42512 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number 

of respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Format labeling in accordance with § 201.66(c) and (d) for 

new sunscreen SKUs ....................................................... 20 3 60 12 720 

Request for Drug Facts exemption or deferral § 201.66(e) 1 0.125 0.125 24 3 

Total .............................................................................. ........................ ........................ ........................ ........................ 723 

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

We note that these estimates may be 

adjusted in the future development of 

an upcoming rulemaking on over-thecounter sunscreen products (RIN 0910– 

AA01). FDA intends to amend this 

information collection and/or seek 

approval of additional information 

collections, as appropriate, concurrent 

with this rulemaking. 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18073 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2018–P–1335 and FDA– 

2018–P–1361] 

Determination That DITROPAN XL 

(Oxybutynin Chloride) Extended 

Release Tablets, 15 Milligrams, 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Not Withdrawn From Sale for Reasons 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 DITROPAN XL 

(oxybutynin chloride) Extended Release 

Tablets, 15 milligrams (mg), were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for DITROPAN 

XL (oxybutynin chloride) Extended 

Release Tablets, 15 mg, if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: Glen 

Cheng, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6210, Silver Spring, 

MD 20993–0002, 301–796–1494. 

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. 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 5 mg, 10 mg, 

and 15 mg, are the subject of NDA 

020897, held by Janssen 

Pharmaceuticals Inc., and initially 

approved on December 16, 1998. 

DITROPAN XL is indicated for the 

treatment of overactive bladder with 

symptoms of urge urinary incontinence, 

urgency, and frequency, and for the 

treatment of pediatric patients aged 6 

years and older with symptoms of 

detrusor overactivity associated with a 

neurological condition (e.g., spina 

bifida). 

In a letter dated December 14, 2017, 

Janssen Pharmaceuticals Inc. notified 

FDA that DITROPAN XL (oxybutynin 

chloride) Extended Release Tablets, 15 

mg, were being discontinued, and FDA 

moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. Although 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 5 mg and 10 

mg, were also previously listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book, they are 

now listed in the ‘‘Prescription Drug 

Product List’’ section of the Orange 

Book. 

Hyman, Phelps & McNamara, P.C., 

submitted a citizen petition dated 

March 30, 2018 (Docket No. FDA–2018– 

P–1335), and Ajanta Pharma Limited 

submitted a citizen petition dated April 

2, 2018 (Docket No. FDA–2018–P– 

1361), under 21 CFR 10.30, requesting 

that the Agency determine whether 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 5 mg, 10 mg, 

and 15 mg, were withdrawn from sale 

for reasons of safety or effectiveness. 

As noted, DITROPAN XL (oxybutynin 

chloride) Extended Release Tablets, 5 

mg and 10 mg, are no longer listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book, and 

therefore we need not determine 

whether they were withdrawn from sale 

for reasons of safety or effectiveness. 

With regard to DITROPAN XL 

(oxybutynin chloride) Extended Release 

Tablets, 15 mg, 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 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 15 mg, were 

not withdrawn from sale for reasons of 

safety or effectiveness. The petitioners 

have identified no data or other 

information suggesting that this drug 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42513 

product was withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 15 mg, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list DITROPAN XL 

(oxybutynin chloride) Extended Release 

Tablets, 15 mg, 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 DITROPAN XL 

(oxybutynin chloride) Extended Release 

Tablets, 15 mg, 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 this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: August 15, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18045 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2381] 

The Food and Drug Administration’s 

Comprehensive, Multi-Year Nutrition 

Innovation Strategy; Extension of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

notice of a public meeting and request 

for comments, published in the Federal 

Register of June 27, 2018. The notice 

announced a public meeting entitled 

‘‘FDA’s Comprehensive, Multi-Year 

Nutrition Innovation Strategy’’ and 

invited interested parties to provide 

information on specific topics related to 

FDA’s Nutrition Innovation Strategy. 

We are extending the comment period 

to give interested parties more time to 

comment. 

DATES: FDA is extending the comment 

period on the notice and its request for 

comment, published in the Federal 

Register of June 27, 2018 (83 FR 30180). 

Submit either electronic or written 

comments by October 11, 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 11, 

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

electronic filing system will accept 

comments until midnight Eastern Time, 

October 11, 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– 

2018–N–2381 for ‘‘The Food and Drug 

Administration’s Comprehensive, MultiYear Nutrition Innovation Strategy; 

Public Meeting; Request for Comments.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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. 


amozie on DSK3GDR082PROD with NOTICES1