[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58947-58948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20525]



[[Page 58947]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the Maternal Immunizations 
Working Group Phase II's Draft Report and Draft Recommendations for 
Overcoming Barriers and Identifying Opportunities for Developing 
Maternal Immunizations 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.

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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) (Sec.  2105) (42 U.S. Code Section 300aa-5). Its purpose is 
to advise and make recommendations to the Director of the National 
Vaccine Program on matters related to the program's 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). The NVPO provides leadership and fosters collaboration among the 
various federal agencies involved in vaccine and immunization 
activities. The NVPO also provides management and support services for 
the National Vaccine Advisory Committee (NVAC). The NVAC advises and 
makes recommendations to the ASH in his/her capacity as the Director of 
the National Vaccine Program on matters related to the program's 
responsibilities.
    Recognizing the importance and impact of maternal immunizations on 
public health, the ASH charged the NVAC in June 2012 with reviewing the 
state of maternal immunizations and existing best practices to identify 
programmatic gaps and/or barriers to the implementation of current 
recommendations regarding maternal immunization. The NVAC established 
the Maternal Immunization Working Group (MIWG) in August 2012 to 
conduct these assessments and provide recommendations for overcoming 
any identified barriers.
    Through a series of teleconferences, electronic communications, and 
public discussions during the NVAC meetings, the working group 
identified a number of draft recommendations for consideration by the 
NVAC. These recommendations represent opportunities for developing and 
licensing new vaccines for pregnant women. 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 September 2016 at the quarterly 
NVAC meeting.

DATES: Comments for consideration by the NVAC should be received no 
later than 5:00 p.m. EDT on September 9, 2016.

ADDRESSES: (1) The draft report and draft recommendations are available 
on the web at http://www.hhs.gov/nvpo/nvac/index.html.
    (2) Electronic responses are preferred and may be addressed to: 
[email protected].
    (3) Written responses should be addressed to: National Vaccine 
Program Office, U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Room 733G.5, Washington, DC 20201, Attn: HHS 
Maternal Immunizations c/o Dr. Karin Bok.

FOR FURTHER INFORMATION CONTACT: 
    Karin Bok, MS, Ph.D., National Vaccine Program Office, Office of 
the Assistant Secretary for Health, Department of Health and Human 
Services; telephone (202) 690-1191; fax (202) 260-1165; email 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Maternal immunizations have been an effective strategy to protect 
both the mother and the young infant against vaccine-preventable 
diseases. However, significant barriers remain that prevent the 
development and licensing of additional vaccines for use in maternal 
immunization strategies. Some of those barriers include ethics and 
policy considerations about including pregnant women in clinical 
research, the need for continued support of pre-clinical and clinical 
research on immunity, the impact and safety of immunizations during 
pregnancy, and educating obstetrical providers about the benefits of 
immunizations during pregnancy and the importance of including pregnant 
women in clinical research in order to provide the highest quality of 
healthcare.
    HHS recognized the need to address these barriers and subsequently 
charged the NVAC with making recommendations that would address the 
problem. The NVAC separated the task into two sections as it was first 
necessary to address and understand the demand for maternal 
immunizations in order to then address the challenges in developing 
maternal immunizations. The MIWG Phase I focused on understanding the 
demand for maternal immunization programs by identifying existing 
patient and provider barriers to maternal immunization, which addressed 
the first part of the charge. Then, the MIWG Phase II focused on the 
second part of the charge, which was to identify barriers to and 
opportunities for developing vaccines for pregnant women and to make 
recommendations to overcome these barriers. Through a series of 
teleconferences, electronic communications, and public discussions 
during the NVAC meetings, the working group identified a number of 
draft recommendations. These recommendations were categorized into four 
priority areas that represent opportunities for developing and 
licensing new vaccines for pregnant women. These four categories 
include:

Focus Area 1: Ethical Issues
Focus Area 2: Policy Issues
Focus Area 3: Pre-Clinical and Clinical Research Issues
Focus Area 4: Provider Education and Support Issues

Within each focus area the NVAC report details key recommendations to 
overcoming challenges in these areas. The NVAC report also provides the 
rationale for these recommendations and input on how the ASH might 
support HHS activities in these areas.

II. Request for Comment

    NVPO, on behalf of the NVAC MIWG Phase II, 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 
efforts and/or barriers to maternal immunizations not presented in the 
report where HHS efforts could advance maternal immunization efforts. 
Please limit your comments to six (6) pages.

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III. Potential Responders

    HHS invites input from a broad range of stakeholders including 
individuals and organizations that have interests in maternal 
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;
--obstetrical care provider groups including all physician and non-
physician providers that administer healthcare services to pregnant 
women, 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: August 16, 2016.
Bruce Gellin,
Executive Secretary, National Vaccine Advisory Committee, Deputy 
Assistant Secretary for Health, Director, National Vaccine Program 
Office.
[FR Doc. 2016-20525 Filed 8-25-16; 8:45 am]
 BILLING CODE 4150-44-P