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were not withdrawn from sale for 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 


amozie on DSK3GDR082PROD with NOTICES1
42516 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 

and may be limited as time allows. 

Requests to make oral comments or 

submit a written statement to 

ACTPCMD should be sent to Dr. 

Kennita R. Carter, DFO, using the 

contact information above at least 3 

business days prior to the meeting. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Dr. Kennita R. Carter at the 

address and phone number listed above 

at least 10 business days prior to the 

meeting. Since this meeting occurs in a 

federal government building, attendees 

must go through a security check to 

enter the building. Non-U.S. Citizen 

attendees must notify HRSA of their 

planned attendance at least 10 business 

days prior to the meeting in order to 

facilitate their entry into the building. 

All attendees are required to present 

government-issued identification prior 

to entry. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–18074 Filed 8–21–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, MD 20857; (301) 443–6593, 

or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the U.S. Court of Federal Claims and to 

serve a copy of the petition on the 

Secretary of Health and Human 

Services, who is named as the 

respondent in each proceeding. The 

Secretary has delegated this 

responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

July 1, 2018, through July 31, 2018. This 

list provides the name of petitioner, city 

and state of vaccination (if unknown 

then city and state of person or attorney 

filing claim), and case number. In cases 

where the Court has redacted the name 

of a petitioner and/or the case number, 

the list reflects such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Vaccine Injury Table but which was 

caused by’’ one of the vaccines referred 

to in the Table, or 

b. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 

In accordance with Section 

2112(b)(2), all interested persons may 

submit written information relevant to 

the issues described above in the case of 

the petitions listed below. Any person 

choosing to do so should file an original 

and three (3) copies of the information 

with the Clerk of the U.S. Court of 

Federal Claims at the address listed 

above (under the heading FOR FURTHER

INFORMATION CONTACT), with a copy to 

HRSA addressed to Director, Division of 

Injury Compensation Programs, 

Healthcare Systems Bureau, 5600 

Fishers Lane, 08N146B, Rockville, MD 

20857. The Court’s caption (Petitioner’s 

Name v. Secretary of Health and Human 

Services) and the docket number 

assigned to the petition should be used 

as the caption for the written 

submission. Chapter 35 of title 44, 

United States Code, related to 

paperwork reduction, does not apply to 

information required for purposes of 

carrying out the Program. 

Dated: August 16, 2018. 

George Sigounas, 

Administrator. 

List of Petitions Filed 

1. Gregory Jackson, Stevensville, 

Maryland, Court of Federal Claims 

No: 18–0949V 

2. Debra D. Nicholson, West Baden, 

Indiana, Court of Federal Claims 

No: 18–0953V 

3. Deborah Spivey, Carthage, Tennessee, 

Court of Federal Claims No: 18– 

0959V 

4. Shauna Rhyne and Cody Rhyne on 

behalf of C. R., Grand Junction, 

Colorado, Court of Federal Claims 

No: 18–0961V 

5. Chris Skye and Lesley Skye on behalf 

of D. S., Novato, California, Court of 

Federal Claims No: 18–0962V 


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