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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices ESTIMATED ANNUALIZED BURDEN HOURSContinued Type of respondent
PHEP Awardees: Major Metropolitan Area Jurisdictions.

Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
FR Doc. 202111872 Filed 6421; 8:45 am BILLING CODE 416318P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020P2317

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Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: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.

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mL, was not withdrawn from sale for reasons of safety or effectiveness.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
khammond on DSKJM1Z7X2PROD with NOTICES

SUMMARY:

VerDate Sep<11>2014

17:36 Jun 04, 2021

Vaccination of critical workforce functional exercise, full-scale exercise, or incident.
Vaccination of critical workforce point of dispensing/dispensing/
vaccination clinic setup.
Vaccination of critical workforce immunization information system.
Five-year distribution FSE OR fiveyear pandemic influenza full-scale exercise.
Facility setup drill
Site activation drill
Staff notification and assembly drill Dispensing throughput drill
Five-year dispensing full-scale exercise or incident.
Five-year dispensing full-scale exercise for each point of dispensing site exercised.

Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 209930002, 301
7963601, Nicole.Mueller@fda.hhs.gov.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 Pub. L. 98417
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 505j7 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.
355j7, 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 drugs 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.

SUPPLEMENTARY INFORMATION:

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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. FDA2020P2317, 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
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