82 FR 41276 - CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 167 (August 30, 2017)

Page Range		41276-41277
FR Document		2017-18426

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. This meeting will be open to the public. Information about the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda for this meeting can be obtained by contacting CDR Holly Berilla at (301) 443-9965 or [email protected]

Federal Register, Volume 82 Issue 167 (Wednesday, August 30, 2017)

[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41276-41277]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD 
Prevention and Treatment

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, notice 
is hereby given that a meeting is scheduled for the Centers for Disease 
Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral 
Hepatitis and STD Prevention and Treatment. This meeting will be open 
to the public. Information about the CDC/HRSA Advisory Committee on 
HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda 
for this meeting can be obtained by contacting CDR Holly Berilla at 
(301) 443-9965 or [email protected].

DATES: October 25, 2017, 9:00 a.m. to 5:30 p.m. (Eastern) and October 
26, 2017, 9:00 a.m. to 4:15 p.m. (Eastern).

ADDRESSES: This meeting will be held in person and offer virtual access 
through teleconference and Adobe Connect. The address for the meeting 
is 5600 Fishers Lane, Pavilion, Rockville, Maryland 20857. The 
conference call-in number is (888) 469-0566 and passcode is 6012320. 
The webinar link is https://hrsa.connectsolutions.com/october_chac_meeting/.

FOR FURTHER INFORMATION CONTACT: Those requesting information regarding 
the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD 
Prevention and Treatment should contact CDR Holly Berilla, Senior 
Public Health Analyst, Division of Policy and Data (DPD), HIV/AIDS 
Bureau (HAB), HRSA, in one of three ways: (1) Mail a request to CDR 
Holly Berilla, Senior Public Health Analyst, HRSA/HAB/DPD, 5600 Fishers 
Lane, 9N164C, Rockville, Maryland 20857; (2) call (301) 443-9965; or 
(3) send an email to [email protected].

SUPPLEMENTARY INFORMATION: The CDC/HRSA Advisory Committee on HIV, 
Viral Hepatitis and STD Prevention and Treatment was established under 
Section 222 of the Public Health Service Act, [42 U.S.C. Section 217a], 
as amended.
    The purpose of the CDC/HRSA Advisory Committee on HIV, Viral 
Hepatitis and STD Prevention and Treatment is to advise the Secretary 
of HHS, the Director of CDC, and the Administrator of HRSA regarding 
objectives, strategies, policies, and priorities for HIV, viral 
hepatitis, and other STDs; prevention and treatment efforts including 
surveillance of HIV infection, AIDS, viral hepatitis and other STDs, 
and related behaviors; epidemiologic, behavioral, health services, and 
laboratory research on HIV/AIDS, viral hepatitis, and other STDs; 
identification of policy issues related to HIV/viral hepatitis/STD 
professional education, patient healthcare delivery, and prevention 
services; HHS policies about prevention of HIV/AIDS, viral hepatitis 
and other STDs; treatment, healthcare delivery, and research and 
training; strategic issues influencing the ability of CDC and HRSA to 
fulfill their missions of providing prevention and treatment services; 
programmatic efforts to prevent and treat HIV, viral hepatitis, and 
other STDs; and support to CDC and HRSA in their development of 
responses to emerging health needs related to HIV, viral hepatitis, and 
other STDs.
    During the October 25 to 26, 2017, meeting, the CDC/HRSA Advisory 
Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will 
discuss strategies to link, retain, and re-engage people living with 
HIV into the Ryan White HIV/AIDS Program system of care; HAB's 
benchmarking and risk adjustment initiatives; HRSA and CDC initiatives 
regarding congenital syphilis; and committee workgroup reports. Agenda 
items are subject to change as priorities dictate.
    Members of the public will have the opportunity to provide 
comments. Oral comments will be honored in the order they are requested 
and may be limited as time allows. Requests to make oral comments or 
provide written comments to the CDC/HRSA Advisory Committee on HIV, 
Viral Hepatitis and STD Prevention and Treatment should be sent to CDR 
Holly Berilla, using the contact information listed above, by October 
11, 2017.
    The building at 5600 Fishers Lane, Rockville, MD 20857, requires a 
security screening on entry. To facilitate your access to the building 
please contact CDR Holly Berilla (contact information provided above). 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify CDR Holly Berilla (contact information provided above) at least 
10 days prior to the meeting.

[[Page 41277]]

    Status: This advisory committee meeting will be open to the public.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-18426 Filed 8-29-17; 8:45 am]
 BILLING CODE 4165-15-P

41276 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices

was 30 days after FDA receipt of the DEPARTMENT OF HEALTH AND HHS, the Director of CDC, and the
IND. HUMAN SERVICES Administrator of HRSA regarding
2. The date the application was objectives, strategies, policies, and
Health Resources and Services priorities for HIV, viral hepatitis, and
initially submitted with respect to the
Administration other STDs; prevention and treatment
human drug product under section
505(b) of the FD&C Act: April 30, 2013. efforts including surveillance of HIV
CDC/HRSA Advisory Committee on
FDA has verified the applicant’s claim infection, AIDS, viral hepatitis and
HIV, Viral Hepatitis and STD Prevention
that the new drug application (NDA) for other STDs, and related behaviors;
and Treatment
KENGREAL (NDA 204958) was initially epidemiologic, behavioral, health
AGENCY: Health Resources and Service services, and laboratory research on
submitted on April 30, 2013.
Administration (HRSA), Department of HIV/AIDS, viral hepatitis, and other
3. The date the application was Health and Human Services (HHS). STDs; identification of policy issues
approved: June 22, 2015. FDA has ACTION: Notice of meeting. related to HIV/viral hepatitis/STD
verified the applicant’s claim that NDA professional education, patient
204958 was approved on June 22, 2015. SUMMARY: In accordance with the healthcare delivery, and prevention
Federal Advisory Committee Act, notice services; HHS policies about prevention
This determination of the regulatory is hereby given that a meeting is
review period establishes the maximum of HIV/AIDS, viral hepatitis and other
scheduled for the Centers for Disease
potential length of a patent extension. STDs; treatment, healthcare delivery,
Control and Prevention (CDC)/HRSA
However, the USPTO applies several and research and training; strategic
Advisory Committee on HIV, Viral
statutory limitations in its calculations Hepatitis and STD Prevention and issues influencing the ability of CDC
of the actual period for patent extension. Treatment. This meeting will be open to and HRSA to fulfill their missions of
In its application for patent extension, the public. Information about the CDC/ providing prevention and treatment
this applicant seeks 5 years of patent HRSA Advisory Committee on HIV, services; programmatic efforts to
term extension. Viral Hepatitis and STD Prevention and prevent and treat HIV, viral hepatitis,
Treatment and the agenda for this and other STDs; and support to CDC
III. Petitions and HRSA in their development of
meeting can be obtained by contacting
CDR Holly Berilla at (301) 443–9965 or responses to emerging health needs
Anyone with knowledge that any of
hberilla@hrsa.gov. related to HIV, viral hepatitis, and other
the dates as published are incorrect may
DATES: October 25, 2017, 9:00 a.m. to STDs.
submit either electronic or written
comments and, under 21 CFR 60.24, ask 5:30 p.m. (Eastern) and October 26, During the October 25 to 26, 2017,
for a redetermination (see DATES). 2017, 9:00 a.m. to 4:15 p.m. (Eastern). meeting, the CDC/HRSA Advisory
Furthermore, as specified in 21 CFR ADDRESSES: This meeting will be held in Committee on HIV, Viral Hepatitis and
60.30, any interested person may person and offer virtual access through STD Prevention and Treatment will
petition FDA for a determination teleconference and Adobe Connect. The discuss strategies to link, retain, and re-
regarding whether the applicant for address for the meeting is 5600 Fishers engage people living with HIV into the
extension acted with due diligence Lane, Pavilion, Rockville, Maryland Ryan White HIV/AIDS Program system
during the regulatory review period. To 20857. The conference call-in number is of care; HAB’s benchmarking and risk
meet its burden, the petition must (888) 469–0566 and passcode is adjustment initiatives; HRSA and CDC
6012320. The webinar link is https:// initiatives regarding congenital syphilis;
comply with all the requirements of 21
hrsa.connectsolutions.com/october_ and committee workgroup reports.
CFR 60.30, including but not limited to:
chac_meeting/. Agenda items are subject to change as
Must be timely (see DATES), must be
FOR FURTHER INFORMATION CONTACT: priorities dictate.
filed in accordance with 21 CFR 10.20,
Those requesting information regarding Members of the public will have the
must contain sufficient facts to merit an
the CDC/HRSA Advisory Committee on opportunity to provide comments. Oral
FDA investigation, and must certify that
HIV, Viral Hepatitis and STD Prevention comments will be honored in the order
a true and complete copy of the petition and Treatment should contact CDR
has been served upon the patent they are requested and may be limited
Holly Berilla, Senior Public Health as time allows. Requests to make oral
applicant. (See H. Rept. 857, part 1, 98th Analyst, Division of Policy and Data
Cong., 2d sess., pp. 41–42, 1984.) comments or provide written comments
(DPD), HIV/AIDS Bureau (HAB), HRSA, to the CDC/HRSA Advisory Committee
Petitions should be in the format in one of three ways: (1) Mail a request
specified in 21 CFR 10.30. on HIV, Viral Hepatitis and STD
to CDR Holly Berilla, Senior Public Prevention and Treatment should be
Submit petitions electronically to Health Analyst, HRSA/HAB/DPD, 5600 sent to CDR Holly Berilla, using the
https://www.regulations.gov at Docket Fishers Lane, 9N164C, Rockville,
contact information listed above, by
No. FDA–2013–S–0610. Submit written Maryland 20857; (2) call (301) 443–
October 11, 2017.
petitions (two copies are required) to the 9965; or (3) send an email to hberilla@
hrsa.gov. The building at 5600 Fishers Lane,
Dockets Management Staff (HFA–305),
SUPPLEMENTARY INFORMATION: The CDC/ Rockville, MD 20857, requires a security
Food and Drug Administration, 5630
HRSA Advisory Committee on HIV, screening on entry. To facilitate your
Fishers Lane, Rm. 1061, Rockville, MD
Viral Hepatitis and STD Prevention and access to the building please contact
20852.
Treatment was established under CDR Holly Berilla (contact information
mstockstill on DSK30JT082PROD with NOTICES

Dated: August 24, 2017. Section 222 of the Public Health Service provided above). Individuals who plan
Anna K. Abram, Act, [42 U.S.C. Section 217a], as to attend and need special assistance,
Deputy Commissioner for Policy, Planning, amended. such as sign language interpretation or
Legislation, and Analysis. The purpose of the CDC/HRSA other reasonable accommodations,
[FR Doc. 2017–18380 Filed 8–29–17; 8:45 am] Advisory Committee on HIV, Viral should notify CDR Holly Berilla (contact
BILLING CODE 4164–01–P
Hepatitis and STD Prevention and information provided above) at least 10
Treatment is to advise the Secretary of days prior to the meeting.

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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41277

Status: This advisory committee additional information for the meeting will DEPARTMENT OF HEALTH AND
meeting will be open to the public. be posted when available. HUMAN SERVICES
(Catalogue of Federal Domestic Assistance
Amy McNulty, Program Nos. 93.233, National Center for National Institutes of Health
Acting Director, Division of the Executive Sleep Disorders Research; 93.837, Heart and
Secretariat. Vascular Diseases Research; 93.838, Lung Center for Scientific Review; Notice of
[FR Doc. 2017–18426 Filed 8–29–17; 8:45 am] Diseases Research; 93.839, Blood Diseases Closed Meetings
and Resources Research, National Institutes
BILLING CODE 4165–15–P
of Health, HHS) Pursuant to section 10(d) of the
Dated: August 24, 2017. Federal Advisory Committee Act, as
DEPARTMENT OF HEALTH AND Jennifer S, Spaeth, amended, notice is hereby given of the
HUMAN SERVICES Director, Office of Federal Advisory
following meetings.
Committee Policy.
The meetings will be closed to the
National Institutes of Health public in accordance with the
[FR Doc. 2017–18340 Filed 8–29–17; 8:45 am]
provisions set forth in sections
BILLING CODE 4140–01–P
National Heart, Lung, and Blood 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Institute; Notice of Meeting as amended. The grant applications and
DEPARTMENT OF HEALTH AND the discussions could disclose
Pursuant to section 10(d) of the confidential trade secrets or commercial
Federal Advisory Committee Act, as HUMAN SERVICES
property such as patentable material,
amended, notice is hereby given of a National Institutes of Health and personal information concerning
meeting of the National Heart, Lung, individuals associated with the grant
and Blood Advisory Council. National Institute of Allergy And applications, the disclosure of which
The meeting will be open to the Infectious Diseases; Notice of Closed would constitute a clearly unwarranted
public as indicated below, with Meeting invasion of personal privacy.
attendance limited to space available.
Name of Committee: Center for Scientific
Individuals who plan to attend and Pursuant to section 10(d) of the Review, Special Emphasis Panel; PAR17–
need special assistance, such as sign Federal Advisory Committee Act, as 033: Integrative Research to Understand the
language interpretation or other amended, notice is hereby given of the Impact of Sex Differences on the Molecular
reasonable accommodations, should following meeting. Determinants of AD Risk and Responsiveness
notify the Contact Person listed below to Treatment.
The meeting will be closed to the Date: September 25, 2017.
in advance of the meeting. public in accordance with the Time: 11:00 a.m. to 5:00 p.m.
Name of Committee: National Heart, Lung, provisions set forth in sections Agenda: To review and evaluate grant
and Blood Advisory Council. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications.
Date: September 12, 2017. as amended. The contract proposals and Place: National Institutes of Health, 6701
Closed: 8:00 a.m. to 12:30 p.m. the discussions could disclose Rockledge Drive, Bethesda, MD 20892
Agenda: To review and evaluate grant (Virtual Meeting).
applications.
confidential trade secrets or commercial
Contact Person: Alexei Kondratyev, Ph.D.,
Open: 2:30 p.m. to 4:30 p.m. property such as patentable material, Scientific Review Officer, Center for
Agenda: To discuss program policies and and personal information concerning Scientific Review, National Institutes of
issues. individuals associated with the contract Health, 6701 Rockledge Drive, Room 5200,
Place: National Institutes of Health, proposals, the disclosure of which MSC 7846, Bethesda, MD 20892, 301–435–
Building 35A, Porter Building, Room 640, would constitute a clearly unwarranted 1785, kondratyevad@csr.nih.gov.
35A Convent Drive, Bethesda, MD 20892. invasion of personal privacy. Name of Committee: Center for Scientific
Contact Person: Laura K. Moen, Ph.D., Review, Special Emphasis Panel; PAR15–
Director, Division of Extramural Research Name of Committee: National Institute of
357: Understanding Alzheimer’s Disease in
Activities, National Heart, Lung, and Blood Allergy and Infectious Diseases Special
the Context of the Aging Brain.
Institute, National Institutes of Health, 6701 Emphasis Panel NIAID Peer Review Meeting,
Date: September 25, 2017.
Rockledge Drive, Room 7100, Bethesda, MD Date: September 27, 2017. Time: 11:00 a.m. to 5:00 p.m.
20892, 301–435–0260, moenl@mail.nih.gov. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant
This notice is being amended to reflect Agenda: To review and evaluate contract applications.
changes in open and closed sessions. proposals. Place: National Institutes of Health, 6701
Any interested person may file written Place: National Institutes of Health, 5601 Rockledge Drive, Bethesda, MD 20892
comments with the committee by forwarding Fishers Lane, Rockville, MD 20892 (Virtual Meeting).
the statement to the Contact Person listed on (Telephone Conference Call). Contact Person: Alexei Kondratyev, Ph.D.,
this notice. The statement should include the Contact Person: Kelly Y. Poe, Ph.D., Scientific Review Officer, Center for
name, address, telephone number and when Scientific Review Program, Division of Scientific Review, National Institutes of
applicable, the business or professional Extramural Activities, Room 3F40B, National Health, 6701 Rockledge Drive, Room 5200,
affiliation of the interested person. Institutes of Health, NIAID, 5601 Fishers MSC 7846, Bethesda, MD 20892, 301–435–
In the interest of security, NIH has Lane, MSC 9823, Bethesda, MD 20892–9823, 1785, kondratyevad@csr.nih.gov.
instituted stringent procedures for entrance (240) 669–5036,poeky@mail.nih.gov.
Name of Committee: Brain Disorders and
onto the NIH campus. All visitor vehicles, (Catalogue of Federal Domestic Assistance
Clinical Neuroscience Integrated Review
including taxicabs, hotel, and airport shuttles Program Nos. 93.855, Allergy, Immunology, Group; Pathophysiological Basis of Mental
will be inspected before being allowed on and Transplantation Research; 93.856, Disorders and Addictions Study Section.
campus. Visitors will be asked to show one Microbiology and Infectious Diseases Date: September 28–29, 2017.
mstockstill on DSK30JT082PROD with NOTICES

form of identification (for example, a Research, National Institutes of Health, HHS) Time: 8:00 a.m. to 5:00 p.m.
government-issued photo ID, driver’s license, Dated: August 24, 2017. Agenda: To review and evaluate grant
or passport) and to state the purpose of their Natasha M. Copeland, applications.
visit. Place: Wyndham Grand Chicago
Program Analyst, Office of Federal Advisory
Information is also available on the Riverfront, 71 East Wacker Drive, Chicago, IL
Committee Policy.
Institute’s/Center’s home page: 60601.
www.nhlbi.nih.gov/meetings/nhlbac/ [FR Doc. 2017–18337 Filed 8–29–17; 8:45 am] Contact Person: Boris P Sokolov, Ph.D.,
index.htm, where an agenda and any BILLING CODE 4140–01–P Scientific Review Officer, Center for

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Document Created: 2017-08-30 04:08:12
Document Modified: 2017-08-30 04:08:12

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		October 25, 2017, 9:00 a.m. to 5:30 p.m. (Eastern) and October 26, 2017, 9:00 a.m. to 4:15 p.m. (Eastern).
Contact		Those requesting information regarding the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment should contact CDR Holly Berilla, Senior Public Health Analyst, Division of Policy and Data (DPD), HIV/AIDS Bureau (HAB), HRSA, in one of three ways: (1) Mail a request to CDR Holly Berilla, Senior Public Health Analyst, HRSA/HAB/DPD, 5600 Fishers Lane, 9N164C, Rockville, Maryland 20857; (2) call (301) 443-9965; or (3) send an email to [email protected]
FR Citation		82 FR 41276

82 FR 41276 - CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 82, Issue 167 (August 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration