[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Pages 16797-16798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06594]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the Maternal Immunizations 
Working Group's Draft Report and Draft Recommendations for Reducing 
Patient and Provider Barriers to 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.

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

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 300aa-5 (PDF-78 KB) ). 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 his capacity as the Director of National 
Vaccine Program on matters related to vaccine program responsibilities.
    In June 2012, the NVAC accepted a charge from the ASH to review the 
current state of maternal immunization and existing best practices and 
identify programmatic barriers to the implementation of current 
recommendations related to maternal immunization. The NVAC formed the 
Maternal Immunizations Working Group in August 2012 to address this 
charge.
    Through a series of teleconferences, electronic communications, and 
public discussions during NVAC meetings, the working group developed a 
number of draft recommendations for consideration by the NVAC. The NVAC 
draft report details the background and rationale for each of these 
recommendations and provides input on how the ASH might support HHS 
activities in these areas. 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.
    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 June 2014 at the quarterly NVAC meeting.

DATES: Comments for consideration by the NVAC should be received no 
later than 5:00 p.m. EDT on April 25, 2014.

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, Washington, DC 20201. Attn: HHS 
Maternal Immunizations c/o Dr. Jennifer Gordon

FOR FURTHER INFORMATION CONTACT: Jennifer Gordon, Ph.D., National 
Vaccine Program Office, Office of the Assistant Secretary for Health, 
Department of Health and Human Services; telephone (202) 260-6619; fax 
(202) 260-1165; email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Pregnant women and their infants are at increased risk for serious 
complications due to vaccine-preventable diseases. For example, during 
the 2009 H1N1 influenza pandemic, pregnant women accounted for five 
percent of all reported H1N1-related deaths and were 7.2 times more

[[Page 16798]]

likely to be hospitalized than non-pregnant women. Infants too young to 
be vaccinated are also vulnerable to severe outcomes and death due to 
influenza and pertussis disease. Maternal immunization is an important 
strategy to protect both pregnant women and their young infants from 
vaccine-preventable disease, and both the Advisory Committee for 
Immunization Practices and the American College of Obstetricians and 
Gynecologists recommend that all pregnant women receive immunizations 
against influenza and pertussis disease during every pregnancy. 
However, despite evidence to support clear health benefits of maternal 
immunization for pregnant women and infant, immunization coverage in 
pregnant women remains low. In addition, many pregnant women reported 
that their provider did not recommend that they receive vaccines, 
indicating ongoing missed opportunities during healthcare interactions. 
Therefore, it is critical to understand the barriers that both prevent 
pregnant women from receiving recommended vaccinations and those that 
prevent obstetrical care providers from recommending and administering 
vaccines within their practices. Doing so will help to advance maternal 
immunization efforts and increase coverage to maximize the number of 
pregnant women and young infants that can benefit from these 
strategies.
    Through their analysis and discussion, the NVAC identified five 
major areas of opportunity:
    1. Enhancing communication to address the safety and effectiveness 
of all currently recommended immunizations during pregnancy;
    2. Maximizing obstetric provider recommendation and administration 
of recommended maternal immunizations;
    3. Focusing efforts to improve financing for immunization services 
during pregnancy and postpartum;
    4. Supporting efforts to increase the use of electronic health 
records (EHRs) and Immunization Information Systems (IISs) among 
obstetrical care providers; and
    5. Recognizing and addressing current vaccine liability law 
barriers to optimize investigations and uptake of recommended and 
future vaccines during pregnancy.
    Within each area the NVAC report details key recommendations to 
overcoming challenges in these areas.

II. Request for Comment

    NVPO, on behalf of the NVAC Maternal Immunizations 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 efforts or barriers to 
maternal immunizations not represented in the report where HHS efforts 
could advance maternal immunization efforts. 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 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: March 13, 2014.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, Executive Secretary, National Vaccine Advisory 
Committee.
[FR Doc. 2014-06594 Filed 3-25-14; 8:45 am]
BILLING CODE 4150-44-P