81 FR 21581 - Office of Global Affairs: Stakeholder Listening Session in Preparation for the 69th World Health Assembly

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 70 (April 12, 2016)

Page Range		21581-21581
FR Document		2016-08287

Federal Register, Volume 81 Issue 70 (Tuesday, April 12, 2016)

[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Page 21581]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of Global Affairs: Stakeholder Listening Session in 
Preparation for the 69th World Health Assembly

    Time and date: May 6th, 2016, 10:30 a.m.-12:00 Noon EST.
    Place: Hubert H. Humphrey Building, Room 505A, 200 Independence 
Ave. SW., Washington, District of Columbia 20201.
    Status: Open, but requiring RSVP to [email protected].
    Purpose: The U.S. Department of Health and Human Services (HHS)--
charged with leading the U.S. delegation to the 69th World Health 
Assembly--will hold an informal Stakeholder Listening Session on 
Friday, May 6, 10:30 a.m.-12:00 noon, in Conference Room 505A of the 
Hubert H. Humphrey Building, 200 Independence Ave. S.W., Washington, DC 
20201.
    The Stakeholder Listening Session will help the HHS Office of 
Global Affairs prepare the U.S. delegation for the World Health 
Assembly by taking full advantage of the knowledge, ideas, feedback, 
and suggestions from all communities interested in and affected by 
agenda items to be discussed at the 69th World Health Assembly. Your 
input will contribute to U.S. positions as we negotiate with our 
international colleagues at the World Health Assembly these important 
health topics.
    The listening session will be organized by agenda item, and 
participation is welcome from all individuals, particularly members of 
stakeholder communities, including:
     Public health and advocacy groups;
     State, local, and Tribal groups;
     Private industry;
     Minority health organizations; and
     Academic and scientific organizations.
    All agenda items to be discussed at the 69th World Health Assembly 
can be found at this Web site: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_1-en.pdf.
    RSVP: Due to security restrictions for entry into the HHS Hubert H. 
Humphrey Building, we will need to receive RSVPs for this event. Please 
send your full name and organization to [email protected]. If you are 
not a U.S. citizen, please note this in the subject line of your RSVP, 
and our office will contact you to gain additional biographical 
information for your clearance. Please RSVP no later than Wednesday, 
April 27, 2016.
    Written comments are welcome and encouraged, even if you are 
planning on attending in person. Please send these to the email 
address: [email protected].
    We look forward to hearing your comments relative to the 69th World 
Health Assembly agenda items.

    Dated: March 14, 2016.
Jimmy Kolker,
Assistant Secretary for Global Affairs.
[FR Doc. 2016-08287 Filed 4-11-16; 8:45 am]
 BILLING CODE 4150-38-P

Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21581

regulatory review period and that the No. FDA–2013–S–0610. Submit written Building, we will need to receive RSVPs
approval of GAZYVA represented the petitions (two copies are required) to the for this event. Please send your full
first permitted commercial marketing or Division of Dockets Management (HFA– name and organization to OGA.RSVP@
use of the product. Thereafter, the 305), Food and Drug Administration, hhs.gov. If you are not a U.S. citizen,
USPTO requested that FDA determine 5630 Fishers Lane, Rm. 1061, Rockville, please note this in the subject line of
the product’s regulatory review period. MD 20852. your RSVP, and our office will contact
Dated: April 6, 2016. you to gain additional biographical
II. Determination of Regulatory Review
Leslie Kux,
information for your clearance. Please
Period
RSVP no later than Wednesday, April
FDA has determined that the Associate Commissioner for Policy.
27, 2016.
applicable regulatory review period for [FR Doc. 2016–08338 Filed 4–11–16; 8:45 am]
Written comments are welcome and
GAZYVA is 1,698 days. Of this time, BILLING CODE 4164–01–P encouraged, even if you are planning on
1,504 days occurred during the testing attending in person. Please send these to
phase of the regulatory review period, the email address: OGA.RSVP@hhs.gov.
while 194 days occurred during the DEPARTMENT OF HEALTH AND We look forward to hearing your
approval phase. These periods of time HUMAN SERVICES comments relative to the 69th World
were derived from the following dates: Health Assembly agenda items.
1. The date an exemption under Office of Global Affairs: Stakeholder
Listening Session in Preparation for Dated: March 14, 2016.
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)) the 69th World Health Assembly Jimmy Kolker,
became effective: March 11, 2009. FDA Assistant Secretary for Global Affairs.
Time and date: May 6th, 2016, 10:30
has verified the applicant’s claim that a.m.–12:00 Noon EST. [FR Doc. 2016–08287 Filed 4–11–16; 8:45 am]
the date the investigational new drug Place: Hubert H. Humphrey Building, BILLING CODE 4150–38–P
application became effective was on Room 505A, 200 Independence Ave.
March 11, 2009. SW., Washington, District of Columbia
2. The date the application was 20201. DEPARTMENT OF HEALTH AND
initially submitted with respect to the Status: Open, but requiring RSVP to HUMAN SERVICES
human biological product under section OGA.RSVP@hhs.gov.
351 of the Public Health Service Act (42 Purpose: The U.S. Department of Announcement of Establishment of the
U.S.C. 262): April 22, 2013. FDA has Health and Human Services (HHS)— Secretary’s Advisory Committee on
verified the applicant’s claim that the charged with leading the U.S. delegation National Health Promotion and Disease
biologics license application (BLA) for to the 69th World Health Assembly— Prevention Objectives for 2030 and
GAZYVA (BLA 125486) was initially will hold an informal Stakeholder Solicitation of Nominations for
submitted on April 22, 2013. Listening Session on Friday, May 6, Membership; Correction
3. The date the application was 10:30 a.m.–12:00 noon, in Conference AGENCY: Office of Disease Prevention
approved: November 1, 2013. FDA has Room 505A of the Hubert H. Humphrey and Health Promotion, Office of the
verified the applicant’s claim that BLA Building, 200 Independence Ave. S.W., Assistant Secretary for Health, Office of
125486 was approved on November 1, Washington, DC 20201. the Secretary, U.S. Department of Health
2013. The Stakeholder Listening Session and Human Services.
This determination of the regulatory will help the HHS Office of Global ACTION: Notice; correction.
review period establishes the maximum Affairs prepare the U.S. delegation for
potential length of a patent extension. the World Health Assembly by taking SUMMARY: The U.S. Department of
However, the USPTO applies several full advantage of the knowledge, ideas, Health and Human Services published a
statutory limitations in its calculations feedback, and suggestions from all notice in the Federal Register, dated
of the actual period for patent extension. communities interested in and affected March 17, 2016, to announce the
In its applications for patent extension, by agenda items to be discussed at the establishment of the Secretary’s
this applicant seeks 929, 946, or 484 69th World Health Assembly. Your Advisory Committee on National Health
days, respectively, of patent term input will contribute to U.S. positions Promotion and Disease Prevention
extension. as we negotiate with our international Objectives for 2030 (Committee) and
III. Petitions colleagues at the World Health invites nominations for membership.
Assembly these important health topics. This notice contained incorrect
Anyone with knowledge that any of The listening session will be information.
the dates as published are incorrect may organized by agenda item, and
submit either electronic or written FOR FURTHER INFORMATION CONTACT:
participation is welcome from all
comments and ask for a redetermination individuals, particularly members of Emmeline Ochiai, email address:
(see DATES). Furthermore, any interested stakeholder communities, including: HP2030@hhs.gov.
person may petition FDA for a • Public health and advocacy groups; Correction
determination regarding whether the • State, local, and Tribal groups;
applicant for extension acted with due • Private industry; In the Federal Register, dated March
diligence during the regulatory review • Minority health organizations; and 17, 2016, on page 14455, correct the
period. To meet its burden, the petition • Academic and scientific Title to read:
asabaliauskas on DSK3SPTVN1PROD with NOTICES

must be timely (see DATES) and contain organizations. Announcement of Intent to Establish the
sufficient facts to merit an FDA All agenda items to be discussed at Secretary’s Advisory Committee on National
investigation (See H. Rept. 857, part 1, the 69th World Health Assembly can be Health Promotion and Disease Prevention
98th Cong., 2d sess., pp. 41–42, 1984). found at this Web site: http:// Objectives for 2030 and Solicitation of
Nominations for Membership
Petitions should be in the format apps.who.int/gb/ebwha/pdf_files/
specified in 21 CFR 10.30. WHA69/A69_1-en.pdf. and correct the SUMMARY to read:
Submit petitions electronically to RSVP: Due to security restrictions for SUMMARY: The U.S. Department of Health and
http://www.regulations.gov at Docket entry into the HHS Hubert H. Humphrey Human Services (HHS) announces its intent

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Document Created: 2016-04-12 00:47:11
Document Modified: 2016-04-12 00:47:11

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
Dates		May 6th, 2016, 10:30 a.m.-12:00 Noon EST.
FR Citation		81 FR 21581