Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35653 

Cover Sheet and generating the user fee 

ID number. 

The user fee ID number must be 

included on the check, bank draft, or 

postal money order and must be made 

payable to the order of the Food and 

Drug Administration. Payments can be 

mailed to: Food and Drug 

Administration, P.O. Box 979108, St. 

Louis, MO 63197–9000. If checks are to 

be sent by a courier that requests a street 

address, the courier can deliver checks 

to: U.S. Bank, Attention: Government 

Lockbox 979108, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. For questions concerning courier 

delivery, U.S. Bank can be contacted at 

314–418–4013. This telephone number 

is only for questions about courier 

delivery.) The FDA post office box 

number (P.O. Box 979108) must be 

written on the check, bank draft, or 

postal money order. 

For payments made by wire transfer, 

the unique user fee ID number must be 

referenced. Without the unique user fee 

ID number, the payment may not be 

applied. If the payment amount is not 

applied, the invoice amount will be 

referred to collections. The originating 

financial institution may charge a wire 

transfer fee. Applicable wire transfer 

fees must be included with payment to 

ensure fees are fully paid. Questions 

about wire transfer fees should be 

addressed to the financial institution. 

The following account information 

should be used to send payments by 

wire transfer: U.S. Department of 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, account number: 

75060099, routing number: 021030004, 

SWIFT: FRNYUS33. FDA’s tax 

identification number is 53–0196965. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16067 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2456] 

Slowly Progressive, Low-Prevalence 

Rare Diseases With Substrate 

Deposition That Results From Single 

Enzyme Defects: Providing Evidence 

of Effectiveness for Replacement or 

Corrective Therapies; Draft Guidance 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 ‘‘Slowly 

Progressive, Low-Prevalence Rare 

Diseases with Substrate Deposition That 

Results from Single Enzyme Defects: 

Providing Evidence of Effectiveness for 

Replacement or Corrective Therapies.’’ 

This document is intended to provide 

guidance to sponsors on the evidence 

necessary to demonstrate the 

effectiveness of new drugs, including 

biological drugs, or new drug uses 

intended for slowly progressive, lowprevalence rare diseases that are 

associated with substrate deposition and 

are caused by single enzyme defects. 

This guidance applies only to those lowprevalence rare diseases with a wellcharacterized pathophysiology and in 

which changes in substrate deposition 

can be readily measured in relevant 

tissue(s). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 25, 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–2456 for ‘‘Slowly Progressive, 

Low-Prevalence Rare Diseases with 

Substrate Deposition That Results from 

Single Enzyme Defects: Providing 

Evidence of Effectiveness for 

Replacement or Corrective Therapies; 

Draft Guidance for Industry; 

Availability.’’ 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. 


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35654 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Dragos Roman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5152, 

Silver Spring, MD 20993–0002, 301– 

796–1285; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Slowly Progressive, Low-Prevalence 

Rare Diseases with Substrate Deposition 

That Results from Single Enzyme 

Defects: Providing Evidence of 

Effectiveness for Replacement or 

Corrective Therapies.’’ This document is 

intended to provide guidance to 

sponsors on the evidence necessary to 

demonstrate the effectiveness of new 

drugs or new drug uses intended for 

slowly progressive, low-prevalence rare 

diseases that are associated with 

substrate deposition and are caused by 

single enzyme defects. This guidance 

applies only to those low-prevalence 

rare diseases with a well-characterized 

pathophysiology and in which changes 

in substrate deposition can be readily 

measured in relevant tissue(s). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on providing evidence of effectiveness 

for replacement or corrective therapies 

intended for slowly progressive, lowprevalence rare diseases with substrate 

deposition that results from single 

enzyme defects. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 50 have been 

approved under OMB control number 

0910–0755. The collections of 

information for expedited programs in 

the guidance for industry entitled 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ 

(available at https://www.fda.gov/ucm/ 

groups/fdagov-public/@fdagov-drugsgen/documents/document/ucm35

8301.pdf) have been approved under 

OMB control number 0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or https://

www.regulations.gov. 

Dated: July 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16036 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2493] 

ICU Medical, Inc., et al.; Withdrawal of 

Approval of 31 Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 31 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

August 27, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945, 

Trang.Tran@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in the 

table have informed FDA that these drug 

products are no longer marketed and 

have requested that FDA withdraw 

approval of the applications under the 

process described in § 314.150(c) (21 

CFR 314.150(c)). The applicants have 

also, by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 020345 .... Aminosyn-HF (amino acids) Injection, 8% ............................... ICU Medical, Inc., 600 North Field Dr., Lake Forest, IL 

60045. 

ANDA 040723 .... Isosorbide Dinitrate Extended-Release Tablets USP, 40 milligrams (mg).Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, 

CA 94544. 

ANDA 064062 .... Amphotericin B for Injection USP, 50 mg/vial ......................... Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 

92618. 

ANDA 064200 .... Cefotaxime for Injection USP, Equivalent to (EQ) 500 mg 

base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 


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