39100 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 

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 biologic 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 TEPEZZA 

(teprotumumab-trbw). TEPEZZA is 

indicated for the treatment of thyroid 

eye disease. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

TEPEZZA (U.S. Patent No. 7,572,897) 

from Hoffman-La Roche Inc., and the 

USPTO requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

April 5, 2021, FDA advised the USPTO 

that this human biological product had 

undergone a regulatory review period 

and that the approval of TEPEZZA 

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 

TEPEZZA is 2,958 days. Of this time, 

2,760 days occurred during the testing 

phase of the regulatory review period, 

while 198 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: December 18, 2011. 

The applicant claims December 19, 

2011, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 18, 

2011, 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): July 8, 2019. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

TEPEZZA (BLA 761143) was initially 

submitted on July 8, 2019. 

3. The date the application was 

approved: January 21, 2020. FDA has 

verified the applicant’s claim that BLA 

761143 was approved on January 21, 

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 application for patent extension, 

this applicant seeks 1,578 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 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13956 Filed 6–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–P–0069] 

Determination That MICRONOR 

(Norethindrone Tablets, 0.35 Milligram) 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that MICRONOR 

(norethindrone tablets, 0.35 milligram 

(mg)) was not withdrawn from sale for 

reasons of safety or effectiveness. This 


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Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 39101 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for norethindrone 

tablets, 0.35 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6280, 

Silver Spring, MD 20993–0002, 301– 

796–3601, Nicole.Mueller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

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

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

FDA’s approval of an ANDA that refers 

to the listed drug (§ 314.161 (21 CFR 

314.161)). FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

MICRONOR (norethindrone tablets, 

0.35 mg) is the subject of NDA 016954, 

held by Janssen Pharmaceuticals Inc. 

(Janssen), and initially approved on 

January 2, 1973. MICRONOR is 

indicated for the prevention of 

pregnancy. 

In a document dated June 6, 2018, 

Janssen notified FDA that the decision 

to withdraw MICRONOR 

(norethindrone tablets, 0.35 mg) from 

sale was based on business reasons and 

not for reasons of safety or efficacy. FDA 

moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Aurobindo Pharma USA, Inc., 

submitted a citizen petition dated 

January 11, 2022 (Docket No. FDA– 

2022–P–0069), under 21 CFR 10.30, 

requesting that the Agency determine 

whether MICRONOR (norethindrone 

tablets, 0.35 mg) was withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that MICRONOR 

(norethindrone tablets, 0.35 mg) was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that MICRONOR 

(norethindrone tablets, 0.35 mg) was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

MICRONOR (norethindrone tablets, 0.35 

mg) from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 

not withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list MICRONOR 

(norethindrone tablets, 0.35 mg) in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to MICRONOR (norethindrone tablets, 

0.35 mg) may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13958 Filed 6–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2455] 

Patient-Focused Drug Development: 

Selecting, Developing, or Modifying 

Fit-for-Purpose Clinical Outcome 

Assessments; Draft Guidance for 

Industry, Food and Drug 

Administration Staff, and Other 

Stakeholders; 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 ‘‘PatientFocused Drug Development: Selecting, 

Developing, or Modifying Fit-forPurpose Clinical Outcome 

Assessments.’’ This guidance (Guidance 

3) is the third in a series of four 

methodological patient-focused drug 

development (PFDD) guidance 

documents that describe how 

stakeholders (patients, researchers, 

medical product developers, and others) 

can collect and submit patient 

experience data and other relevant 

information from patients and 

caregivers to be used for medical 

product development and regulatory 

decision-making. When finalized, 

Guidance 3 will represent the current 

thinking of the Center for Drug 

Evaluation and Research, the Center for 

Biologics Evaluation and Research, and 

the Center for Devices and Radiological 

Health on this topic. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 28, 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 


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