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 


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Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42515 

measures (e.g., padded brassieres and 

analgesics). In infrequent patients, 

symptoms of pain and tenderness may 

be severe enough to warrant treatment 

by suppression of ovarian function. 

DANOCRINE is usually effective in 

decreasing nodularity, pain, and 

tenderness. It should be stressed to the 

patient that this treatment is not 

innocuous in that it involves 

considerable alterations of hormone 

levels and that recurrence of symptoms 

is very common after cessation of 

therapy.’’ 

DANOCRINE (danazol) Capsules, 50 

mg, 100 mg, and 200 mg, were 

discontinued from sale in December 

2004. FDA moved the product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book at that time. 

In a letter dated October 17, 2011, 

Sanofi-Aventis requested the 

withdrawal of the DANOCRINE 

application. On July 19, 2013, the 

Agency issued a Federal Register notice 

withdrawing NDA 017557, the 

application for DANOCRINE, effective 

August 19, 2013. 

After reviewing our records and based 

on the information we have at this time, 

FDA has determined that under 

§ 314.161 DANOCRINE (danazol) 

Capsules, 50 mg, 100 mg, and 200 mg, 

were not withdrawn from sale for 

reasons of safety or effectiveness, except 

with respect to the indication for 

fibrocystic breast disease. Fibrocystic 

breast disease refers to mastalgia or 

breast pain caused by benign 

proliferative breast tissue. The term 

fibrocystic breast disease is no longer 

used, in part because it is not accurate 

to describe the condition as a disease 

when it is in fact the result of normal 

physiologic changes. 

DANOCRINE (danazol) has been 

associated with two serious adverse 

reactions: hepatocellular injury (i.e., 

hepatocellular injury, hepatocellular 

jaundice, and hepatic failure) and an 

increased risk of rhabdomyolysis in 

patients taking danazol and statins. 

These two adverse reactions were not 

yet recognized when DANOCRINE 

(danazol) was originally approved for 

fibrocystic breast disease in 1980. Both 

of these adverse reactions were added to 

the safety labeling for the product 

several years after the product was 

initially approved. In addition, 

androgenic adverse effects and a 

contraindication for use in women who 

are pregnant or attempting to become 

pregnant limit the utility of 

DANOCRINE (danazol) for the 

fibrocystic breast disease indication. 

The Agency conducted a review of the 

benefit-risk profile for each indication of 

DANOCRINE (danazol). For the 

treatment of fibrocystic breast disease, 

the Agency concluded that the benefitrisk profile of the product is unfavorable 

given the risk of potentially serious 

adverse reactions and that the condition 

is a benign, non-disease state. In 

addition, many other treatment options 

exist for this condition, including 

dietary measures, use of supportive 

undergarments and pain relievers such 

as acetaminophen or non-steroidal antiinflammatory drug products. Many of 

these treatment options present a very 

low risk of adverse reactions. For the 

indications of treatment of 

endometriosis amenable to hormone 

management and prevention of attacks 

of angioedema of all types (cutaneous, 

abdominal, and laryngeal) in males and 

females, the Agency has determined that 

DANOCRINE (danazol) continues to 

have a favorable benefit-risk profile. 

Accordingly, the Agency will 

continue to list DANOCRINE (danazol) 

Capsules, 50 mg, 100 mg, and 200 mg, 

in the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. All 

approved ANDAs have removed the 

fibrocystic breast disease indication 

from their labeling. In addition, FDA 

will continue to approve ANDAs that 

refer to DANOCRINE (danazol) Capsules 

as long as they meet relevant legal and 

regulatory requirements, but FDA will 

not accept or approve ANDAs that refer 

to this drug product and propose to 

include the fibrocystic breast disease 

indication. 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18081 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Training in Primary Care Medicine and 

Dentistry 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Training in Primary Care 

Medicine and Dentistry (ACTPCMD) 

will hold a public meeting. Information 

about ACTPCMD and the agenda for this 

meeting can be found on the ACTPCMD 

website at: https://www.hrsa.gov/ 

advisory-committees/primarycaredentist/index.html. 

DATES: September 10, 2018, 9:00 a.m.– 

5:00 p.m. ET, and September 11, 2018, 

8:30 a.m.–2:30 p.m. ET. 

ADDRESSES: This meeting will be held in 

person and offer virtual access through 

teleconference and webinar. The 

address for the meeting is 5600 Fishers 

Lane, Rockville, Maryland 20857. 

• Conference call-in number: 1–800– 

238–9007; Passcode: 532320. 

• Webinar link: https://

hrsa.connectsolutions.com/actpcmd. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Kennita Carter, Designated Federal 

Official (DFO), Division of Medicine 

and Dentistry, Bureau of Health 

Workforce, HRSA, 5600 Fishers Lane, 

15N–116, Rockville, Maryland 20857; 

301–945–3505; or KCarter@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

ACTPCMD provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning the activities 

under section 747 of Title VII of the 

Public Health Service (PHS) Act, as it 

existed upon the enactment of Section 

749 of the PHS Act in 1998. ACTPCMD 

prepares an annual report describing the 

activities of the Committee, including 

findings and recommendations made by 

the Committee concerning the activities 

under section 747, as well as training 

programs in oral health and dentistry. 

The annual report is submitted to the 

Secretary and Chairman and ranking 

members of the Senate Committee on 

Health, Education, Labor and Pensions, 

and the House of Representatives 

Committee on Energy and Commerce. 

The Committee also develops, 

publishes, and implements performance 

measures and guidelines for 

longitudinal evaluations of programs 

authorized under Title VII, Part C, of the 

PHS Act, and recommends 

appropriation levels for programs under 

this Part. 

During the September 10–11, 2018, 

meeting, ACTPCMD will have follow-up 

discussions on PHS Act section 747 and 

oral health training programs, and 

finalize its recommendations on funding 

and appropriation levels to be included 

in its 16th report. In addition, the 

Committee will complete the 16th 

report and a pending report on 

promoting clinical trainee and faculty 

well-being and mitigating burnout. 

Agenda items are subject to change as 

priorities dictate. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order they are requested 


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