28854 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 

under the user fee provisions of the 

FD&C Act and the procedures for 

submitting requests for waivers, 

reductions, refunds, and requests for 

reconsiderations or appeals. The revised 

draft guidance also provides additional 

clarification on certain issues such as 

user fee exemptions for orphan drugs 

and FDA’s current thinking on 

considerations relevant to eligibility for 

user fee waivers, reductions, and 

refunds under the applicable statutory 

provisions. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Prescription Drug User Fee Waivers, 

Reductions, and Refunds for Drug and 

Biological Products.’’ 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 

draft guidance is not subject to 

Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(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. 

The information collection of this 

draft guidance has been submitted for 

OMB renewal of approval under OMB 

control number 0910–0693. In addition, 

the collection of information associated 

with Form FDA 3397 has been 

previously approved under OMB 

control number 0910–0297. Collection 

of information associated with new drug 

application or biologics license 

applications have been previously 

approved under OMB control numbers 

0910–0001 and 0910–0338, respectively. 

See section X of the draft guidance 

document. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: June 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13295 Filed 6–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2014–D–2138] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Adverse Event Reporting for 

Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act 

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 adverse event 

reporting for outsourcing facilities 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 20, 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 August 20, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of August 20, 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 

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 2014– 

D–2138 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry: Adverse Event Reporting 

for Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act.’’ 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28855 

1Available at: https://www.fda.gov/downloads/ 

Drugs/GuidanceComplianceRegulatoryInformation/ 

Guidances/UCM434188.pdf. 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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 

comments 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. 

Guidance for Industry: Adverse Event 

Reporting for Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act 

OMB Control Number 0910–0800— 

Extension 

This information collection supports 

Agency implementation of the Drug 

Quality and Security Act (DQSA) (Pub. 

L. 113–54), which amended the FD&C 

Act by adding new section 503B (21 

U.S.C. 353b). 

This notice solicits comments on 

adverse event reporting for outsourcing 

facilities under section 503B of the 

FD&C Act. 

Under section 503B(b), a compounder 

can register as an outsourcing facility 

with FDA. If the conditions outlined in 

section 503B(a) of the FD&C Act are 

satisfied, a drug compounded by or 

under the direct supervision of a 

licensed pharmacist in an outsourcing 

facility is exempt from certain sections 

of the FD&C Act, including section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use) and section 

505 (21 U.S.C. 355) (concerning the 

approval of human drug products under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). Drugs compounded in 

outsourcing facilities are not exempt 

from the requirements of section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice for drugs). 

Under section 503B(b)(5), an 

outsourcing facility must submit 

adverse event reports to FDA in 

accordance with the content and format 

requirements established through 

guidance or regulation under 21 CFR 

310.305 (or any successor regulations). 

Accordingly, we developed the 

document, ‘‘Guidance for Industry: 

Adverse Event Reporting for 

Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act’’.1 The guidance explains 

electronic reporting of adverse events in 

accordance with § 310.305 with respect 

to outsourcing facilities. 

Under § 310.305(c)(1), manufacturers, 

packers, and distributors of marketed 

prescription drug products that are not 

the subject of an approved NDA or 

ANDA, including, as set forth in the 

guidance, outsourcing facilities must 

submit to FDA adverse event reports 

within 15 calendar days of receiving the 

information and must submit follow-up 

reports within 15 calendar days of 

receipt of new information about the 

adverse event, or as requested by FDA. 

Outsourcing facilities must submit the 

adverse event report in an electronic 

format that FDA can process, review, 

and archive (collection of information is 

approved by OMB control number 

0910–0291). A copy of the current 

labeling of the compounded drug 

product must be provided. 

Under § 310.305(g), entities subject to 

the regulation must maintain for 10 

years the records of all adverse events 

required to be reported under § 310.305. 

The outsourcing facility should also 

maintain records of its efforts to obtain 

the data elements described in the draft 

guidance for each adverse event report. 

We estimate the burden of the 

information collection as follows: 


amozie on DSK3GDR082PROD with NOTICES1
28856 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Compounding outsourcing facility Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of adverse event reports including copy of labeling and other information as described in the guidance .................................................................................. 55 1 55 1.1 61 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Records of adverse events, including records of efforts to 

obtain the data elements for each adverse event report 55 1 55 16 880 

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

This is the first extension of the 

information collection and we have 

retained the currently approved burden 

estimate. Based on our review of Agency 

data, we estimate that annually 55 

outsourcing facilities (‘‘Number of 

Respondents’’ and ‘‘Total Annual 

Responses’’ in table 1) will submit 

adverse event reports to FDA as 

specified in the guidance and that 

preparing and submitting this 

information will take approximately 1.1 

hours per registrant (‘‘Average Burden 

per Response’’ in table 1). Likewise, we 

estimate that annually 55 outsourcing 

facilities (‘‘Number of Recordkeepers’’ 

in table 2) will maintain records of 

adverse events as specified in the 

guidance and that preparing and 

maintaining the records will take 

approximately 16 hours per registrant 

(‘‘Average Burden per Recordkeeping’’ 

in table 2). 

Dated: June 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13294 Filed 6–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2194] 

Novartis Pharmaceuticals Corporation, 

et al.; Withdrawal of Approval of Five 

New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of five new drug 

applications (NDAs) 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 July 

23, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6248, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

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 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 

NDA 020831 ...... Foradil Aerolizer (formoterol fumarate) Powder, 0.012 milligram (mg)/inhalation.Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936. 

NDA 022504 ...... Axiron (testosterone) Transdermal Metered Solution, 30 mg/ 

1.5 milliliter (mL) actuation.

Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 

46285. 

NDA 050585 ...... Rocephin (ceftriaxone sodium) for Injection, equivalent to 

(EQ) 10 gram (g) base/vial, EQ 250 mg base/vial (IV/IM), 

EQ 500 mg base/vial (IV/IM), EQ 1 g base/vial (IV/IM), EQ 

2 g base/vial (IV/IM), EQ 500 mg base/vial, N/A; N/A, 1% 

(Rocephin kit), EQ 1 g base/vial, N/A; N/A, 1% (Rocephin 

kit).

Hoffmann-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way, 

South San Francisco, CA 94080. 

NDA 050624 ...... Rocephin (ceftriaxone sodium) with Dextrose in Plastic Container Injection, EQ 10 mg base/mL, EQ 20 mg base/mL, 

and EQ 40 mg base/mL.

Do. 

NDA 202763 ...... Testosterone Gel, 25 mg/2.5 g packet, 50 mg/5 g packet ...... ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 

56623. 


amozie on DSK3GDR082PROD with NOTICES1