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25. Osmanov, A. and D.W. Denning, ‘‘Burden 

of Serious Fungal Infections in Ukraine,’’ 

Mycoses, 58(Suppl 5): 94–100, October 

2015. 

26. Morrow, B.M., N.Y. Hsaio, M. Zampoli, 

et al., ‘‘Pneumocystis Pneumonia in 

South African Children with and 

Without Human Immunodeficiency 

Virus Infection in the Era of Highly 

Active Antiretroviral Therapy,’’ The 

Pediatric Infectious Disease Journal, 

29(6):535–539, June 2010. 

27. Stansell, J.D., D.H. Osmond, E. 

Charlebois, E., et al., ‘‘Predictors of 

Pneumocystis carinii Pneumonia in HIVInfected Persons. Pulmonary 

Complications of HIV Infection Study 

Group,’’ American Journal of Respiratory 

and Critical Care Medicine, 155(1):60– 

66, January 1997. 

28. Wasserman, S., M.E. Engel, M. 

Mendelson, ‘‘Burden of Pneumocystis 

Pneumonia in HIV-Infected Adults in 

Sub-Saharan Africa: Protocol for a 

Systematic Review,’’ Systematic 

Reviews, 2:112, December 12, 2013. 

29. Fisk, D.T., S. Meshnick, S., and P.H. 

Kazanjian, ‘‘Pneumocystis carinii 

Pneumonia in Patients in the Developing 

World Who Have Acquired 

Immunodeficiency Syndrome,’’ Clinical 

Infectious Diseases: An Official 

Publication of the Infectious Diseases 

Society of America, 36(1):70–78, January 

1, 2003. 

30. de Boer, M.G., J.W. de Fijter, F.P. Kroon, 

‘‘Outbreaks and Clustering of 

Pneumocystis Pneumonia in Kidney 

Transplant Recipients: A Systematic 

Review,’’ Medical Mycology, 49(7):673– 

680, October 2011. 

31. Sonego, M., M.C. Pellegrin, G. Becker, et 

al., ‘‘Risk Factors for Mortality from 

Acute Lower Respiratory Infections 

(ALRI) in Children under Five Years of 

Age in Low and Middle-Income 

Countries: A Systematic Review and 

Meta-Analysis of Observational Studies,’’ 

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32. Morris, A., J.D. Lundgren, H. Masur, et 

al., ‘‘Current Epidemiology of 

Pneumocystis Pneumonia,’’ Emerging 

Infectious Diseases, 10(10):1713–1720, 

October 2004. 

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‘‘Pneumocystis jirovecii Pneumonia in 

the Non-HIV-Infected Population,’’ The 

Annals of Pharmacotherapy, 50(8):673– 

679, August 2016. 

34. Joint United Nations Programme on HIV/ 

AIDS (UNAIDS), ‘‘Global Report: 

UNAIDS Report on the Global AIDS 

Epidemic 2013,’’ accessed December 9, 

2016, available at http://files.unaids.org/ 

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diseases/en/. 

Dated: August 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18313 Filed 8–23–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2018–P–0964 and FDA– 

2018–P–0967] 

Determination That PLASMA–LYTE M 

AND DEXTROSE 5% and PLASMA 

LYTE 148 AND DEXTROSE 5% 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 PLASMA–LYTE M 

AND DEXTROSE 5% (calcium chloride, 

37 milligrams (mg)/100 milliliters (mL); 

dextrose, 5 grams (g)/100 mL; 

magnesium chloride, 30 mg/100 mL; 

potassium chloride, 119 mg/100 mL; 

sodium acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) and PLASMA LYTE 

148 AND DEXTROSE 

5% (dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 37 mg/100 mL; sodium 

acetate, 368 mg/100 mL; sodium 

chloride, 526 mg/100 mL; sodium 

gluconate, 502 mg/100 mL) 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 

these products as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Heather A. Dorsey, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6219, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

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. 

PLASMA–LYTE M AND DEXTROSE 

5% (calcium chloride, 37 mg/100 mL; 

dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 119 mg/100 mL; sodium 

acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) is the subject of NDA 

017390, held by Baxter Healthcare 

Corp., and initially approved on 

February 1, 1979. PLASMA LYTE 148 

AND DEXTROSE 5% (dextrose, 5 g/100 

mL; magnesium chloride, 30 mg/100 

mL; potassium chloride, 37 mg/100 mL; 

sodium acetate, 368 mg/100 mL; sodium 

chloride, 526 mg/100 mL; sodium 

gluconate, 502 mg/100 mL) is the 

subject of NDA 017451, held by Baxter 

Healthcare Corp., and initially approved 

on February 2, 1979. PLASMA LYTE M 

AND DEXTROSE 5% is indicated as a 

source of water, electrolytes, and 

calories or as an alkalinizing agent. 

PLASMA LYTE 148 AND DEXTROSE 

5% is indicated as a source of water, 

electrolytes, and calories, or as an 

alkalinizing agent. 

PLASMA–LYTE M AND DEXTROSE 

5% (calcium chloride, 37 mg/100 mL; 

dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 119 mg/100 mL; sodium 

acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) and PLASMA LYTE 

148 AND DEXTROSE 


daltland on DSKBBV9HB2PROD with NOTICES
42900 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 

5% (dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 37 mg/100 mL; sodium 

acetate, 368 mg/100 mL; sodium 

chloride, 526 mg/100 mL; sodium 

gluconate, 502 mg/100 mL) are currently 

listed in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. In the Federal Register of October 

13, 2015 (80 FR 61426), FDA announced 

that it was withdrawing approval of 

NDAs 017390 and 017451, effective 

November 12, 2015. 

Fresenius Kabi USA, LLC, submitted 

two citizen petitions dated March 2, 

2018 (Docket No. FDA–2018–P–0964), 

and March 5, 2018 (Docket No. FDA– 

2018–P–0967), under 21 CFR 10.30, 

requesting that the Agency determine 

whether PLASMA–LYTE M AND 

DEXTROSE 5% (calcium chloride, 37 

mg/100 mL; dextrose, 5 g/100 mL; 

magnesium chloride, 30 mg/100 mL; 

potassium chloride, 119 mg/100 mL; 

sodium acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) and PLASMA LYTE 

148 AND DEXTROSE 

5% (dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 37 mg/100 mL; sodium 

acetate, 368 mg/100 mL; sodium 

chloride, 526 mg/100 mL; sodium 

gluconate, 502 mg/100 mL) were 

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 PLASMA–LYTE M AND 

DEXTROSE 

5% (calcium chloride, 37 mg/100 mL; 

dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 119 mg/100 mL; sodium 

acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) and PLASMA LYTE 

148 AND DEXTROSE 5% (dextrose, 5 g/ 

100 mL; magnesium chloride, 30 mg/ 

100 mL; potassium chloride, 37 mg/100 

mL; sodium acetate, 368 mg/100 mL; 

sodium chloride, 526 mg/100 mL; 

sodium gluconate, 502 mg/100 mL) 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that these drug 

products were withdrawn for reasons of 

safety or effectiveness. 

We have carefully reviewed our files 

for records concerning the withdrawal 

of PLASMA–LYTE M AND DEXTROSE 

5% (calcium chloride, 37 mg/100 mL; 

dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 119 mg/100 mL; sodium 

acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) and PLASMA LYTE 

148 AND DEXTROSE 5% (dextrose, 5 g/ 

100 mL; magnesium chloride, 30 mg/ 

100 mL; potassium chloride, 37 mg/100 

mL; sodium acetate, 368 mg/100 mL; 

sodium chloride, 526 mg/100 mL; 

sodium gluconate, 502 mg/100 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 these 

drug products were not withdrawn from 

sale for reasons of safety or 

effectiveness. 

Accordingly, the Agency will 

continue to list PLASMA–LYTE M AND 

DEXTROSE 5% (calcium chloride, 37 

mg/100 mL; dextrose, 5 g/100 mL; 

magnesium chloride, 30 mg/100 mL; 

potassium chloride, 119 mg/100 mL; 

sodium acetate, 161 mg/100 mL; sodium 

chloride, 94 mg/100 mL; sodium lactate, 

138 mg/100 mL) and PLASMA LYTE 

148 AND DEXTROSE 

5% (dextrose, 5 g/100 mL; magnesium 

chloride, 30 mg/100 mL; potassium 

chloride, 37 mg/100 mL; sodium 

acetate, 368 mg/100 mL; sodium 

chloride, 526 mg/100 mL; sodium 

gluconate, 502 mg/100 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 these drug products 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 these drug 

products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: August 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18311 Filed 8–23–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0101] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prescription Drug 

User Fee Cover Sheet; Form FDA 3397 

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 the information 

collection requirements relating to the 

Prescription Drug User Fee Cover Sheet, 

Form FDA 3397, that must be submitted 

along with certain drug and biological 

product applications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 23, 2018. 

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 October 23, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 23, 2018. 

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 

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 

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 


daltland on DSKBBV9HB2PROD with NOTICES