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product was withdrawn for reasons of 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product was withdrawn from sale for 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
42514 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Claudine Kavanaugh, Food and Drug 

Administration, Office of Foods and 

Veterinary Medicine, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 3218, 

Silver Spring, MD 20993, 301–796– 

4647. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 27, 2018 (83 FR 

30180), FDA announced that it would 

hold a public meeting entitled ‘‘FDA’s 

Comprehensive, Multi-Year Nutrition 

Innovation Strategy.’’ The public 

meeting, which we held on July 26, 

2018, was intended to give interested 

persons an opportunity to discuss FDA’s 

Nutrition Innovation Strategy and to 

provide input on ways to modernize 

FDA’s approach to better protect public 

health while removing barriers to 

industry innovation. We stated that the 

topics to be addressed at the meeting 

would include the following: 

• Considering using a standard icon 

to denote the claim ‘‘healthy’’ on food 

labels. 

• Creating a more efficient review 

strategy for evaluating qualified health 

claims on food labels. 

• Discussing new or enhanced 

labeling statements or claims that could 

facilitate innovation to produce more 

healthful foods and more healthful 

consumer food choices. 

• Modernizing the standards of 

identity to provide more flexibility for 

the development of healthier products, 

while making sure consumers have 

accurate information about these food 

products. 

• Providing opportunities to make 

ingredient information more helpful to 

consumers. 

• FDA’s educational campaign for 

consumers about the updated Nutrition 

Facts label. 

See 83 FR 30180 at 30181 to 30182. 

The notice invited interested parties 

to provide information on these and 

other topics related to FDA’s Nutrition 

Innovation Strategy. We asked that 

comments be submitted on or before 

August 27, 2018. 

After the public meeting, we received 

several requests to extend the comment 

period. The requesters asserted that the 

time period of 32 days was insufficient 

to respond fully to FDA’s specific 

request for comments and to ensure 

comprehensive public input and allow 

potential respondents to thoroughly 

evaluate and address pertinent issues. 

We have considered the requests and 

are extending the comment period for 

another 45 days, until October 11, 2018. 

We believe that a 45-day extension 

allows adequate time for interested 

persons to submit comments while 

ensuring the continued forward progress 

of FDA’s Nutrition Innovation Strategy. 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18072 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–2999] 

Determination That DANOCRINE 

(Danazol) Capsules, 50 Milligrams, 100 

Milligrams, and 200 Milligrams, Were 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness Except the 

Indication of Fibrocystic Breast 

Disease, Which Was 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 DANOCRINE (danazol) 

Capsules, 50 milligrams (mg), 100 mg, 

and 200 mg, were not withdrawn from 

sale for reasons of safety or 

effectiveness, except with respect to the 

indication of fibrocystic breast disease 

that was withdrawn for reasons of safety 

or effectiveness. This determination 

means that FDA will not begin 

procedures to suspend approval of 

abbreviated new drug applications 

(ANDAs) that refer to this drug product 

and have removed the indication for 

fibrocystic breast disease. This 

determination also will allow FDA to 

continue to approve ANDAs that refer to 

this drug as long as they meet relevant 

legal and regulatory requirements. 

However, the Agency will not accept or 

approve ANDAs for DANOCRINE 

(danazol) Capsules, 50 mg, 100 mg, and 

200 mg that include fibrocystic breast 

disease as an indication. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363. 

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. 

Under § 314.161(a)(2), the Agency 

must also determine whether a listed 

drug was withdrawn from sale for 

reasons of safety or effectiveness if 

ANDAs that referred to the listed drug 

have already been approved prior to its 

market withdrawal. If the Agency 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, and there are 

approved ANDAs that reference that 

listed drug, FDA will initiate a 

proceeding to determine whether the 

suspension of the ANDAs is also 

required (§ 314.161(d)). 

DANOCRINE (danazol) Capsules, 50 

mg, 100 mg, and 200 mg, is the subject 

of NDA 017557 held by Sanofi-Aventis, 

and initially approved on June 21, 1976. 

DANOCRINE is indicated for the 

treatment of endometriosis amenable to 

hormonal management, prevention of 

attacks of angioedema of all types 

(cutaneous, abdominal, and laryngeal) 

in males and females, and fibrocystic 

breast disease. Specifically, with respect 

to fibrocystic breast disease, the labeling 

states ‘‘Most cases of fibrocystic breast 

disease may be treated by simple 


amozie on DSK3GDR082PROD with NOTICES1