80 FR 54529 - Request for Comments On World Health Organization Pandemic Influenza Preparedness Framework
DEPARTMENT OF COMMERCE
International Trade Administration Federal Register Volume 80, Issue 175 (September 10, 2015)
International Trade Administration
Federal Register Volume 80, Issue 175 (September 10, 2015)
| Page Range | 54529-54530 | |
| FR Document | 2015-22730 |
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)] [Notices] [Pages 54529-54530] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22730] ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE International Trade Administration Request for Comments On World Health Organization Pandemic Influenza Preparedness Framework AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice and Request for Comments. ----------------------------------------------------------------------- SUMMARY: The International Trade Administration invites submission of comments from the public and relevant industries on influenza surveillance and response, related to the implementation of the World Health Organization (WHO) Pandemic Influenza Preparedness Framework (PIP-FW) (http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf). Comments will be used to support the five-year review of the WHO PIP-FW in 2016. DATES: Written comments must be submitted on or before October 7, 2015. Comments should be no more than 15 pages. Business-confidential information should be clearly identified as such. ADDRESSES: Submissions should be made via the Internet at www.regulations.gov docket number ITA-2015-0003. For alternatives to on-line submissions please contact Jennifer Boger at (202) 482-3360. The public is strongly encouraged to file submissions electronically rather than by facsimile or mail. FOR FURTHER INFORMATION CONTACT: Questions regarding the submission of comments should be directed to Jennifer Boger at (202) 482-3360, [email protected], or Bijou Mgbojikwe at (202) 482-1722, [email protected]. SUPPLEMENTARY INFORMATION: Background: In 2007, the Sixtieth World Health Assembly passed a resolution calling on the Director-General to convene an intergovernmental meeting to develop mechanisms to ensure the continued sharing of potential pandemic influenza viruses, and the fair and equitable sharing of benefits arising from such sample sharing. For four years, WHO member states met as an Intergovernmental Mechanism, as well as informally, to negotiate the Pandemic Influenza Preparedness Framework (PIP-FW). The PIP-FW came into effect on May 24, 2011 when it was unanimously adopted by the Sixty-fourth World Health Assembly. The key goals of PIP are to improve and strengthen global influenza pandemic preparedness by: (1) Ensuring the global sharing of influenza viruses with human pandemic potential for continuous global monitoring and assessment of risks, and for the development of safe and effective countermeasures. The PIP-FW provides a transparent mechanism for sharing virus samples, based on two Standard Material Transfer Agreements (SMTAs) that specify the conditions for samples passed within and outside of the Global Influenza Surveillance and Response System (GISRS), and a traceability mechanism to monitor the movement of samples. (2) Increasing countries' access to vaccines and other pandemic related resources. Two innovative and complementary benefit-sharing mechanisms pool monetary and in-kind contributions from entities that use the GISRS to enhance pandemic influenza preparedness and response capacity for countries in need and at risk of pandemic influenza: The annual partnership contribution and the SMTA-2. At the core of the PIP-FW is a robust Global Influenza Surveillance and Response System (GISRS, previously called the Global Influenza Surveillance Network or GISN). Section 7.4.2 of the PIP-FW provides that: ``The Framework and its Annexes will be reviewed by 2016 with a view to proposing revisions reflecting development as appropriate, to the World Health Assembly in 2017, through the Executive Board.'' It is in anticipation of the 2016 review that the U.S. Department of Commerce seeks comments on the following points: (1) Experiences, best practices, opportunities, and challenges in advancing the PIP-FW over the past five years. (2) Experiences relating to the status and process of concluding Standard Material Transfer Agreements (SMTA2). (3) Use of partnership contributions and WHO efforts to strengthen the GISRS and overall global preparedness and response capability/ capacity. (4) How changing technology has impacted or has the ability to impact the existing PIP-FW. (5) Other matters related to prevention, planning and response whose resolution will be integral for the effective operation of a global influenza pandemic response. The facts and information obtained from written submissions will be used to inform the participation of the U.S. Department of Commerce in the interagency process to prepare for United States participation for the five- [[Page 54530]] year 2016 review of the PIP-FW. Upon receipt of the written submission, representatives from the U.S. Department of Commerce will consider them and share them, as needed, with other interested U.S. Government agencies and departments engaging in the five-year review process. The Department of Commerce invites comments from civil society organizations as well as pharmaceutical and medical technology industries and other interested members of the public on a number of issues regarding pandemic influenza preparedness and response. Entities making submissions may be contacted for further information or explanation and, in some cases, meetings with submitters may be requested. Dated: September 3, 2015. Jennifer Boger, Health Team Director, Office of Health and Information Technologies. [FR Doc. 2015-22730 Filed 9-9-15; 8:45 am] BILLING CODE 3510-DR-P
![Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices 54529
responsibility, under 19 CFR DEPARTMENT OF COMMERCE The key goals of PIP are to improve
351.402(f)(2), to file a certificate and strengthen global influenza
regarding the reimbursement of International Trade Administration pandemic preparedness by:
antidumping duties prior to liquidation (1) Ensuring the global sharing of
of the relevant entries during this Request for Comments On World influenza viruses with human pandemic
review period. Failure to comply with Health Organization Pandemic potential for continuous global
this requirement could result in the Influenza Preparedness Framework monitoring and assessment of risks, and
Secretary’s presumption that for the development of safe and effective
AGENCY:International Trade countermeasures. The PIP–FW provides
reimbursement of antidumping duties
Administration, U.S. Department of a transparent mechanism for sharing
occurred and the subsequent assessment
Commerce. virus samples, based on two Standard
of double antidumping duties.
Notice and Request for
ACTION: Material Transfer Agreements (SMTAs)
Administrative Protective Order Comments. that specify the conditions for samples
In accordance with 19 CFR passed within and outside of the Global
351.305(a)(3), this notice also serves as SUMMARY: The International Trade Influenza Surveillance and Response
a reminder to parties subject to Administration invites submission of System (GISRS), and a traceability
administrative protective order (APO) of comments from the public and relevant mechanism to monitor the movement of
their responsibility concerning the industries on influenza surveillance and samples.
return or destruction of proprietary response, related to the implementation (2) Increasing countries’ access to
information disclosed under the APO, of the World Health Organization vaccines and other pandemic related
which continues to govern business (WHO) Pandemic Influenza resources. Two innovative and
proprietary information in this segment Preparedness Framework (PIP–FW) complementary benefit-sharing
of the proceeding. Timely written (http://apps.who.int/gb/ebwha/pdf_ mechanisms pool monetary and in-kind
notification of the return or destruction files/WHA64/A64_8-en.pdf). Comments contributions from entities that use the
of APO materials or conversion to will be used to support the five-year GISRS to enhance pandemic influenza
judicial protective order is hereby review of the WHO PIP–FW in 2016. preparedness and response capacity for
requested. Failure to comply with the DATES: Written comments must be countries in need and at risk of
regulations and terms of an APO is a submitted on or before October 7, 2015. pandemic influenza: The annual
violation subject to sanction. Comments should be no more than 15 partnership contribution and the
We are issuing and publishing this pages. Business-confidential SMTA–2.
notice in accordance with sections information should be clearly identified At the core of the PIP–FW is a robust
751(a)(1) and 777(i) of the Act and 19 as such. Global Influenza Surveillance and
CFR 351.213(h). Response System (GISRS, previously
ADDRESSES: Submissions should be called the Global Influenza Surveillance
Dated: September 2, 2015. made via the Internet at
Paul Piquado,
Network or GISN). Section 7.4.2 of the
www.regulations.gov docket number PIP–FW provides that: ‘‘The Framework
Assistant Secretary for Enforcement and ITA–2015–0003. For alternatives to on-
Compliance.
and its Annexes will be reviewed by
line submissions please contact Jennifer 2016 with a view to proposing revisions
Appendix—List of Topics Discussed in Boger at (202) 482–3360. The public is reflecting development as appropriate,
the Issues and Decision Memorandum strongly encouraged to file submissions to the World Health Assembly in 2017,
electronically rather than by facsimile or through the Executive Board.’’ It is in
Summary mail.
Background anticipation of the 2016 review that the
Scope of the Order FOR FURTHER INFORMATION CONTACT: U.S. Department of Commerce seeks
Discussion of the Issues Questions regarding the submission of comments on the following points:
Comment 1: Legal Authority to Consider an comments should be directed to Jennifer (1) Experiences, best practices,
Alternative Comparison Method in an Boger at (202) 482–3360, opportunities, and challenges in
Administrative Review advancing the PIP–FW over the past five
Jennifer.Boger@trade.gov, or Bijou
Comment 2: Withdrawal of the Regulatory years.
Provisions Governing Targeted Dumping Mgbojikwe at (202) 482–1722,
Bijou.Mgbojikwe@trade.gov. (2) Experiences relating to the status
in LTFV Investigations
Comment 3: Differential Pricing Analysis and process of concluding Standard
SUPPLEMENTARY INFORMATION:
and the Administrative Procedures Act Material Transfer Agreements (SMTA2).
Background: In 2007, the Sixtieth (3) Use of partnership contributions
Comment 4: Differential Pricing Analysis:
Identification of a Pattern of Prices that World Health Assembly passed a and WHO efforts to strengthen the
Differ Significantly resolution calling on the Director- GISRS and overall global preparedness
Comment 5: Differential Pricing Analysis: General to convene an and response capability/capacity.
Whether the Average-to-Average (A-to-A) intergovernmental meeting to develop (4) How changing technology has
Method Can Account for Such mechanisms to ensure the continued impacted or has the ability to impact the
Differences sharing of potential pandemic influenza existing PIP–FW.
Comment 6: Differential Pricing Analysis: viruses, and the fair and equitable (5) Other matters related to
The Impact of ‘‘Zeroing’’
sharing of benefits arising from such prevention, planning and response
Comment 7: Differential Pricing Analysis:
Thresholds in the ‘‘Ratio Test’’ sample sharing. For four years, WHO whose resolution will be integral for the
mstockstill on DSK4VPTVN1PROD with NOTICES
Comment 8: Other Arguments Related to member states met as an effective operation of a global influenza
Differential Pricing Analysis Intergovernmental Mechanism, as well pandemic response.
Comment 9: Whether to Include Certain as informally, to negotiate the Pandemic The facts and information obtained
Costs Incurred by KR Enterprises in Influenza Preparedness Framework from written submissions will be used
Falcon’s Reported Cost of Manufacturing (PIP–FW). The PIP–FW came into effect to inform the participation of the U.S.
Recommendation on May 24, 2011 when it was Department of Commerce in the
[FR Doc. 2015–22869 Filed 9–9–15; 8:45 am] unanimously adopted by the Sixty- interagency process to prepare for
BILLING CODE 3510–DS–P fourth World Health Assembly. United States participation for the five-
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![54530 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
year 2016 review of the PIP–FW. Upon SUPPLEMENTARY INFORMATION: U.S.C. 278k, as implemented in 15 CFR
receipt of the written submission, part 290.
I. Abstract
representatives from the U.S.
Department of Commerce will consider The National Institute of Standards II. Method of Collection
them and share them, as needed, with and Technology’s (NIST) Hollings Electronically via www.grants.gov.
other interested U.S. Government Manufacturing Extension Partnership
agencies and departments engaging in (MEP) works with small and medium- III. Data
the five-year review process. sized U.S. manufacturers to help them
The Department of Commerce invites create and retain jobs, increase profits, OMB Control Number: 0693–0056.
comments from civil society and save time and money. The Form Number(s): None.
organizations as well as pharmaceutical nationwide network provides a variety Type of Review: Regular Revision of a
and medical technology industries and of services, from innovation strategies to currently approved information
other interested members of the public process improvements to sustainable
on a number of issues regarding collection.
manufacturing, supply chain and
pandemic influenza preparedness and technology acceleration services. MEP Affected Public: U.S.-based nonprofit
response. Entities making submissions centers also work with partners at the institution or organization. Nonprofit
may be contacted for further State and Federal levels on programs institutions include public and private
information or explanation and, in some that put manufacturers in position to nonprofit organizations, nonprofit or
cases, meetings with submitters may be develop new customers, expand into State colleges and universities, public or
requested. new markets and create new products. nonprofit community and technical
Dated: September 3, 2015. As a program of the U.S. Department colleges, and State, local or Tribal
Jennifer Boger, of Commerce, MEP offers a range of governments.
Health Team Director, Office of Health and effective resources to help Estimated Number of Respondents:
Information Technologies. manufacturers identify opportunities 24.
[FR Doc. 2015–22730 Filed 9–9–15; 8:45 am] that will accelerate and strengthen their
growth and competitiveness in the Estimated Time per Response: 112
BILLING CODE 3510–DR–P
global marketplace. hrs.
MEP is a nationwide network of more Estimated Total Annual Burden
DEPARTMENT OF COMMERCE than 1,200 technical experts—located in Hours: 2,688 hours.
every State—serving as trusted business Estimated Total Annual Cost to
National Institute of Standards and advisors focused on transforming U.S.
Technology Public: 0.
manufacturers to compete globally,
supporting supply chain integration, IV. Request for Comments
Proposed Information Collection; and providing access to technology for
Comment Request; Hollings improved productivity. MEP is built Comments are invited on: (a) Whether
Manufacturing Extension Partnership the proposed collection of information
around manufacturing extension centers
(HMEP) Program Application is necessary for the proper performance
locally positioned throughout the 50
Requirements of the functions of the agency, including
States and Puerto Rico. MEP Centers are
AGENCY: NIST, Commerce. a diverse network of State, non-profit whether the information shall have
ACTION: Notice. university-based, and other non-profit practical utility; (b) the accuracy of the
organizations, offering products and agency’s estimate of the burden
SUMMARY: The Department of services that address the critical needs (including hours and cost) of the
Commerce, as part of its continuing of their local manufacturers. proposed collection of information; (c)
effort to reduce paperwork and Each MEP Center works directly with ways to enhance the quality, utility, and
respondent burden, invites the general area manufacturers to provide expertise clarity of the information to be
public and other Federal agencies to and services tailored to their most collected; and (d) ways to minimize the
take this opportunity to comment on critical needs, ranging from process burden of the collection of information
proposed and/or continuing information improvement and workforce on respondents, including through the
collections, as required by the development to business practices and use of automated collection techniques
Paperwork Reduction Act of 1995. technology transfer. Additionally, MEP or other forms of information
DATES: Written comments must be Centers connect manufacturers with technology.
submitted on or before November 9, government and trade associations,
2015. universities and research laboratories, Comments submitted in response to
and a host of other public and private this notice will be summarized and/or
ADDRESSES: Direct all written comments
to Jennifer Jessup, Departmental resources to help them realize included in the request for OMB
Paperwork Clearance Officer, individual business goals. approval of this information collection;
Department of Commerce, Room 6616, Through local and national resources, they also will become a matter of public
14th and Constitution Avenue NW., MEP Centers have helped thousands of record.
Washington, DC 20230 (or via the manufacturers reinvent themselves, Dated: September 4, 2015.
Internet at JJessup@doc.gov). increase profits, create jobs and Glenna Mickelson,
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: establish a foundation for long-term
Management Analyst, Office of the Chief
Requests for additional information or business growth and productivity. Information Officer.
copies of the information collection This request is for the information [FR Doc. 2015–22788 Filed 9–9–15; 8:45 am]
instrument and instructions should be collection requirements associated with
BILLING CODE 3510–13–P
directed to Diane Henderson, submission of proposals for NIST MEP
Manufacturing Extension Partnership, funding. The intent of the collection is
100 Bureau Drive, Mail Stop 4800, 301– to meet statutory requirements for NIST
975–5105, mepffo@nist.gov. MEP, as well as compliance with 15
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Document Created: 2015-12-15 10:03:57
Document Modified: 2015-12-15 10:03:57
| 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 and Request for Comments. | |
| Dates | Written comments must be submitted on or before October 7, 2015. Comments should be no more than 15 pages. Business-confidential information should be clearly identified as such. | |
| Contact | Questions regarding the submission of comments should be directed to Jennifer Boger at (202) 482-3360, [email protected], or Bijou Mgbojikwe at (202) 482-1722, [email protected] | |
| FR Citation | 80 FR 54529 |
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