities’’ (January 2017), available 

for download from our website at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/emergency-useauthorization-medical-products-andrelated-authorities, discusses FDA 

issuance of Emergency Use 

Authorizations (EUAs) under section 

564 of the FD&C Act; implementation of 

the emergency use authorities set forth 

in section 564A of the FD&C Act; 

reliance on the governmental prepositioning authority set forth in section 

564B of the FD&C Act; and related FDA 

regulations. As discussed in the 

guidance document, the specific type 

and amount of data needed to support 

an EUA will vary depending on the 

nature of the declared emergency and 

the nature of the candidate product. The 

guidance document encourages early 

engagement with FDA, explains 

mechanisms for communication, and 

makes content and format 

recommendations on submitting 

information to the Agency. The 

guidance document also recommends 

that a request for consideration for an 

EUA include scientific evidence 

evaluating the product’s safety and 

effectiveness, including the adverse 

event profile for diagnosis, treatment, or 

prevention of the serious or lifethreatening disease or condition, as well 

as data and other information on safety, 

effectiveness, risks and benefits, and (to 

the extent available) alternatives. 

In the Federal Register of March 3, 

2022 (87 FR 12175), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Two comments were 

received. One comment communicated 

that the information collection has 

proven useful in expediting the 

availability of vaccines during the 

pandemic, and also suggested potential 

modifications. The second comment 

was not responsive to the information 

collection topics solicited in our 60-day 

notice. Neither comment offered 

alternative burden estimates. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Requests for a substantive amendment to an existing EUA 2724 2 5448 45 245,160 

Pre-EUA submissions or amendments ................................ 2001 1 2001 34 68,034 

Submitting information required under conditions of authorization ......................................................................... 36 3 108 8 864 

State and local public health authority submissions required under conditions of authorization for unapproved 

EUA product ..................................................................... 1 1 1 2 2 

State and local public health authority requests for Emergency Dispensing Order ................................................... 1 1 1 2 2 

State and local public health authority requests for expiration date extension ........................................................... 1 1 1 20 20 

Total .............................................................................. ........................ ........................ 7560 ........................ 314,082 

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

Although we have averaged burden 

across all respondents, we categorize 

reporting activity by the type of EUArelated submission: (1) those who file a 

request for FDA to issue an EUA and/ 

or a substantive amendment to an EUA 

that has previously been issued; (2) 

those who submit a request for FDA to 

review information/data (i.e., a pre-EUA 

package) for a candidate EUA product or 

a substantive amendment to an existing 

pre-EUA package for preparedness 

purposes; (3) those who must report on 

activities related to an unapproved EUA 

product (e.g., administering product, 

disseminating information) who must 

report to FDA regarding such activity; 

(4) public health authorities (e.g., State, 

local) who must report on certain 

activities (e.g., administering product, 

disseminating information) related to an 

unapproved EUA, and public health 

authorities who submit an expiration 

date extension request for an approved 

product; (5) those who request an 

emergency dispensing order under 

section 564A; and (6) those who request 


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40254 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

expiry dating extensions under section 

564A of the FDC&C Act. We attribute 

greater burden to those requests for FDA 

to review pre-EUA packages submitted 

by product sponsors than burden we 

attribute to those submitted by Federal 

agencies (e.g., Centers for Disease 

Control and Prevention, the Department 

of Defense), and have considered other 

factors that contribute to variability in 

burden for reporting, including the type 

of product and whether there is a 

previously reviewed pre-EUA package 

or investigational application. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Records associated with conditions of authorization Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

EUA Holders ........................................................................ 648 2 1,296 25 32,400 

State and local Public Health Authorities ............................ 1 1 1 3 3 

Total .............................................................................. ........................ ........................ 1,297 ........................ 32,403 

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

We provide a conservative estimate 

for respondent recordkeeping, 

recognizing that the Federal 

Government performs much of this 

activity in conjunction with 

submissions. We do not include burden 

for public health authorities who may 

need to submit emergency dispensing 

orders or expiration date extension 

requests, assuming covered entities 

already maintain these records for the 

products they stockpile. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Information collection activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Dissemination of required information by EUA Holder or 

Authorized Stakeholder .................................................... 635 2 1270 5 6350 

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

Our third-party disclosure estimate is 

based on the number of EUA holders 

and authorized stakeholders 

disseminating information, including 

fact sheets, advertising, and promotional 

materials. 

We have increased our burden 

estimate for the information collection 

to reflect the increase in submissions we 

have received over the last 3 years. 

Dated: June 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14347 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1956] 

Identifying Trading Partners Under the 

Drug Supply Chain Security Act; 

Revised Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

draft guidance for industry entitled 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act.’’ FDA 

is issuing this guidance to assist 

industry and State and local 

governments in understanding how to 

categorize the entities in the drug 

supply chain in accordance with the 

Drug Supply Chain Security Act 

(DSCSA). The revised draft guidance 

explains how to determine when certain 

statutory requirements will apply to 

entities that are considered trading 

partners in the drug supply chain. It 

also discusses the activities of privatelabel distributors, salvagers, and returns 

processors and reverse logistics 

providers. Additionally, the revised 

draft guidance discusses the distribution 

of drugs for emergency medical reasons, 

office use, non-human research 

purposes, and research purposes in 

humans under an investigational new 

drug application. This guidance revises 

the August 2017 draft guidance entitled 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 6, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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. 

• 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’’). 


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