42514 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices

FOR FURTHER INFORMATION CONTACT: ensuring the continued forward progress must, with certain exceptions, show that Claudine Kavanaugh, Food and Drug of FDA’s Nutrition Innovation Strategy. the drug for which they are seeking Administration, Office of Foods and Dated: August 16, 2018. approval contains the same active ingredient in the same strength and Veterinary Medicine, 10903 New Leslie Kux, Hampshire Ave., Bldg. 1, Rm. 3218, dosage form as the ‘‘listed drug,’’ which Associate Commissioner for Policy. Silver Spring, MD 20993, 301–796– is a version of the drug that was 4647. [FR Doc. 2018–18072 Filed 8–21–18; 8:45 am] previously approved. ANDA applicants BILLING CODE 4164–01–P do not have to repeat the extensive SUPPLEMENTARY INFORMATION: In the clinical testing otherwise necessary to Federal Register of June 27, 2018 (83 FR gain approval of a new drug application 30180), FDA announced that it would DEPARTMENT OF HEALTH AND (NDA). hold a public meeting entitled ‘‘FDA’s HUMAN SERVICES The 1984 amendments include what Comprehensive, Multi-Year Nutrition is now section 505(j)(7) of the Federal Food and Drug Administration Innovation Strategy.’’ The public Food, Drug, and Cosmetic Act (21 U.S.C. meeting, which we held on July 26, [Docket No. FDA–2018–N–2999] 355(j)(7)), which requires FDA to 2018, was intended to give interested publish a list of all approved drugs. persons an opportunity to discuss FDA’s Determination That DANOCRINE FDA publishes this list as part of the Nutrition Innovation Strategy and to (Danazol) Capsules, 50 Milligrams, 100 ‘‘Approved Drug Products With provide input on ways to modernize Milligrams, and 200 Milligrams, Were Therapeutic Equivalence Evaluations,’’ FDA’s approach to better protect public Not Withdrawn From Sale for Reasons which is known generally as the health while removing barriers to of Safety or Effectiveness Except the ‘‘Orange Book.’’ Under FDA regulations, industry innovation. We stated that the Indication of Fibrocystic Breast drugs are removed from the list if the topics to be addressed at the meeting Disease, Which Was Withdrawn From Agency withdraws or suspends would include the following: Sale for Reasons of Safety or • approval of the drug’s NDA or ANDA Considering using a standard icon Effectiveness for reasons of safety or effectiveness or to denote the claim ‘‘healthy’’ on food if FDA determines that the listed drug labels. AGENCY: Food and Drug Administration, • HHS. was withdrawn from sale for reasons of Creating a more efficient review safety or effectiveness (21 CFR 314.162). strategy for evaluating qualified health ACTION: Notice. A person may petition the Agency to claims on food labels. determine, or the Agency may • Discussing new or enhanced SUMMARY: The Food and Drug Administration (FDA or Agency) has determine on its own initiative, whether labeling statements or claims that could a listed drug was withdrawn from sale facilitate innovation to produce more determined that DANOCRINE (danazol) Capsules, 50 milligrams (mg), 100 mg, for reasons of safety or effectiveness. healthful foods and more healthful This determination may be made at any consumer food choices. and 200 mg, were not withdrawn from sale for reasons of safety or time after the drug has been withdrawn • Modernizing the standards of from sale, but must be made prior to identity to provide more flexibility for effectiveness, except with respect to the indication of fibrocystic breast disease approving an ANDA that refers to the the development of healthier products, listed drug (§ 314.161 (21 CFR 314.161)). while making sure consumers have that was withdrawn for reasons of safety or effectiveness. This determination FDA may not approve an ANDA that accurate information about these food does not refer to a listed drug. means that FDA will not begin products. Under § 314.161(a)(2), the Agency procedures to suspend approval of • Providing opportunities to make must also determine whether a listed ingredient information more helpful to abbreviated new drug applications drug was withdrawn from sale for consumers. (ANDAs) that refer to this drug product reasons of safety or effectiveness if • FDA’s educational campaign for and have removed the indication for ANDAs that referred to the listed drug consumers about the updated Nutrition fibrocystic breast disease. This have already been approved prior to its Facts label. determination also will allow FDA to market withdrawal. If the Agency See 83 FR 30180 at 30181 to 30182. continue to approve ANDAs that refer to determines that a listed drug was The notice invited interested parties this drug as long as they meet relevant withdrawn from sale for reasons of to provide information on these and legal and regulatory requirements. safety or effectiveness, and there are other topics related to FDA’s Nutrition However, the Agency will not accept or approved ANDAs that reference that Innovation Strategy. We asked that approve ANDAs for DANOCRINE listed drug, FDA will initiate a comments be submitted on or before (danazol) Capsules, 50 mg, 100 mg, and proceeding to determine whether the August 27, 2018. 200 mg that include fibrocystic breast suspension of the ANDAs is also After the public meeting, we received disease as an indication. required (§ 314.161(d)). several requests to extend the comment FOR FURTHER INFORMATION CONTACT: DANOCRINE (danazol) Capsules, 50 period. The requesters asserted that the Stacy Kane, Center for Drug Evaluation mg, 100 mg, and 200 mg, is the subject time period of 32 days was insufficient and Research, Food and Drug of NDA 017557 held by Sanofi-Aventis, to respond fully to FDA’s specific Administration, 10903 New Hampshire and initially approved on June 21, 1976. request for comments and to ensure Ave., Bldg. 51, Rm. 6236, Silver Spring, DANOCRINE is indicated for the comprehensive public input and allow MD 20993–0002, 301–796–8363. treatment of amenable to potential respondents to thoroughly SUPPLEMENTARY INFORMATION: In 1984, hormonal management, prevention of evaluate and address pertinent issues. Congress enacted the Drug Price attacks of of all types We have considered the requests and Competition and Patent Term (cutaneous, abdominal, and laryngeal) are extending the comment period for Restoration Act of 1984 (Pub. L. 98–417) in males and females, and fibrocystic another 45 days, until October 11, 2018. (the 1984 amendments), which breast disease. Specifically, with respect We believe that a 45-day extension authorized the approval of duplicate to fibrocystic breast disease, the labeling allows adequate time for interested versions of drug products under an states ‘‘Most cases of fibrocystic breast persons to submit comments while ANDA procedure. ANDA applicants disease may be treated by simple

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measures (e.g., padded brassieres and treatment of fibrocystic breast disease, DATES: September 10, 2018, 9:00 a.m.– analgesics). In infrequent patients, the Agency concluded that the benefit- 5:00 p.m. ET, and September 11, 2018, symptoms of pain and tenderness may risk profile of the product is unfavorable 8:30 a.m.–2:30 p.m. ET. be severe enough to warrant treatment given the risk of potentially serious ADDRESSES: This meeting will be held in by suppression of ovarian function. adverse reactions and that the condition person and offer virtual access through DANOCRINE is usually effective in is a benign, non-disease state. In teleconference and webinar. The decreasing nodularity, pain, and addition, many other treatment options address for the meeting is 5600 Fishers tenderness. It should be stressed to the exist for this condition, including Lane, Rockville, Maryland 20857. patient that this treatment is not dietary measures, use of supportive • Conference call-in number: 1–800– innocuous in that it involves undergarments and pain relievers such 238–9007; Passcode: 532320. considerable alterations of hormone as acetaminophen or non-steroidal anti- • Webinar link: https:// levels and that recurrence of symptoms inflammatory drug products. Many of hrsa.connectsolutions.com/actpcmd. is very common after cessation of these treatment options present a very FOR FURTHER INFORMATION CONTACT: Dr. therapy.’’ low risk of adverse reactions. For the Kennita Carter, Designated Federal DANOCRINE (danazol) Capsules, 50 indications of treatment of Official (DFO), Division of Medicine mg, 100 mg, and 200 mg, were endometriosis amenable to hormone and Dentistry, Bureau of Health discontinued from sale in December management and prevention of attacks Workforce, HRSA, 5600 Fishers Lane, 2004. FDA moved the product to the of angioedema of all types (cutaneous, 15N–116, Rockville, Maryland 20857; ‘‘Discontinued Drug Product List’’ abdominal, and laryngeal) in males and 301–945–3505; or [email protected]. section of the Orange Book at that time. females, the Agency has determined that SUPPLEMENTARY INFORMATION: In a letter dated October 17, 2011, DANOCRINE (danazol) continues to ACTPCMD provides advice and Sanofi-Aventis requested the have a favorable benefit-risk profile. withdrawal of the DANOCRINE recommendations to the Secretary of Accordingly, the Agency will HHS (Secretary) on policy, program application. On July 19, 2013, the continue to list DANOCRINE (danazol) Agency issued a Federal Register notice development, and other matters of Capsules, 50 mg, 100 mg, and 200 mg, significance concerning the activities withdrawing NDA 017557, the in the ‘‘Discontinued Drug Product List’’ application for DANOCRINE, effective under section 747 of Title VII of the section of the Orange Book. All Public Health Service (PHS) Act, as it August 19, 2013. approved ANDAs have removed the After reviewing our records and based existed upon the enactment of Section fibrocystic breast disease indication on the information we have at this time, 749 of the PHS Act in 1998. ACTPCMD from their labeling. In addition, FDA FDA has determined that under prepares an annual report describing the will continue to approve ANDAs that § 314.161 DANOCRINE (danazol) activities of the Committee, including refer to DANOCRINE (danazol) Capsules Capsules, 50 mg, 100 mg, and 200 mg, findings and recommendations made by were not withdrawn from sale for as long as they meet relevant legal and the Committee concerning the activities reasons of safety or effectiveness, except regulatory requirements, but FDA will under section 747, as well as training with respect to the indication for not accept or approve ANDAs that refer programs in oral health and dentistry. fibrocystic breast disease. Fibrocystic to this drug product and propose to The annual report is submitted to the breast disease refers to mastalgia or include the fibrocystic breast disease Secretary and Chairman and ranking caused by benign indication. members of the Senate Committee on proliferative breast tissue. The term Dated: August 16, 2018. Health, Education, Labor and Pensions, fibrocystic breast disease is no longer Leslie Kux, and the House of Representatives used, in part because it is not accurate Associate Commissioner for Policy. Committee on Energy and Commerce. to describe the condition as a disease [FR Doc. 2018–18081 Filed 8–21–18; 8:45 am] The Committee also develops, publishes, and implements performance when it is in fact the result of normal BILLING CODE 4164–01–P physiologic changes. measures and guidelines for DANOCRINE (danazol) has been longitudinal evaluations of programs associated with two serious adverse DEPARTMENT OF HEALTH AND authorized under Title VII, Part C, of the reactions: hepatocellular injury (i.e., HUMAN SERVICES PHS Act, and recommends hepatocellular injury, hepatocellular appropriation levels for programs under jaundice, and hepatic failure) and an Meeting of the Advisory Committee on this Part. increased risk of rhabdomyolysis in Training in Primary Care Medicine and During the September 10–11, 2018, patients taking danazol and statins. Dentistry meeting, ACTPCMD will have follow-up These two adverse reactions were not discussions on PHS Act section 747 and yet recognized when DANOCRINE AGENCY: Health Resources and Service oral health training programs, and (danazol) was originally approved for Administration (HRSA), Department of finalize its recommendations on funding fibrocystic breast disease in 1980. Both Health and Human Services (HHS). and appropriation levels to be included of these adverse reactions were added to ACTION: Notice of meeting. in its 16th report. In addition, the the safety labeling for the product Committee will complete the 16th several years after the product was SUMMARY: In accordance with the report and a pending report on initially approved. In addition, Federal Advisory Committee Act, this promoting clinical trainee and faculty androgenic adverse effects and a notice announces that the Advisory well-being and mitigating burnout. contraindication for use in women who Committee on Training in Primary Care Agenda items are subject to change as are pregnant or attempting to become Medicine and Dentistry (ACTPCMD) priorities dictate. pregnant limit the utility of will hold a public meeting. Information Members of the public will have the DANOCRINE (danazol) for the about ACTPCMD and the agenda for this opportunity to provide comments. fibrocystic breast disease indication. meeting can be found on the ACTPCMD Public participants may submit written The Agency conducted a review of the website at: https://www.hrsa.gov/ statements in advance of the scheduled benefit-risk profile for each indication of advisory-committees/primarycare- meeting. Oral comments will be DANOCRINE (danazol). For the dentist/index.html. honored in the order they are requested

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