81 FR 83853 - Solicitation of Written Comments on the Mid-Course Review Working Group Draft Report and Draft Recommendations for Consideration by the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 225 (November 22, 2016)

Page Range		83853-83854
FR Document		2016-28090

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (section 2105) (42 U.S. Code 300aa-5). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various Federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in her capacity as the Director of the National Vaccine Program on matters related to vaccine program responsibilities. Recognizing the changes in the immunization landscape, the ASH charged the NVAC to conduct a Mid-course review to evaluate the progress of the National Vaccine Plan and provide recommendations to optimize priority areas. In March 2016, the NVAC formed the Mid-Course Review Working Group. Through a series of conference calls, electronic communication, and public discussions during the NVAC meetings, the working group identified a number of draft recommendations for consideration by the NVAC. These recommendations serve as a useful tool in refining collective strategies for shaping the future of the U.S. immunization enterprise, both domestically and globally. The draft report and draft recommendations from the working group will inform NVAC deliberations as the NVAC finalizes their recommendations for transmittal to the ASH. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in February 2017 at the quarterly NVAC meeting.

Federal Register, Volume 81 Issue 225 (Tuesday, November 22, 2016)

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83853-83854]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the Mid-Course Review Working 
Group Draft Report and Draft Recommendations for Consideration by the 
National Vaccine Advisory Committee

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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

SUMMARY: The National Vaccine Advisory Committee (NVAC) was established 
in 1987 to comply with Title XXI of the Public Health Service Act (Pub. 
L. 99-660) (section 2105) (42 U.S. Code 300aa-5). Its purpose is to 
advise and make recommendations to the Director of the National Vaccine 
Program on matters related to program responsibilities. The Assistant 
Secretary for Health (ASH) has been designated by the Secretary of 
Health and Human Services (HHS) as the Director of the National Vaccine 
Program. The National Vaccine Program Office (NVPO) is located within 
the Office of the Assistant Secretary for Health (OASH), Office of the 
Secretary, U.S. Department of Health and Human Services (HHS). NVPO 
provides leadership and fosters collaboration among the various Federal 
agencies involved in vaccine and immunization activities. The NVPO also 
supports the National Vaccine Advisory Committee (NVAC). The NVAC 
advises and makes recommendations to the ASH in her capacity as the 
Director of the National Vaccine Program on matters related to vaccine 
program responsibilities.
    Recognizing the changes in the immunization landscape, the ASH 
charged the NVAC to conduct a Mid-course review to evaluate the 
progress of the National Vaccine Plan and provide recommendations to 
optimize priority areas. In March 2016, the NVAC formed the Mid-Course 
Review Working Group. Through a series of conference calls, electronic 
communication, and public discussions during the NVAC meetings, the 
working group identified a number of draft recommendations for 
consideration by the NVAC. These recommendations serve as a useful tool 
in refining collective strategies for shaping the future of the U.S. 
immunization enterprise, both domestically and globally. The draft 
report and draft recommendations from the working group will inform 
NVAC deliberations as the NVAC finalizes their recommendations for 
transmittal to the ASH.
    On behalf of NVAC, NVPO is soliciting public comment on the draft 
report and draft recommendations from a variety of stakeholders, 
including the general public, for consideration by the NVAC as they 
develop their final recommendations to the ASH. It is anticipated that 
the draft report and draft recommendations, as revised with 
consideration given to public comment and stakeholder input, will be 
presented to the NVAC for adoption in February 2017 at the quarterly 
NVAC meeting.

DATES: Comments for consideration by the NVAC should be received no 
later than 5 p.m. EDT on December 27, 2016.

ADDRESSES: 
     The draft report and draft recommendations are available 
on the Web at http://www.hhs.gov/nvpo/nvac/index.html.

[[Page 83854]]

     Electronic responses are preferred and may be addressed 
to: [email protected].
     Written responses should be addressed to: National Vaccine 
Program Office, U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Room 733G.3B, Washington, DC 20201, Attn: NVAC 
Mid-course Review c/o Anju Abraham.

FOR FURTHER INFORMATION CONTACT: Anju Abraham, MS, MPH, National 
Vaccine Program Office, Office of the Assistant Secretary for Health, 
Department of Health and Human Services; telephone 202-205-5641; email 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Public health represents a collaboration of multiple sectors in 
society working together to prevent disease and promote health. These 
concerted efforts include the tremendous impacts of the U.S. vaccine 
and immunization system, which represents one of the most significant 
public health achievements in the 20th century. Estimates suggest that 
routine childhood immunizations prevented 322 million illnesses and 
averted 732,000 premature deaths from vaccine-preventable illnesses in 
children born between 1994-2013, with an estimated societal cost-
savings of $1.38 trillion.
    The 2010 National Vaccine Plan provides a ten-year strategic 
direction for all U.S. vaccine and immunization related activities to 
create a robust and coordinated system to improve the health of 
Americans by achieving optimal prevention of infectious diseases 
through vaccination. The Department of Health and Human Services 
recognized the need to conduct an evaluation of the plan and 
subsequently charged the National Vaccine Advisory Committee with 
making recommendations that would address the progress of the 2010 
National Vaccine Plan.
    In March 2016, the NVAC formed a Mid-Course Review Working Group 
(MCRWG) to evaluate the status of progress on the goals of the National 
Vaccine Plan (the document can be found here: www.hhs.gov/nvpo/national-vaccine-plan/midcourse/index.html) and develop recommendations 
to the ASH. The MCRWG began their efforts by reviewing and assessing 
the findings from the National Vaccine Program's (NVPO) Mid-course 
Review to identify the opportunity areas. Then, the MCRWG shifted its 
focus to coordinate additional information collection from non-federal 
stakeholders to represent consumer groups and from federal stakeholders 
to further inform their findings and recommendations. Through a number 
of conference calls, electronic communication, and public discussions 
at the NVAC meetings, the working group identified a number of draft 
recommendations. These recommendations frame the five areas that 
represent opportunities to advance the National Vaccine Program over 
the remaining five years of the National Vaccine Plan. These five areas 
of opportunity include:
    (1) Strengthen health information and surveillance systems to 
track, analyze and visualize disease, immunization coverage, and safety 
data, both domestically and globally;
    (2) Foster and facilitate efforts to strengthen confidence in 
vaccines and the immunization system to increase coverage rates across 
the lifespan;
    (3) Eliminate financial and systems barriers for providers and 
consumers to facilitate access to routinely recommended vaccines;
    (4) Strengthen the science base for the development and licensure 
of vaccines;
    (5) Facilitate vaccine development.
    The NVAC draft report outlines the background and rationale for 
each of the opportunity areas and addresses the challenges, 
characteristics that constitute success, metrics to measure each area, 
and proposed metrics to be developed in the future. The conclusions and 
recommendations detail how the ASH can support HHS activities in these 
areas.

II. Request for Comment

    NVPO, on behalf of the NVAC Mid-course Review Working Group, 
requests input on the draft report and draft recommendations. In 
addition to general comments on the draft report and draft 
recommendations, NVPO is seeking input on characteristics of success, 
challenges, and metrics to achieve success in the five opportunity 
areas outlined in the report. Please limit your comments to six (6) 
pages.

III. Potential Responders

    HHS invites input from a broad range of stakeholders including 
individuals and organizations that have interests U.S. vaccine and 
immunization efforts and the role of HHS in advancing those efforts.
    Examples of potential responders include, but are not limited to, 
the following:

--General public;
--advocacy groups, non-profit organizations, and public interest 
organizations;
--academics, professional societies, and healthcare organizations;
--public health officials and immunization program managers;
--physician and non-physician providers that administer immunization 
services, including pharmacists; and
--representatives from the private sector.

    When responding, please self-identify with any of the above or 
other categories (include all that apply) and your name. Anonymous 
submissions will not be considered. Written submissions should not 
exceed six (6) pages. Please do not send proprietary, commercial, 
financial, business, confidential, trade secret, or personal 
information.

    Dated: November 10, 2016.
Bruce Gellin,
Executive Secretary, National Vaccine Advisory Committee, Deputy 
Assistant Secretary for Health, Director, National Vaccine Program 
Office.
[FR Doc. 2016-28090 Filed 11-21-16; 8:45 am]
 BILLING CODE 4150-44-P

Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 83853

Although only a portion of a regulatory 205494 was approved on August 19, Program on matters related to program
review period may count toward the 2014. responsibilities. The Assistant Secretary
actual amount of extension that the This determination of the regulatory for Health (ASH) has been designated by
Director of USPTO may award (for review period establishes the maximum the Secretary of Health and Human
example, half the testing phase must be potential length of a patent extension. Services (HHS) as the Director of the
subtracted as well as any time that may However, the USPTO applies several National Vaccine Program. The National
have occurred before the patent was statutory limitations in its calculations Vaccine Program Office (NVPO) is
issued), FDA’s determination of the of the actual period for patent extension. located within the Office of the
length of a regulatory review period for In its application for patent extension, Assistant Secretary for Health (OASH),
a human drug product will include all this applicant seeks 1,518 days of patent Office of the Secretary, U.S. Department
of the testing phase and approval phase term extension. of Health and Human Services (HHS).
as specified in 35 U.S.C. 156(g)(1)(B). NVPO provides leadership and fosters
FDA has approved for marketing the III. Petitions
collaboration among the various Federal
human drug product CERDELGA Anyone with knowledge that any of agencies involved in vaccine and
(eliglustat). CERDELGA is indicated for the dates as published are incorrect may immunization activities. The NVPO also
the long-term treatment of adult patients submit either electronic or written supports the National Vaccine Advisory
with Gaucher disease type 1 who are comments and ask for a redetermination Committee (NVAC). The NVAC advises
CYP2D6 extensive metabolizers, (see DATES). Furthermore, any interested and makes recommendations to the
intermediate metabolizers, or poor person may petition FDA for a ASH in her capacity as the Director of
metabolizers as detected by an FDA- determination regarding whether the the National Vaccine Program on
cleared test. Subsequent to this applicant for extension acted with due matters related to vaccine program
approval, the USPTO received a patent diligence during the regulatory review responsibilities.
term restoration application for period. To meet its burden, the petition Recognizing the changes in the
CERDELGA (U.S. Patent No. 7,196,205) must be timely (see DATES) and contain immunization landscape, the ASH
from Genzyme Corporation, and the sufficient facts to merit an FDA charged the NVAC to conduct a Mid-
USPTO requested FDA’s assistance in investigation. (See H. Rept. 857, part 1, course review to evaluate the progress of
determining this patent’s eligibility for 98th Cong., 2d sess., pp. 41–42, 1984.) the National Vaccine Plan and provide
patent term restoration. In a letter dated Petitions should be in the format recommendations to optimize priority
October 15, 2015, FDA advised the specified in 21 CFR 10.30. areas. In March 2016, the NVAC formed
USPTO that this human drug product Submit petitions electronically to
the Mid-Course Review Working Group.
had undergone a regulatory review https://www.regulations.gov at Docket
Through a series of conference calls,
period and that the approval of No. FDA–2013–S–0610. Submit written
electronic communication, and public
CERDELGA represented the first petitions (two copies are required) to the
discussions during the NVAC meetings,
permitted commercial marketing or use Division of Dockets Management (HFA–
the working group identified a number
of the product. Thereafter, the USPTO 305), Food and Drug Administration,
of draft recommendations for
requested that FDA determine the 5630 Fishers Lane, Rm. 1061, Rockville,
consideration by the NVAC. These
product’s regulatory review period. MD 20852.
recommendations serve as a useful tool
II. Determination of Regulatory Review Dated: November 16, 2016. in refining collective strategies for
Period Leslie Kux, shaping the future of the U.S.
FDA has determined that the Associate Commissioner for Policy. immunization enterprise, both
applicable regulatory review period for [FR Doc. 2016–28045 Filed 11–21–16; 8:45 am] domestically and globally. The draft
CERDELGA is 3,854 days. Of this time, BILLING CODE 4164–01–P report and draft recommendations from
3,520 days occurred during the testing the working group will inform NVAC
phase of the regulatory review period, deliberations as the NVAC finalizes
while 334 days occurred during the DEPARTMENT OF HEALTH AND their recommendations for transmittal to
approval phase. These periods of time HUMAN SERVICES the ASH.
were derived from the following dates: On behalf of NVAC, NVPO is
1. The date an exemption under Solicitation of Written Comments on soliciting public comment on the draft
section 505(i) of the Federal Food, Drug, the Mid-Course Review Working Group report and draft recommendations from
and Cosmetic Act (the FD&C Act) (21 Draft Report and Draft a variety of stakeholders, including the
U.S.C. 355(i)) became effective: Recommendations for Consideration general public, for consideration by the
February 1, 2004. FDA has verified the by the National Vaccine Advisory NVAC as they develop their final
applicant’s claim that the date the Committee recommendations to the ASH. It is
investigational new drug application AGENCY: National Vaccine Program anticipated that the draft report and
became effective was on February 1, Office, Office of the Assistant Secretary draft recommendations, as revised with
2004. for Health, Office of the Secretary, consideration given to public comment
2. The date the application was Department of Health and Human and stakeholder input, will be presented
initially submitted with respect to the Services. to the NVAC for adoption in February
human drug product under section ACTION: Notice. 2017 at the quarterly NVAC meeting.
505(b) of the FD&C Act: September 20, DATES: Comments for consideration by
SUMMARY: The National Vaccine
sradovich on DSK3GMQ082PROD with NOTICES

2013. FDA has verified the applicant’s the NVAC should be received no later
claim that the new drug application Advisory Committee (NVAC) was
than 5 p.m. EDT on December 27, 2016.
(NDA) for CERDELGA (NDA 205494) established in 1987 to comply with Title
was initially submitted on September XXI of the Public Health Service Act ADDRESSES:
20, 2013. (Pub. L. 99–660) (section 2105) (42 U.S. • The draft report and draft
3. The date the application was Code 300aa–5). Its purpose is to advise recommendations are available on the
approved: August 19, 2014. FDA has and make recommendations to the Web at http://www.hhs.gov/nvpo/nvac/
verified the applicant’s claim that NDA Director of the National Vaccine index.html.

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83854 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices

• Electronic responses are preferred non-federal stakeholders to represent —academics, professional societies, and
and may be addressed to: consumer groups and from federal healthcare organizations;
anju.abraham@hhs.gov. stakeholders to further inform their —public health officials and
• Written responses should be findings and recommendations. immunization program managers;
addressed to: National Vaccine Program Through a number of conference calls, —physician and non-physician
Office, U.S. Department of Health and electronic communication, and public providers that administer
Human Services, 200 Independence discussions at the NVAC meetings, the immunization services, including
Avenue SW., Room 733G.3B, working group identified a number of pharmacists; and
Washington, DC 20201, Attn: NVAC draft recommendations. These —representatives from the private
Mid-course Review c/o Anju Abraham. recommendations frame the five areas sector.
FOR FURTHER INFORMATION CONTACT: that represent opportunities to advance
Anju Abraham, MS, MPH, National the National Vaccine Program over the When responding, please self-identify
Vaccine Program Office, Office of the remaining five years of the National with any of the above or other categories
Assistant Secretary for Health, Vaccine Plan. These five areas of (include all that apply) and your name.
Department of Health and Human opportunity include: Anonymous submissions will not be
Services; telephone 202–205–5641; (1) Strengthen health information and considered. Written submissions should
email anju.abraham@hhs.gov. surveillance systems to track, analyze not exceed six (6) pages. Please do not
and visualize disease, immunization send proprietary, commercial, financial,
SUPPLEMENTARY INFORMATION:
coverage, and safety data, both business, confidential, trade secret, or
I. Background domestically and globally; personal information.
Public health represents a (2) Foster and facilitate efforts to Dated: November 10, 2016.
collaboration of multiple sectors in strengthen confidence in vaccines and Bruce Gellin,
society working together to prevent the immunization system to increase
Executive Secretary, National Vaccine
disease and promote health. These coverage rates across the lifespan; Advisory Committee, Deputy Assistant
(3) Eliminate financial and systems Secretary for Health, Director, National
concerted efforts include the
barriers for providers and consumers to Vaccine Program Office.
tremendous impacts of the U.S. vaccine
facilitate access to routinely
and immunization system, which [FR Doc. 2016–28090 Filed 11–21–16; 8:45 am]
recommended vaccines;
represents one of the most significant BILLING CODE 4150–44–P
(4) Strengthen the science base for the
public health achievements in the 20th
development and licensure of vaccines;
century. Estimates suggest that routine (5) Facilitate vaccine development.
childhood immunizations prevented DEPARTMENT OF HEALTH AND
The NVAC draft report outlines the
322 million illnesses and averted HUMAN SERVICES
background and rationale for each of the
732,000 premature deaths from vaccine- opportunity areas and addresses the
preventable illnesses in children born National Institutes of Health
challenges, characteristics that
between 1994–2013, with an estimated constitute success, metrics to measure National Cancer Institute; Notice of
societal cost-savings of $1.38 trillion. each area, and proposed metrics to be Charter Renewal
The 2010 National Vaccine Plan developed in the future. The
provides a ten-year strategic direction conclusions and recommendations In accordance with Title 41 of the
for all U.S. vaccine and immunization detail how the ASH can support HHS U.S. Code of Federal Regulations,
related activities to create a robust and activities in these areas. Section 102–3.65(a), notice is hereby
coordinated system to improve the given that the Charter for the National
health of Americans by achieving II. Request for Comment Cancer Institute Council of Research
optimal prevention of infectious NVPO, on behalf of the NVAC Mid- Advocates was renewed for an
diseases through vaccination. The course Review Working Group, requests additional two-year period on August
Department of Health and Human input on the draft report and draft 17, 2016.
Services recognized the need to conduct recommendations. In addition to general It is determined that the National
an evaluation of the plan and comments on the draft report and draft Cancer Institute Council of Research
subsequently charged the National recommendations, NVPO is seeking Advocates is in the public interest in
Vaccine Advisory Committee with input on characteristics of success, connection with the performance of
making recommendations that would challenges, and metrics to achieve duties imposed on the National Cancer
address the progress of the 2010 success in the five opportunity areas Institute and National Institutes of
National Vaccine Plan. outlined in the report. Please limit your Health by law, and that these duties can
In March 2016, the NVAC formed a comments to six (6) pages. best be performed through the advice
Mid-Course Review Working Group and counsel of this group.
(MCRWG) to evaluate the status of III. Potential Responders
Inquiries may be directed to Jennifer
progress on the goals of the National HHS invites input from a broad range Spaeth, Director, Office of Federal,
Vaccine Plan (the document can be of stakeholders including individuals Advisory Committee Policy, Office of
found here: www.hhs.gov/nvpo/ and organizations that have interests the Director, National Institutes of
national-vaccine-plan/midcourse/ U.S. vaccine and immunization efforts Health, 6701 Democracy Boulevard,
index.html) and develop and the role of HHS in advancing those Suite 1000, Bethesda, Maryland 20892
recommendations to the ASH. The efforts.
sradovich on DSK3GMQ082PROD with NOTICES

(Mail code 4875), Telephone (301) 496–
MCRWG began their efforts by Examples of potential responders 2123, or spaethj@od.nih.gov.
reviewing and assessing the findings include, but are not limited to, the
from the National Vaccine Program’s following: Jennifer S. Spaeth,
(NVPO) Mid-course Review to identify —General public; Director, Office of Federal Advisory
the opportunity areas. Then, the —advocacy groups, non-profit Committee Policy.
MCRWG shifted its focus to coordinate organizations, and public interest [FR Doc. 2016–28041 Filed 11–21–16; 8:45 am]
additional information collection from organizations; BILLING CODE 4140–01–P

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Document Created: 2018-02-14 08:29:37
Document Modified: 2018-02-14 08:29:37

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.
Dates		Comments for consideration by the NVAC should be received no later than 5 p.m. EDT on December 27, 2016.
Contact		Anju Abraham, MS, MPH, National Vaccine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services; telephone 202-205-5641; email [email protected]
FR Citation		81 FR 83853