30320 Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hours) 

Vaccination of critical workforce 

(functional exercise, full-scale exercise, or incident).

62 1 12/60 

Vaccination of critical workforce 

(point of dispensing/dispensing/ 

vaccination clinic setup).

62 1 12/60 

Vaccination of critical workforce (immunization information system).62 1 12/60 

Five-year distribution FSE OR fiveyear pandemic influenza full-scale 

exercise.

62 1 0.5 

PHEP Awardees: Major Metropolitan Area Jurisdictions.Facility setup drill .............................

Site activation drill ............................

4 

4 

1 

1 

45/60 

1 

Staff notification and assembly drill 4 1 1 

Dispensing throughput drill .............. 4 1 12/60 

Five-year dispensing full-scale exercise or incident.4 1 6/60 

Five-year dispensing full-scale exercise for each point of dispensing 

site exercised.

4 1 6/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–11872 Filed 6–4–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–P–2317] 

Determination That QUELICIN 

PRESERVATIVE FREE 

(Succinylcholine Chloride) Injection, 20 

Milligrams/Milliliter, 50 Milligrams/ 

Milliliter, and 100 Milligrams/Milliliter, 

Was Not Withdrawn From Sale for 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 or Agency) has 

determined that QUELICIN 

PRESERVATIVE FREE (succinylcholine 

chloride) Injection, 20 milligrams (mg)/ 

milliliter (mL), 50 mg/mL, and 100 mg/ 

mL, was not withdrawn from sale for 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 QUELICIN 

PRESERVATIVE FREE (succinylcholine 

chloride) Injection, 20 mg/mL, 50 mg/ 

mL, and 100 mg/mL, 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: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which 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. 

QUELICIN PRESERVATIVE FREE 

(succinylcholine chloride) Injection, 20 

mg/mL, 50 mg/mL, and 100 mg/mL, is 

the subject of NDA 008845, held by 

Hospira, Inc., and initially approved on 

May 1, 1953. QUELICIN 

PRESERVATIVE FREE is indicated as an 

adjunct to general anesthesia, to 

facilitate tracheal intubation, and to 

provide skeletal muscle relaxation 

during surgery or mechanical 

ventilation. 

Baxter Healthcare Corp. submitted a 

citizen petition dated December 21, 

2020 (Docket No. FDA–2020–P–2317), 

under 21 CFR 10.30, requesting that the 

Agency determine whether QUELICIN 

PRESERVATIVE FREE (succinylcholine 

chloride) Injection, 20 mg/mL, 50 mg/ 

mL, and 100 mg/mL, 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 QUELICIN 

PRESERVATIVE FREE (succinylcholine 

chloride) Injection, 20 mg/mL, 50 mg/ 

mL, and 100 mg/mL, was not 

withdrawn for reasons of safety or 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices 30321 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that QUELICIN 

PRESERVATIVE FREE (succinylcholine 

chloride) Injection, 20 mg/mL, 50 mg/ 

mL, and 100 mg/mL, was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

QUELICIN PRESERVATIVE FREE 

(succinylcholine chloride) Injection, 20 

mg/mL, 50 mg/mL, and 100 mg/mL, 

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 QUELICIN 

PRESERVATIVE FREE (succinylcholine 

chloride) Injection, 20 mg/mL, 50 mg/ 

mL, and 100 mg/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 QUELICIN PRESERVATIVE FREE 

(succinylcholine chloride) Injection, 20 

mg/mL, 50 mg/mL, and 100 mg/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: May 27, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11802 Filed 6–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–P–2174] 

Determination That ATROVENT 

(Ipratropium Bromide) Metered Spray, 

0.021 Micrograms/Spray and 0.042 

Micrograms/Spray, Were 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 or Agency) has 

determined that ATROVENT 

(ipratropium bromide) metered spray, 

0.021 micrograms (mcg)/spray and 0.042 

mcg/spray, were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

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: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which 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. 

ATROVENT (ipratropium bromide) 

metered spray, 0.021 mcg/spray, is the 

subject of NDA 020393 and ATROVENT 

(ipratropium bromide) metered spray, 

0.042 mcg/spray, is the subject of NDA 

020394, both held by Boehringer 

Ingelheim Pharmaceuticals, Inc., and 

initially approved on October 20, 1995. 

ATROVENT is indicated for the 

symptomatic relief of rhinorrhea 

associated with allergic and nonallergic 

perennial rhinitis in adults and children 

age 6 years and older. 

In letters dated December 22, 2017, 

Boehringer Ingelheim Pharmaceuticals, 

Inc., requested withdrawal of NDA 

020393 and NDA 020394 for 

ATROVENT (ipratropium bromide). In 

the Federal Register of July 12, 2018 (83 

FR 32305), FDA announced that it was 

withdrawing approval of NDA 020393 

and NDA 020394, effective August 13, 

2018. 

Lachman Consulting Services, Inc., 

submitted a citizen petition dated 

November 5, 2020 (Docket No. FDA– 

2020–P–2174), under 21 CFR 10.30, 

requesting that the Agency determine 

whether ATROVENT (ipratropium 

bromide) metered spray, 0.021 mcg/ 

spray and 0.042 mcg/spray, were 

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 ATROVENT (ipratropium 

bromide) metered spray, 0.021 mcg/ 

spray and 0.042 mcg/spray, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that ATROVENT 

(ipratropium bromide) metered spray, 

0.021 mcg/spray and 0.042 mcg/spray, 

were withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

ATROVENT (ipratropium bromide) 

metered spray, 0.021 mcg/spray and 

0.042 mcg/spray, 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 these drug products were 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ATROVENT 

(ipratropium bromide) metered spray, 

0.021 mcg/spray and 0.042 mcg/spray, 

in the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 


khammond on DSKJM1Z7X2PROD with NOTICES