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withdrawn from sale for reasons of 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were not withdrawn for reasons of 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products were withdrawn for reasons of 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
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42901 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2005–N–0101 for ‘‘Prescription Drug 

User Fee Cover Sheet; Form FDA 3397.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comment on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Prescription Drug User Fee Cover 

Sheet; Form FDA 3397 

OMB Control Number 0910–0297— 

Extension 

Under the prescription drug user fee 

provisions of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (sections 

735 and 736 (21 U.S.C. 379g and 379h)), 

as amended, FDA has the authority to 

assess and collect user fees for certain 

drug and biologics license applications 

(BLAs). Under this authority, 

pharmaceutical companies pay a fee for 

certain new human drug applications 

(NDAs) and BLAs submitted to the 

Agency for review. Because the 

submission of prescription drug user 

fees concurrently with applications is 

required, review of an application by 

FDA cannot begin until the fee is 

submitted. The Prescription Drug User 

Fee Cover Sheet, Form FDA 3397, is 

designed to provide the minimum 

necessary information to determine 

whether a fee is required for review of 

an application, to determine the amount 

of the fee required, and to account for 

and track user fees. The form provides 

a cross-reference of the fee submitted for 

an application by using a unique 

number tracking system. The 

information collected is used by FDA’s 

Center for Drug Evaluation and Research 

(CDER) and Center for Biologics 

Evaluation and Research (CBER) to 

initiate the administrative screening of 

NDAs and BLAs. 

Respondents to this collection of 

information are drug and biologics 

manufacturers that submit NDAs and 

BLAs. Based on FDA’s database system 

for fiscal year (FY) 2017, there are an 

estimated 155 manufacturers of 

products subject to the Prescription 

Drug User Fee Act (Pub. L. 105–115), as 

amended by the Food and Drug 

Administration Reauthorization Act of 

2017 (Pub. L. 115–52.) 

The total number of annual responses 

is based on the number of application 

submissions received by FDA in FY 

2017. CDER received 250 annual 

responses that included the following 

submissions: 218 NDAs and 32 BLAs. 

CBER received 12 BLAs. The estimated 

hours per response are based on past 

FDA experience with the various 

submissions. 

FDA estimates the burden of this 

collection of information as follows: 


daltland on DSKBBV9HB2PROD with NOTICES
42902 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

3397 ............... 155 1.6903 262 0.5 (30 minutes) .................................................................. 131 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 1,724 hours and a 

corresponding decrease of 3,448 

responses. We attribute this program 

change to the restructuring of the 

Prescription Drug Use Fee Program fees. 

The FD&C Act, as amended by the 

Prescription Drug User Fee 

Amendments of 2017 (PDUFA VI), 

authorizes FDA to collect application 

fees for certain applications for the 

review of human drug and biological 

products and discontinued the 

supplement fee. This resulted in the 

removal of supplements from the 

Prescription Drug User Fee Cover Sheet, 

therefore reducing the burden for this 

collection of information. 

Dated: August 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18307 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–2018–D–3092] 

Hematologic Malignancy and 

Oncologic Disease: Considerations for 

Use of Placebos and Blinding in 

Randomized Controlled Clinical Trials 

for Drug Product Development; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Hematologic Malignancy and 

Oncologic Disease: Considerations for 

Use of Placebos and Blinding in 

Randomized Controlled Clinical Trials 

for Drug Product Development.’’ This 

draft guidance provides 

recommendations to industry regarding 

the use of placebos and blinding in 

randomized controlled clinical trials in 

development programs for drug or 

biological products for the treatment of 

hematologic malignancies and oncologic 

diseases regulated by the Center for 

Drug Evaluation and Research (CDER) 

and the Center for Biologics Evaluation 

and Research (CBER). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 23, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–3092 for Hematologic 

Malignancy and Oncologic Disease: 

Considerations for Use of Placebos and 

Blinding in Randomized Controlled 

Clinical Trials for Drug Product 

Development. Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

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.gpo.gov/ 

fdsys/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 


daltland on DSKBBV9HB2PROD with NOTICES