[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18405-18406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the Human Papillomavirus 
Working Group's Draft Report and Draft Recommendations for Improving 
Vaccination Rates in Adolescents 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

[[Page 18406]]

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 National Vaccine Program on matters related to vaccine 
program responsibilities.
    In February 2013, the NVAC created a working group to review the 
current state of HPV immunization, to understand the root cause(s) for 
the observed low vaccine uptake, both in initiation and in series 
completion, and to identify existing best practices to increase the use 
of the HPV vaccine in young adolescents.
    Through a series of teleconferences, electronic communications, and 
public discussions during the NVAC meetings, a working group identified 
a number of draft recommendations categorized into five priority areas 
of opportunity for improving vaccination coverage among adolescents. 
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. Comments will be considered by the NVAC 
as it develops its 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 discussion and adoption in NVAC meeting in 
June 2015.

DATES: Comments for consideration by the NVAC should be received no 
later than 5:00 p.m. EDT on May 6, 2015.

ADDRESSES: 
    (1) The draft report and draft recommendations are available on the 
web at http://www.hhs.gov/nvpo/nvac/subgroups/nvac-hpv-wg.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 715H, Washington, DC 20201. Attn: HHS HPV 
Immunizations.

FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services; telephone (202) 690-5566; fax (202) 690-4631; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    There are an average of 25,900 newly diagnosed cases per year of 
human papillomavirus (HPV)-associated cancer in the United States. An 
estimated 14 million people are newly infected with HPV each year and 
nearly half of these infections occur in people between the ages of 14-
25 years. While most infections resolve over time, persistent infection 
with oncogenic HPV types is associated with a variety of cancers. 
Virtually all cervical cancers are due to HPV along with 90 percent of 
anal, 69 percent of vaginal, 60 percent of oropharyngeal, 51 percent of 
vulvar, and 40 percent of penile cancers. Further, 87 percent of anal, 
76 percent of cervical, 60 percent of oropharyngeal, 55 percent of 
vaginal, 44 percent of vulva and 29 percent of penile cancers are 
caused by oncogenic HPV types 16 or 18. Of the 35,000 HPV cancers 
reported in 2009 in the U.S., 39 percent occurred in males.
    Through their analysis and discussion, the NVAC identified five 
major areas of opportunity:
    (1) Endorsing the President's Cancer Panel (PCP) report, 
Accelerating HPV Vaccine Uptake: Urgency for Action to Prevent Cancer, 
and adopt the recommendations outlined therein.
    (2) Monitoring ``the status of uptake and implementation of the 
recommendations'' through an annual progress report from HPV 
vaccination stakeholders identified in the PCP report.
    (3) Working with relevant agencies and stakeholders to develop 
evidence-based, effective, coordinated communication strategies to 
increase the strength and consistency of clinician recommendations for 
HPV vaccination to adolescents (both males and females) in the 
recommended age groups and to improve acceptance among parents/
guardians, adolescents and young adults.
    (4) Working with the relevant agencies and stakeholders to 
strengthen the immunization system in order to maximize access to and 
support of adolescent vaccinations, including HPV vaccines.
    (5) Encouraging the review or development of available data that 
could lead to a simplified HPV vaccination schedule. In addition to a 
review that could impact existing vaccines, manufacturers of HPV 
vaccines in development should also consider opportunities to support 
the simplest HPV immunization schedule while maintaining vaccine 
effectiveness, safety, and long-term protection.

II. Request for Comment

    NVPO, on behalf of the NVAC HPV 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 HPV immunization not represented in the 
report where HHS efforts could advance adolescent 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 HPV 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;
--adolescent provider groups including all physician and non-physician 
providers that administer healthcare services to adolescents, 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 20, 2015.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, Executive Secretary, National Vaccine Advisory 
Committee.
[FR Doc. 2015-07777 Filed 4-3-15; 8:45 am]
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