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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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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39102 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 

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– 

2018–N–2455 for ‘‘Patient-Focused Drug 

Development: Selecting, Developing, or 

Modifying Fit-for-Purpose Clinical 

Outcome Assessments.’’ 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, or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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: 

Shannon Cole, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6306, 

Silver Spring, MD 20993–0002, 301– 

796–9208, Shannon.Cole@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; or Office of Strategic 

Partnerships and Technology 

Innovation, Center for Devices and 

Radiological Health, cdrh-pro@

fda.hhs.gov, 800–638–2041 or 301–796– 

7100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Patient-Focused Drug Development: 

Selecting, Developing, or Modifying Fitfor-Purpose Clinical Outcome 

Assessments.’’ This guidance (Guidance 

3) is the third in a series of four 

methodological 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. For purposes of this 

guidance a ‘‘medical product’’ refers to 

a drug (as defined in section 201 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 321)) intended for human 

use, a device (as defined in section 201), 

or a biological product (as defined in 

section 351 of the Public Health Service 

Act (42 U.S.C. 262)). 

This series of guidance documents is 

intended to facilitate the advancement 

and use of systematic approaches to 

collect and use robust and meaningful 

input that can more consistently inform 

medical product development and 

regulatory decision-making. Guidance 3 

discusses approaches to selecting, 

modifying, developing, and validating 

clinical outcome assessments to 

measure outcomes of importance to 

patients in clinical 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 ‘‘Patient-Focused Drug Development: 

Selecting, Developing, or Modifying Fitfor-Purpose Clinical Outcome 

Assessments.’’ 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 

OMB under the PRA. This guidance 

refers to collections of information from 

‘‘individuals under treatment or clinical 

examination in connection with 

research,’’ which are not subject to 

review by OMB under 5 CFR 

1320.3(h)(5). Respondents submit to 

FDA collections of information to 

support the medical product’s 


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Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 39103 

effectiveness and to support claims in 

approved medical labeling. 

The collections of information in 21 

CFR 314.50, 314.126, and 601.2 are 

submitted to FDA to support the 

medical product’s effectiveness and to 

support claims in approved medical 

product labeling. The collections of 

information have been approved under 

OMB control numbers 0910–0001 and 

0910–0338. The collections of 

information in 21 CFR 312.23 regarding 

investigational new drug applications, 

including clinical trial design and study 

protocols, have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

parts 50 and 56 regarding institutional 

review boards and the protection of 

human subjects have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR part 11 regarding electronic records 

and signatures have been approved 

under OMB control number 0910–0303. 

The collections of information described 

in FDA’s guidance entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’‘ (https://www.fda.gov/media/ 

109951/download) have been approved 

under OMB control number 0910–0429. 

III. Additional Information 

Section 3002 of Title III, Subtitle A, of 

the 21st Century Cures Act (Pub. L. 114– 

255) directs FDA to develop patientfocused drug development guidance to 

address a number of areas, including 

under section 3002(c)(2): 

Methodological approaches that may be 

used to develop and identify what is 

important to patients with respect to 

burden of disease, burden of treatment, 

and the benefits and risks in the 

management of the patient’s disease. 

In addition, FDA committed to meet 

certain performance goals under the 

sixth authorization of the Prescription 

Drug User Fee Act. These goal 

commitments were developed in 

consultation with patient and consumer 

advocates, healthcare professionals, and 

other public stakeholders, as part of 

negotiations with regulated industry. 

Section J.1 of the commitment letter, 

‘‘Enhancing the Incorporation of the 

Patient’s Voice in Drug Development 

and Decision-Making’’ (https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf) outlines work, 

including the development of a series of 

guidance documents and associated 

public workshops to facilitate the 

advancement and use of systematic 

approaches to collect and use robust 

and meaningful patient and caregiver 

input that can more consistently inform 

drug development, and, as appropriate, 

regulatory decision-making. 

IV. 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: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13952 Filed 6–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

April 1, 2022, through April 30, 2022. 

This list provides the name of 

petitioner, city and state of vaccination 

(if unknown then city and state of 

person or attorney filing claim), and 

case number. In cases where the Court 

has redacted the name of a petitioner 

and/or the case number, the list reflects 

such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that there is 

not a preponderance of the evidence that the 

illness, disability, injury, condition, or death 

described in the petition is due to factors 

unrelated to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, injury, or 

condition not set forth in the Vaccine Injury 

Table but which was caused by’’ one of the 

vaccines referred to in the Table, or 


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