Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20419 

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. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Yu, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–837–7126, email: 

ODAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On May 11, 

2022, the subcommittee will discuss the 

development of a conceptual framework 

that will inform the decision making of 

FDA on sponsor plans and requests for 

waivers of early pediatric investigations 

of molecularly targeted cancer drugs 

and biologics when multiple same-inclass products are approved and/or in 

development, recognizing that the rarity 

of pediatric cancers may preclude the 

feasibility of investigations of multiple 

products. Investigation of more than one 

product may be appropriate when 

specific product characteristics predict 

an improved benefit-risk assessment 

that warrants clinical investigation. 

On May 12, 2022, the subcommittee 

will consider and discuss the potential 

utility and steps to validation of an 

intermediate clinical endpoint, response 

to induction therapy, in the 

development of new drugs for the firstline treatment of patients with high-risk 

neuroblastoma. The European 

Medicines Agency has also been invited 

to present on both days. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. All electronic 

and written submissions submitted to 

the Docket (see ADDRESSES) on or before 

April 27, 2022, will be provided to the 

subcommittee. Oral presentations from 

the public will be scheduled between 

approximately 1:45 p.m. to 2:15 p.m. 

Eastern Time on May 11, 2022. Oral 

presentations from the public will also 

be scheduled between approximately 2 

p.m. to 2:30 p.m. Eastern Time on May 

12, 2022. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before April 19, 2022. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 20, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Joyce Yu (see 

FOR FURTHER INFORMATION CONTACT) at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07378 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–P–1097 and FDA– 

2021–P–1111] 

Determination That PEPCID 

(Famotidine) for Oral Suspension, 40 

Milligrams/5 Milliliters, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that PEPCID 

(famotidine) for oral suspension, 40 

milligrams (mg)/5 milliliters (mL), was 

not withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for PEPCID 

(famotidine) for oral suspension, 40 mg/ 

5 mL, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@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 


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20420 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

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 

approving 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. 

PEPCID (famotidine) for oral 

suspension, 40 mg/5 mL, is the subject 

of NDA 019527, held by Bausch Health 

US, LLC, and initially approved on 

February 2, 1987. PEPCID is indicated 

in adults for the treatment of active 

duodenal ulcer (DU); active gastric 

ulcer; symptomatic nonerosive 

gastroesophageal reflux disease (GERD); 

erosive esophagitis due to GERD, 

diagnosed by biopsy; treatment of 

pathological hypersecretory conditions 

(e.g., Zollinger-Ellison syndrome, 

multiple endocrine neoplasias); and 

reduction of the risk of DU recurrence. 

PEPCID is indicated in pediatric 

patients 1 year of age and older for the 

treatment of peptic ulcer, and GERD 

with or without esophagitis and 

ulcerations. PEPCID is indicated in 

pediatric patients from birth to less than 

1 year of age for the treatment of GERD. 

In a letter received on January 11, 

2019, the applicant notified FDA that 

PEPCID (famotidine) for oral 

suspension, 40 mg/5 mL, was being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Ajanta Pharma USA Inc., submitted a 

citizen petition dated October 11, 2021 

(Docket No. FDA–2021–P–1097), and 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated 

October 13, 2021 (Docket No. FDA– 

2021–P–1111), both under 21 CFR 

10.30, requesting that the Agency 

determine whether PEPCID (famotidine) 

for oral suspension, 40 mg/5 mL, was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petitions 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that PEPCID (famotidine) for 

oral suspension, 40 mg/5 mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioners have 

identified no data or other information 

suggesting that PEPCID (famotidine) for 

oral suspension, 40 mg/5 mL, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of PEPCID 

(famotidine) for oral suspension, 40 mg/ 

5 mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PEPCID (famotidine) for 

oral suspension, 40 mg/5 mL, 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 PEPCID (famotidine) for oral 

suspension, 40 mg/5 mL, 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: March 31, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07391 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0242] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practices for Positron 

Emission Tomography Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on collection of 

information under FDA’s current good 

manufacturing practice (CGMP) 

regulations for positron emission 

tomography (PET) drugs. PET is a 

medical imaging modality involving the 

use of a unique type of 

radiopharmaceutical drug product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 6, 2022. 

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 June 6, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 6, 2022. 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 


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