Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices 2617 

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 

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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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) tablet, 20 mg and 

40 mg, is the subject of NDA 019462, 

held by Valeant Pharmaceuticals North 

America LLC, and initially approved on 

October 15, 1986. PEPCID is indicated 

in adult and pediatric patients 40 

kilograms and greater 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. PEPCID is 

indicated in adults for the treatment of 

pathological hypersecretory conditions 

(e.g., Zollinger-Ellison syndrome, 

multiple endocrine neoplasias) and 

reduction of the risk of DU recurrence. 

PEPCID (famotidine) tablet, 20 mg and 

40 mg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Zydus Pharmaceuticals (USA) Inc. 

submitted a citizen petition dated 

August 3, 2021 (Docket No. FDA–2021– 

P–0885), under 21 CFR 10.30, 

requesting that the Agency determine 

whether PEPCID (famotidine) tablet, 20 

mg and 40 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 PEPCID (famotidine) 

tablet, 20 mg and 40 mg, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that PEPCID (famotidine) 

tablet, 20 mg and 40 mg, was withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

PEPCID (famotidine) tablet, 20 mg and 

40 mg, 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) 

tablet, 20 mg and 40 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. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also 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: January 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00832 Filed 1–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0007] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before February 17, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Raborn joseph.raborn@hhs.gov 

or (202) 870–2037. When submitting 

comments or requesting information, 

please include the document identifier 

4040–0007–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Assurances for 

Non-Construction Programs (SF–424B). 

Type of Collection: Renewal. 

OMB No.: 4040–0007. 

Abstract: Assurances for NonConstruction Programs (SF–424B) is 

used by applicants to apply for Federal 

financial assistance. The Assurances for 

Non-Construction Programs (SF–424B) 

form requests that the applicants certify 

specified required assurances as part of 

their grant proposals. This form is 

evaluated by Federal agencies as part of 

the overall grant application. This IC 

expires on February 28, 2022. 


khammond on DSKJM1Z7X2PROD with NOTICES
2618 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices 

Grants.gov seeks a three-year clearance 

of these collections. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Grant Applicant ................................................................................................ 1 9,772 0.5 4,886 

Total .......................................................................................................... 1 9,772 0.5 4,886 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–00760 Filed 1–14–22; 8:45 am] 

BILLING CODE 4151–AE–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0009] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before February 17, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Raborn, joseph.raborn@hhs.gov 

or (202) 870–2037. When submitting 

comments or requesting information, 

please include the document identifier 

4040–0009–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Assurances for 

Construction Programs. 

Type of Collection: Renewal. 

OMB No.: 4040–0009. 

Abstract: Assurances for Construction 

Programs (SF–424D) is used by 

applicants to apply for Federal financial 

assistance. The Assurances for 

Construction Programs (SF–424D) form 

allows the applicants to provide specific 

assurances as part of their grant 

proposals. This form is evaluated by 

Federal agencies as part of the overall 

grant application. This IC expires on 

February 28, 2022. Grants.gov seeks a 

three-year clearance of these collections. 

Type of respondent: Grant Applicant 

and Awardee. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Grant-seeking organizations ............................................................................ 353 1 .5 176.5 

Total .......................................................................................................... 353 1 .5 176.5 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–00761 Filed 1–14–22; 8:45 am] 

BILLING CODE 4151–AE–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0006] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before February 17, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: Joe 

Raborn, joseph.raborn@hhs.gov or (202) 

870–2037. When submitting comments 

or requesting information, please 

include the document identifier 4040– 

0006–30D and project title for reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 


khammond on DSKJM1Z7X2PROD with NOTICES