34020 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated July 14, 2020, FDA 

advised the USPTO that this human 

biological product had undergone a 

regulatory review period and that the 

approval of Smallpox and Monkeypox 

Vaccine, Live 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 

Smallpox and Monkeypox Vaccine, Live 

is 5,650 days. Of this time, 5,315 days 

occurred during the testing phase of the 

regulatory review period, while 335 

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 7, 2004. The 

applicant claims March 8, 2004, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was April 7, 2004, 

which was 30 days after FDA receipt of 

the IND. 

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): October 25, 2018. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

Smallpox and Monkeypox Vaccine, Live 

(BLA 125678) was initially submitted on 

October 25, 2018. 

3. The date the application was 

approved: September 24, 2019. FDA has 

verified the applicant’s claim that BLA 

125678 was approved on September 24, 

2019. 

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 1,825 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 22, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13686 Filed 6–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2099] 

Sponsor Responsibilities—Safety 

Reporting Requirements and Safety 

Assessment for Investigational New 

Drug Application and Bioavailability/ 

Bioequivalence Studies; 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 draft 

guidance for industry entitled ‘‘Sponsor 

Responsibilities—Safety Reporting 

Requirements and Safety Assessment for 

Investigational New Drug Application 

and Bioavailability/Bioequivalence 

Studies.’’ The draft guidance provides 

recommendations for sponsors and 

sponsor-investigators to comply with 

the requirements of investigational new 

drug application (IND) safety reporting 

and safety reporting for bioavailability 

(BA) and bioequivalence (BE) studies. In 

doing so, the guidance provides 

recommendations related to the two IND 

safety reporting provisions that require 

assessment of aggregate data to facilitate 

appropriate IND safety reporting 

practices. An earlier draft guidance for 

industry entitled ‘‘Safety Assessment for 

IND Safety Reporting’’ (December 2015) 

(the 2015 draft guidance) has been 

incorporated into this draft guidance. 

However, this content was revised to 

address feedback from stakeholders and 

comments received on the 2015 draft 

guidance. Concurrent with the 

publication of this draft guidance, we 

are withdrawing the 2015 draft 

guidance. Additionally, this draft 

guidance incorporates content from the 

final guidance for industry and 

investigators entitled ‘‘Safety Reporting 

Requirements for INDs and BA/BE 

Studies’’ (December 2012) (the 2012 

final guidance). This incorporated 

content remains largely unchanged in 

this draft guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 27, 2021 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’’). 

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. 


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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 34021 

• 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– 

2020–D–2099 for ‘‘Sponsor 

Responsibilities—Safety Reporting 

Requirements and Safety Assessment for 

Investigational New Drug Application 

and Bioavailability/Bioequivalence 

Studies.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gouge, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6328, Silver Spring, 

MD 20993–0002, CDEROMP@

fda.hhs.gov; or Stephen Ripley, 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: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Sponsor Responsibilities—Safety 

Reporting Requirements and Safety 

Assessment for Investigational New 

Drug Application and Bioavailability/ 

Bioequivalence Studies.’’ The draft 

guidance provides recommendations for 

sponsors and sponsor-investigators to 

facilitate compliance with the 

requirements of IND safety reporting 

and safety reporting for BA and BE 

studies under §§ 312.32 and 

320.31(d)(3) (21 CFR 312.32 and 

320.31(d)(3)). In doing so, the draft 

guidance provides recommendations for 

sponsors related to the two IND safety 

reporting provisions (§ 312.32(c)(1)(i)(C) 

and (iv)) that require assessment of 

aggregate data to facilitate appropriate 

IND safety reporting practices. More 

generally, it provides sponsors and 

sponsor-investigators recommendations 

regarding expedited safety reporting 

requirements for human drug and 

biological products that are being 

investigated under an IND and for drugs 

that are the subject of BA and BE studies 

that are exempt from the IND 

requirements. 

In the Federal Register of December 

17, 2015 (80 FR 78743), FDA announced 

the availability of the 2015 draft 

guidance entitled ‘‘Safety Assessment 

for IND Safety Reporting.’’ FDA received 

numerous comments on the 2015 draft 

guidance, and these comments were 

carefully considered and addressed by 

FDA in this draft guidance. Noteworthy 

changes include revised 

recommendations on the following: (1) 

Planned unblinding of safety data and 

implications for trial integrity, (2) 

increased flexibility regarding the party 

reviewing safety information across a 

development program for IND safety 

reporting purposes, (3) clarification 

regarding the scope and methodology 

for aggregate analyses, and (4) 

clarification regarding the plan for 

safety surveillance, including what 

elements should be included in the 

plan. Accordingly, concurrent with the 

publication of this draft guidance, we 

are withdrawing the 2015 draft 

guidance. 

Further, this draft guidance 

incorporates content from the 2012 final 

guidance entitled ‘‘Safety Reporting 

Requirements for INDs and BA/BE 

Studies’’. The content from the 2012 

final guidance remains largely 

unchanged in this draft guidance; 

however, this draft guidance does not 

incorporate the investigator provisions 

of the 2012 final guidance. FDA intends 

to publish a separate draft guidance on 

investigator’s responsibilities for safety 

reporting for human drug and biological 

products that are being investigated 

under an IND. 

When this draft guidance and the 

draft guidance on investigator’s 

responsibilities for IND safety reporting 

are finalized, FDA plans to withdraw 

the 2012 final guidance. However, until 

FDA finalizes these two draft guidances, 

the 2012 final guidance remains in 

effect and represents FDA’s current 

thinking. 

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 ‘‘Sponsor Responsibilities—Safety 

Reporting Requirements and Safety 

Assessment for Investigational New 

Drug Application and Bioavailability/ 

Bioequivalence Studies.’’ 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 


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34022 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 

OMB under the PRA. The collections of 

information in 21 CFR parts 312 and 

320 have been approved under OMB 

control number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https:// 

www.fda.gov/regulatory-information/

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 22, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13684 Filed 6–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–E–0029] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; TAZVERIK 

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 TAZVERIK 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 August 27, 2021. 

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 

December 27, 2021. 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. Electronic comments must 

be submitted on or before August 27, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 27, 2021. 

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. 

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– 

2021–E–0029 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; TAZVERIK.’’ 

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 


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