83 FR 42515 - Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 163 (August 22, 2018)
Federal Register Volume 83, Issue 163 (August 22, 2018)
| Page Range | 42515-42516 | |
| FR Document | 2018-18074 |
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)] [Notices] [Pages 42515-42516] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18074] ----------------------------------------------------------------------- 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/primarycare-dentist/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 [email protected]. 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 [[Page 42516]] 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
![Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42515
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 KCarter@hrsa.gov.
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
Sanofi-Aventis requested the ACTPCMD provides advice and
have a favorable benefit-risk profile. recommendations to the Secretary of
withdrawal of the DANOCRINE Accordingly, the Agency will
application. On July 19, 2013, the HHS (Secretary) on policy, program
continue to list DANOCRINE (danazol) development, and other matters of
Agency issued a Federal Register notice Capsules, 50 mg, 100 mg, and 200 mg,
withdrawing NDA 017557, the significance concerning the activities
in the ‘‘Discontinued Drug Product List’’ under section 747 of Title VII of the
application for DANOCRINE, effective section of the Orange Book. All
August 19, 2013. Public Health Service (PHS) Act, as it
approved ANDAs have removed the existed upon the enactment of Section
After reviewing our records and based
fibrocystic breast disease indication 749 of the PHS Act in 1998. ACTPCMD
on the information we have at this time,
from their labeling. In addition, FDA prepares an annual report describing the
FDA has determined that under
will continue to approve ANDAs that activities of the Committee, including
§ 314.161 DANOCRINE (danazol)
refer to DANOCRINE (danazol) Capsules findings and recommendations made by
Capsules, 50 mg, 100 mg, and 200 mg,
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
breast pain 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,
when it is in fact the result of normal publishes, and implements performance
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
amozie on DSK3GDR082PROD with NOTICES1
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
VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/83_FR_42678/page/1.svg)
![42516 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
and may be limited as time allows. Rockville, MD 20857; (301) 443–6593, injury, condition, or death described in
Requests to make oral comments or or visit our website at: http:// the petition is due to factors unrelated
submit a written statement to www.hrsa.gov/vaccinecompensation/ to the administration of the vaccine
ACTPCMD should be sent to Dr. index.html. described in the petition,’’ and
Kennita R. Carter, DFO, using the SUPPLEMENTARY INFORMATION: The 2. Any allegation in a petition that the
contact information above at least 3 Program provides a system of no-fault petitioner either:
business days prior to the meeting. compensation for certain individuals a. ‘‘[S]ustained, or had significantly
Individuals who plan to attend and aggravated, any illness, disability,
who have been injured by specified
need special assistance or another injury, or condition not set forth in the
childhood vaccines. Subtitle 2 of Title
reasonable accommodation should Vaccine Injury Table but which was
XXI of the PHS Act, 42 U.S.C. 300aa–
notify Dr. Kennita R. Carter at the caused by’’ one of the vaccines referred
10 et seq., provides that those seeking
address and phone number listed above to in the Table, or
compensation are to file a petition with
at least 10 business days prior to the
the U.S. Court of Federal Claims and to b. ‘‘[S]ustained, or had significantly
meeting. Since this meeting occurs in a
serve a copy of the petition on the aggravated, any illness, disability,
federal government building, attendees
Secretary of Health and Human injury, or condition set forth in the
must go through a security check to
Services, who is named as the Vaccine Injury Table the first symptom
enter the building. Non-U.S. Citizen
respondent in each proceeding. The or manifestation of the onset or
attendees must notify HRSA of their
Secretary has delegated this significant aggravation of which did not
planned attendance at least 10 business
responsibility under the Program to occur within the time period set forth in
days prior to the meeting in order to
HRSA. The Court is directed by statute the Table but which was caused by a
facilitate their entry into the building.
to appoint special masters who take vaccine’’ referred to in the Table.
All attendees are required to present
government-issued identification prior evidence, conduct hearings as In accordance with Section
to entry. appropriate, and make initial decisions 2112(b)(2), all interested persons may
as to eligibility for, and amount of, submit written information relevant to
Amy P. McNulty, compensation. the issues described above in the case of
Acting Director, Division of the Executive A petition may be filed with respect the petitions listed below. Any person
Secretariat. to injuries, disabilities, illnesses, choosing to do so should file an original
[FR Doc. 2018–18074 Filed 8–21–18; 8:45 am] conditions, and deaths resulting from and three (3) copies of the information
BILLING CODE 4165–15–P vaccines described in the Vaccine Injury with the Clerk of the U.S. Court of
Table (the Table) set forth at 42 CFR Federal Claims at the address listed
100.3. This Table lists for each covered above (under the heading FOR FURTHER
DEPARTMENT OF HEALTH AND childhood vaccine the conditions that INFORMATION CONTACT), with a copy to
HUMAN SERVICES may lead to compensation and, for each HRSA addressed to Director, Division of
condition, the time period for Injury Compensation Programs,
Health Resources and Services occurrence of the first symptom or Healthcare Systems Bureau, 5600
Administration manifestation of onset or of significant Fishers Lane, 08N146B, Rockville, MD
aggravation after vaccine 20857. The Court’s caption (Petitioner’s
National Vaccine Injury Compensation
administration. Compensation may also Name v. Secretary of Health and Human
Program; List of Petitions Received
be awarded for conditions not listed in Services) and the docket number
AGENCY: Health Resources and Services the Table and for conditions that are assigned to the petition should be used
Administration (HRSA), Department of manifested outside the time periods as the caption for the written
Health and Human Services (HHS). specified in the Table, but only if the submission. Chapter 35 of title 44,
ACTION: Notice. petitioner shows that the condition was United States Code, related to
caused by one of the listed vaccines. paperwork reduction, does not apply to
SUMMARY: HRSA is publishing this Section 2112(b)(2) of the PHS Act, 42 information required for purposes of
notice of petitions received under the U.S.C. 300aa–12(b)(2), requires that carrying out the Program.
National Vaccine Injury Compensation ‘‘[w]ithin 30 days after the Secretary Dated: August 16, 2018.
Program (the Program), as required by receives service of any petition filed
the Public Health Service (PHS) Act, as George Sigounas,
under section 2111 the Secretary shall
amended. While the Secretary of HHS is Administrator.
publish notice of such petition in the
named as the respondent in all Federal Register.’’ Set forth below is a List of Petitions Filed
proceedings brought by the filing of list of petitions received by HRSA on
petitions for compensation under the July 1, 2018, through July 31, 2018. This 1. Gregory Jackson, Stevensville,
Program, the United States Court of list provides the name of petitioner, city Maryland, Court of Federal Claims
Federal Claims is charged by statute and state of vaccination (if unknown No: 18–0949V
with responsibility for considering and then city and state of person or attorney 2. Debra D. Nicholson, West Baden,
acting upon the petitions. filing claim), and case number. In cases Indiana, Court of Federal Claims
FOR FURTHER INFORMATION CONTACT: For where the Court has redacted the name No: 18–0953V
information about requirements for of a petitioner and/or the case number, 3. Deborah Spivey, Carthage, Tennessee,
filing petitions, and the Program in the list reflects such redaction. Court of Federal Claims No: 18–
general, contact Lisa L. Reyes, Clerk of Section 2112(b)(2) also provides that 0959V
amozie on DSK3GDR082PROD with NOTICES1
Court, United States Court of Federal the special master ‘‘shall afford all 4. Shauna Rhyne and Cody Rhyne on
Claims, 717 Madison Place NW, interested persons an opportunity to behalf of C. R., Grand Junction,
Washington, DC 20005, (202) 357–6400. submit relevant, written information’’ Colorado, Court of Federal Claims
For information on HRSA’s role in the relating to the following: No: 18–0961V
Program, contact the Director, National 1. The existence of evidence ‘‘that 5. Chris Skye and Lesley Skye on behalf
Vaccine Injury Compensation Program, there is not a preponderance of the of D. S., Novato, California, Court of
5600 Fishers Lane, Room 08N146B, evidence that the illness, disability, Federal Claims No: 18–0962V
VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/83_FR_42678/page/2.svg)
Document Created: 2018-08-22 00:38:27
Document Modified: 2018-08-22 00:38:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| 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. | |
| 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 [email protected] | |
| FR Citation | 83 FR 42515 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR