[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]
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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.
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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 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]
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