Announcement of Establishment of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 and Solicitation of Nominations for Membership; Correction, 21581-21582 [2016-08284]

Download as PDF Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for GAZYVA is 1,698 days. Of this time, 1,504 days occurred during the testing phase of the regulatory review period, while 194 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: March 11, 2009. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on March 11, 2009. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): April 22, 2013. FDA has verified the applicant’s claim that the biologics license application (BLA) for GAZYVA (BLA 125486) was initially submitted on April 22, 2013. 3. The date the application was approved: November 1, 2013. FDA has verified the applicant’s claim that BLA 125486 was approved on November 1, 2013. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 929, 946, or 484 days, respectively, of patent term extension. asabaliauskas on DSK3SPTVN1PROD with NOTICES regulatory review period and that the approval of GAZYVA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984). Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 [FR Doc. 2016–08338 Filed 4–11–16; 8:45 am] BILLING CODE 4164–01–P 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 OGA.RSVP@hhs.gov. 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 21581 Building, we will need to receive RSVPs for this event. Please send your full name and organization to OGA.RSVP@ hhs.gov. 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: OGA.RSVP@hhs.gov. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Establishment of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 and Solicitation of Nominations for Membership; Correction Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services. ACTION: Notice; correction. AGENCY: The U.S. Department of Health and Human Services published a notice in the Federal Register, dated March 17, 2016, to announce the establishment of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) and invites nominations for membership. This notice contained incorrect information. SUMMARY: FOR FURTHER INFORMATION CONTACT: Emmeline Ochiai, email address: HP2030@hhs.gov. Correction In the Federal Register, dated March 17, 2016, on page 14455, correct the Title to read: Announcement of Intent to Establish the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 and Solicitation of Nominations for Membership and correct the SUMMARY to read: SUMMARY: The U.S. Department of Health and Human Services (HHS) announces its intent E:\FR\FM\12APN1.SGM 12APN1 21582 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices to establish the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) and invites nominations for membership. Dated: April 5, 2016. Donald Wright, Deputy Assistant Secretary for Health, (Disease Prevention and Health Promotion). [FR Doc. 2016–08284 Filed 4–11–16; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency; Correction Department of Health and Human Services (HHS), Office of the Secretary. AGENCY: ACTION: Notice, correction. This document corrects one technical error that appeared in the final guidance published in the Federal Register on April 1, 2016 (81 OFR 18865), entitled ‘‘Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency.’’ SUMMARY: This correction is effective on April 12, 2016. DATES: Copy of the final guidance may be obtained at www.PHE.gov/ TemporaryReassignment. ADDRESSES: For additional information, please contact: Sally Phillips, RN, Ph.D., Deputy Assistant Secretary, Office of Policy and Planning, Office of the Assistant Secretary for Preparedness and Response, 200 Independence SW., Washington, DC 20004. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES Correction: In FR Doc. 16–07404, published on April 1, 2016, (81 FR 18865) make the following correction. On page 18865, in the second column, correct the Web site address to read: www.PHE.gov/TemporaryReassignment. Dated: April 6, 2016. Wilma Robinson, Deputy Executive Secretary to the Department, U.S. Department of Health and Human Services. [FR Doc. 2016–08289 Filed 4–11–16; 8:45 am] BILLING CODE 4150–37–P VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Program Project: Animal/Biological Resource Facilities. Date: April 20, 2016. Time: 11:30 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Serena Chu, Ph.D., Scientific Review Officer, BBBP IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3178, MSC 7848, Bethesda, MD 20892, 301–500– 5829, sechu@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Memory and Stress. Date: April 22, 2016. Time: 12:30 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892–7814, 301– 435–1787, borzanj@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846– 93.878, 93.892, 93.893, National Institutes of Health, HHS) PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Dated: April 5, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–08290 Filed 4–11–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Board on Medical Rehabilitation Research. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Advisory Board on Medical Rehabilitation Research. Date: May 2–3, 2016. Time: May 2, 2016, 9:00 a.m. to 5:00 p.m. Agenda: NICHD and NCMRR Director’s reports; NICHD training activities; Review of Cerebral Palsy workshop; Operationalizing NIH rehabilitation research plan. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Time: May 3, 2016, 8:30 a.m. to 12:00 p.m. Agenda: Common data elements in rehabilitation research; Promoting rehabilitation research grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Ralph M. Nitkin, Ph.D., Deputy Director, National Center for Medical Rehabilitation Research (NCMRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, 6100 Executive Boulevard, Room 2A03, Bethesda, MD 20892–7510, (301) 402– 4206, rn21e@nih.gov. Information is also available on the Institute’s/Center’s home page: http:// www.nichd.nih.gov/about/advisory/nabmrr/ Pages/index.aspx where the current roster and minutes from past meetings are posted. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21581-21582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Establishment of the Secretary's Advisory 
Committee on National Health Promotion and Disease Prevention 
Objectives for 2030 and Solicitation of Nominations for Membership; 
Correction

AGENCY: Office of Disease Prevention and Health Promotion, Office of 
the Assistant Secretary for Health, Office of the Secretary, U.S. 
Department of Health and Human Services.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Health and Human Services published a 
notice in the Federal Register, dated March 17, 2016, to announce the 
establishment of the Secretary's Advisory Committee on National Health 
Promotion and Disease Prevention Objectives for 2030 (Committee) and 
invites nominations for membership. This notice contained incorrect 
information.

FOR FURTHER INFORMATION CONTACT: Emmeline Ochiai, email address: 
HP2030@hhs.gov.

Correction

    In the Federal Register, dated March 17, 2016, on page 14455, 
correct the Title to read:

Announcement of Intent to Establish the Secretary's Advisory Committee 
on National Health Promotion and Disease Prevention Objectives for 2030 
and Solicitation of Nominations for Membership

and correct the Summary to read:

SUMMARY: The U.S. Department of Health and Human Services (HHS) 
announces its intent

[[Page 21582]]

to establish the Secretary's Advisory Committee on National Health 
Promotion and Disease Prevention Objectives for 2030 (Committee) and 
invites nominations for membership.

    Dated: April 5, 2016.
Donald Wright,
Deputy Assistant Secretary for Health, (Disease Prevention and Health 
Promotion).
[FR Doc. 2016-08284 Filed 4-11-16; 8:45 am]
 BILLING CODE 4150-32-P