81 FR 36931 - Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 81, Issue 110 (June 8, 2016)

Page Range		36931-36931
FR Document		2016-13523

Federal Register, Volume 81 Issue 110 (Wednesday, June 8, 2016)

[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Page 36931]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Advisory Committee on Training in Primary Care Medicine and 
Dentistry; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:
    Name: Advisory Committee on Training in Primary Care Medicine and 
Dentistry (ACTPCMD).
    Dates and Times: June 28, 2016 (Day 1--8:30 a.m.-5:00 p.m., EST), 
June 29, 2016 (Day 2--8:30 a.m.-5:00 p.m., EST).
    Place: In-Person Meeting with Webinar/Conference Call Component, 
5600 Fishers Lane, Room 5E29, Rockville, MD 20857.
    Status: The meeting will be open to the public.
    Purpose: The ACTPCMD provides advice and recommendations on a broad 
range of issues relating to grant programs authorized by title VII, 
part C, sections 747 and 748 of the Public Health Service Act (PHSA). 
During the June 28-29, 2016 meeting, the Committee will discuss the 
topic for the 14th report which is divided into two areas: a) Review of 
Primary Care Medicine and Dentistry Programs under title VII, part C of 
the PHSA and b) the ways to integrate behavioral health content into 
primary care medicine and dentistry training programs.
    Agenda: The purpose of the Advisory Committee meeting is two-fold: 
a) Review the activities under sections 747 and 748, part C of title 
VII of the PHS Act including performance measures, longitudinal 
evaluations, and appropriation levels for these programs; and b) review 
ways that behavioral health content could be integrated into primary 
care education and training. The Committee has identified that 
integrating behavioral health services into primary care settings 
offers a promising, viable, and efficient way of ensuring that people 
have access to needed behavioral health services. The ACTPCMD's reports 
are submitted to the Secretary of the Department of Health and Human 
Services; the Committee on Health, Education, Labor, and Pensions of 
the Senate; and the Committee on Energy and Commerce of the House of 
Representatives. The ACTPCMD agenda will be available 2 days prior to 
the meeting on the HRSA Web site at http://www.hrsa.gov/advisorycommittees/bhpradvisory/actpcmd/index.html.

SUPPLEMENTARY INFORMATION: Requests to make oral comments or provide 
written comments to the ACTPCMD should be sent to Dr. Joan Weiss, 
Designated Federal Official, using the address and phone number below. 
Individuals who plan to make oral comments or provide written comments 
to the ACTPCMD should notify Dr. Weiss at least 3 days prior to the 
meeting, using the address or phone number below. Members of the public 
will have the opportunity to provide comments. Individuals who plan to 
attend and need special assistance, such as sign language 
interpretation or other reasonable accommodations, should notify Dr. 
Weiss at least 10 days prior to the meeting.
     The conference call-in number is 1-800-619-2521. The 
passcode is 9271697.
     The webinar link is https://hrsa.connectsolutions.com/actpcmd.
    Contact: Anyone requesting information regarding the ACTPCMD should 
contact Dr. Joan Weiss, Designated Federal Official within the Bureau 
of Health Workforce, Health Resources and Services Administration, in 
one of three ways: (1) Send a request to the following address: Dr. 
Joan Weiss, Designated Federal Official, Bureau of Health Workforce, 
Health Resources and Services Administration, 5600 Fishers Lane, Room 
15N39, Rockville, Maryland 20857; (2) call (301) 443-0430; or (3) send 
an email to [email protected].

Jason Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-13523 Filed 6-7-16; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices 36931

determining this patent’s eligibility for period. To meet its burden, the petition appropriation levels for these programs;
patent term restoration. In a letter dated must be timely (see DATES) and contain and b) review ways that behavioral
October 19, 2015, FDA advised the sufficient facts to merit an FDA health content could be integrated into
USPTO that this human biological investigation. (See H. Rept. 857, part 1, primary care education and training.
product had undergone a regulatory 98th Cong., 2d sess., pp. 41–42, 1984.) The Committee has identified that
review period and that the approval of Petitions should be in the format integrating behavioral health services
ELOCTATE represented the first specified in 21 CFR 10.30. into primary care settings offers a
permitted commercial marketing or use Submit petitions electronically to promising, viable, and efficient way of
of the product. Thereafter, the USPTO http://www.regulations.gov at Docket ensuring that people have access to
requested that FDA determine the No. FDA–2013–S–0610. Submit written needed behavioral health services. The
product’s regulatory review period. petitions (two copies are required) to the ACTPCMD’s reports are submitted to
Division of Dockets Management (HFA– the Secretary of the Department of
II. Determination of Regulatory Review
305), Food and Drug Administration,
Period Health and Human Services; the
5630 Fishers Lane, Rm. 1061, Rockville,
FDA has determined that the Committee on Health, Education, Labor,
MD 20852.
applicable regulatory review period for and Pensions of the Senate; and the
Dated: June 2, 2016. Committee on Energy and Commerce of
ELOCTATE is 1,695 days. Of this time,
1,239 days occurred during the testing Leslie Kux, the House of Representatives. The
phase of the regulatory review period, Associate Commissioner for Policy. ACTPCMD agenda will be available 2
while 456 days occurred during the [FR Doc. 2016–13521 Filed 6–7–16; 8:45 am] days prior to the meeting on the HRSA
approval phase. These periods of time BILLING CODE 4164–01–P Web site at http://www.hrsa.gov/
were derived from the following dates: advisorycommittees/bhpradvisory/
1. The date an exemption under actpcmd/index.html.
section 505(i) of the Federal Food, Drug, DEPARTMENT OF HEALTH AND
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Requests
and Cosmetic Act (21 U.S.C. 355(i))
became effective: October 17, 2009. The to make oral comments or provide
applicant claims December 10, 2009, as Health Resources and Service written comments to the ACTPCMD
the date the investigational new drug Administration should be sent to Dr. Joan Weiss,
application (IND) became effective. Designated Federal Official, using the
Advisory Committee on Training in address and phone number below.
However, FDA records indicate that the Primary Care Medicine and Dentistry;
IND effective date was October 17, 2009, Individuals who plan to make oral
Notice of Meeting comments or provide written comments
which was 30 days after FDA receipt of
the IND. In accordance with section 10(a)(2) of to the ACTPCMD should notify Dr.
2. The date the application was the Federal Advisory Committee Act Weiss at least 3 days prior to the
initially submitted with respect to the (Pub. L. 92–463), notice is hereby given meeting, using the address or phone
human biological product under section of the following meeting: number below. Members of the public
351 of the Public Health Service Act (42 Name: Advisory Committee on will have the opportunity to provide
U.S.C. 262): March 8, 2013. The Training in Primary Care Medicine and comments. Individuals who plan to
applicant claims March 7, 2013, as the Dentistry (ACTPCMD). attend and need special assistance, such
date the biologics license application Dates and Times: June 28, 2016 (Day as sign language interpretation or other
(BLA) for ELOCTATE (BLA 125487/0) 1—8:30 a.m.–5:00 p.m., EST), June 29, reasonable accommodations, should
was initially submitted. However, FDA 2016 (Day 2—8:30 a.m.–5:00 p.m., EST). notify Dr. Weiss at least 10 days prior
records indicate that BLA 125487/0 was Place: In-Person Meeting with to the meeting.
submitted on March 8, 2013. Webinar/Conference Call Component,
3. The date the application was 5600 Fishers Lane, Room 5E29, • The conference call-in number is 1–
approved: June 6, 2014. FDA has Rockville, MD 20857. 800–619–2521. The passcode is
verified the applicant’s claim that BLA Status: The meeting will be open to 9271697.
125487/0 was approved on June 6, 2014. the public. • The webinar link is https://hrsa.
This determination of the regulatory Purpose: The ACTPCMD provides connectsolutions.com/actpcmd.
review period establishes the maximum advice and recommendations on a broad
Contact: Anyone requesting
potential length of a patent extension. range of issues relating to grant
information regarding the ACTPCMD
However, the USPTO applies several programs authorized by title VII, part C,
sections 747 and 748 of the Public should contact Dr. Joan Weiss,
statutory limitations in its calculations
Health Service Act (PHSA). During the Designated Federal Official within the
of the actual period for patent extension.
June 28–29, 2016 meeting, the Bureau of Health Workforce, Health
In its application for patent extension,
Committee will discuss the topic for the Resources and Services Administration,
this applicant seeks 1,049 days, 740
14th report which is divided into two in one of three ways: (1) Send a request
days, 854 days, or 500 days,
respectively, of patent term extension. areas: a) Review of Primary Care to the following address: Dr. Joan Weiss,
Medicine and Dentistry Programs under Designated Federal Official, Bureau of
III. Petitions title VII, part C of the PHSA and b) the Health Workforce, Health Resources and
Anyone with knowledge that any of ways to integrate behavioral health Services Administration, 5600 Fishers
the dates as published are incorrect may content into primary care medicine and Lane, Room 15N39, Rockville, Maryland
mstockstill on DSK3G9T082PROD with NOTICES

submit either electronic or written dentistry training programs. 20857; (2) call (301) 443–0430; or (3)
comments and ask for a redetermination Agenda: The purpose of the Advisory send an email to jweiss@hrsa.gov.
(see DATES). Furthermore, any interested Committee meeting is two-fold: a)
Jason Bennett,
person may petition FDA for a Review the activities under sections 747
determination regarding whether the and 748, part C of title VII of the PHS Director, Division of the Executive Secretariat.
applicant for extension acted with due Act including performance measures, [FR Doc. 2016–13523 Filed 6–7–16; 8:45 am]
diligence during the regulatory review longitudinal evaluations, and BILLING CODE 4165–15–P

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Document Created: 2016-06-08 03:10:31
Document Modified: 2016-06-08 03:10:31

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
FR Citation		81 FR 36931

81 FR 36931 - Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Service Administration

Federal Register Volume 81, Issue 110 (June 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration