Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88625 

FDA provided recommendations on 

master protocols for COVID–19 drug 

and biological products in the guidance 

entitled ‘‘COVID–19: Master Protocols 

Evaluating Drugs and Biological 

Products for Treatment or Prevention,’’ 

which posted May 2021 and was 

announced in the Federal Register on 

June 24, 2021 (86 FR 33309) (hereafter 

‘‘2021 COVID–19 Master Protocols 

Guidance’’). FDA issued the guidance to 

communicate its policy for the duration 

of the COVID–19 public health 

emergency (PHE) declared by the 

Secretary of Health and Human Services 

(HHS) on January 31, 2020, including 

any renewals made by the HHS 

Secretary in accordance with section 

319(a)(2) of the Public Health Service 

Act (42 U.S.C. 247d(a)(2)). Furthermore, 

in the Federal Register of March 13, 

2023 (88 FR 15417), FDA listed the 

guidance documents that will no longer 

be effective with the expiration of the 

PHE declaration, guidances that FDA 

was revising to continue in effect for 

180 days after the expiration of the PHE 

declaration to provide a period for 

stakeholder transition and then would 

no longer be in effect, and guidances 

that FDA was revising to continue in 

effect for 180 days after the expiration 

of the PHE declaration during which 

time FDA planned to further revise the 

guidances. The 2021 COVID–19 Master 

Protocols Guidance is included in the 

latter category. The 2021 COVID–19 

Master Protocols Guidance was revised 

to remain in effect for 180 days post 

expiration of the PHE declaration, and 

then revised again to remain in effect 

until March 7, 2024, so that FDA could 

further revise the 2021 guidance. 

FDA is issuing this draft guidance 

because many of the issues addressed in 

the 2021 guidance arise outside the 

context of the COVID–19 PHE. The 

recommendations in this draft guidance 

apply to a range of therapeutic areas, not 

just COVID–19. The draft guidance also 

provides a more comprehensive 

discussion of many of the design and 

analysis topics covered in the 2021 

COVID–19 Master Protocols Guidance. 

For example, the draft guidance 

provides more detailed considerations 

related to randomization, the choice of 

control group, informed consent, 

blinding to treatment assignment, 

adaptive design, multiplicity, 

comparisons between drugs, and the 

evaluation of drug safety. The draft 

guidance also expands on 

considerations for trial oversight, data 

sharing, dissemination of information, 

and submissions to support regulatory 

review. The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on the use of master 

protocols in drug and biological product 

development. 

FDA is issuing this guidance to 

satisfy, in part, a mandate under section 

3607(b)(2)(C–F) of the Food and Drug 

Omnibus Reform Act of 2022 (FDORA). 

Consistent with the FDORA mandate, 

this guidance discusses 

recommendations for clinical trials to 

streamline logistics and facilitate the 

efficient collection and analysis of data, 

as well as important principles for the 

evaluation of effectiveness, 

recommendations for communication 

between sponsors and FDA, and 

considerations related to ensuring 

participant safety and data integrity in 

such trials. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Master Protocols for Drug and 

Biological Product Development.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

FDA is also announcing that the 2021 

COVID–19 Master Protocols Guidance 

will be withdrawn upon publication of 

this draft guidance. FDA has determined 

that the 2021 COVID–19 Master 

Protocols Guidance is no longer needed 

because this new draft is available and 

its recommendations, when finalized, 

will be applicable outside the context of 

the COVID–19 PHE. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 312 for the 

submission of investigational new drug 

applications (INDs), including 

protocols, protocol amendments, and 

information amendments, have been 

approved under OMB control number 

0910–0014. The information collections 

for new drug application (NDA) 

regulations (including abbreviated new 

drug applications (ANDAs)) (21 CFR 

part 314) and related guidances are 

approved under OMB control number 

0910–0001, and our biological licensing 

applications (BLA) regulations (21 CFR 

part 601) are approved under OMB 

control number 0910–0338. The 

collections of information in 21 CFR 

parts 50 and 56 for the protection of 

human subjects and institutional review 

boards have been approved under OMB 

control number 0910–0130. The 

collections of information related to the 

protection of human subjects under 45 

CFR part 46 and to IRB recordkeeping 

under 45 CFR 46.115 have been 

approved under OMB control number 

0990–0260. The collections of 

information in 21 CFR part 11, 

Electronic Records; Electronic 

Signatures, have been approved under 

OMB control number 0910–0303. The 

information collection requirements in 

FDA’s guidance for industry entitled 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581. The 

information collection requirements in 

FDA’s guidance for industry entitled 

‘‘Oversight of Clinical Investigations—A 

Risk-Based Approach to Monitoring’’ 

and FDA’s final guidance for industry 

entitled ‘‘A Risk-Based Approach to 

Monitoring of Clinical Investigations’’ 

have been approved under OMB control 

number 0910–0733. The information 

collections in FDA’s guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ have been approved under 

OMB control number 0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28210 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–E–3017] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Emgality 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


ddrumheller on DSK120RN23PROD with NOTICES1
88626 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Emgality and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by February 20, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 20, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 

February 20, 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– 

2019–E–3017 ‘‘For Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; EMGALITY.’’ 

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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biological product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 Emgality 

(galcanezumab-gnlm). Emgality is 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88627 

indicated for the preventive treatment of 

migraine in adults. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

Emgality (U.S. Patent No. 9,505,838) 

from Eli Lilly and Company, and the 

USPTO requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 24, 2020, FDA advised the 

USPTO that this human biological 

product had undergone a regulatory 

review period and that the approval of 

Emgality 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 

Emgality is 2,738 days. Of this time, 

2,372 days occurred during the testing 

phase of the regulatory review period, 

while 366 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: April 1, 2011. FDA 

has verified the applicant’s claim that 

the date the investigational new drug 

application became effective was on 

April 1, 2011. 

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): September 27, 2017. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for Emgality (BLA B761063) was 

initially submitted on September 27, 

2017. 

3. The date the application was 

approved: September 27, 2018. FDA has 

verified the applicant’s claim that BLA 

B761063 was approved on September 

27, 2018. 

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 application for patent extension, 

this applicant seeks 403 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: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28233 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–E–3287] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Copiktra 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Copiktra and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by February 20, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 20, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 

February 20, 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– 

2019–E–3287 for ‘‘Determination of 


ddrumheller on DSK120RN23PROD with NOTICES1