80 FR 18424 - Solicitation of Written Comments on the National Vaccine Advisory Committee's Draft Report and Draft Recommendations for Consideration for Addressing the State of Vaccine Confidence in the United States

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 65 (April 6, 2015)

Page Range		18424-18426
FR Document		2015-07778

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 her capacity as the Director of National Vaccine Program on matters related to vaccine program responsibilities. Recognizing that immunizations are given across the lifespan and there are likely to be important differences in vaccine acceptance at different stages of life, in February of 2013 the National Vaccine Advisory Committee accepted an initial charge from the Assistant Secretary for Health (ASH) to report on how confidence in vaccines impacts the optimal use of recommended childhood vaccines in the United States, including reaching Healthy People 2020 immunization coverage targets. Focus of such a report may include understanding the determinants of vaccination acceptance among parents, what HHS should be doing to improve parental confidence in vaccine recommendations and how to best measure confidence in vaccine and vaccination to inform and evaluate interventions in the future. Through a series of teleconferences, electronic communications, presentations and public discussions during the NVAC meetings, a working group identified a number of draft recommendations to further understand and address issues of vaccine confidence in the United States. 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 June 2015 at the quarterly NVAC meeting.

Federal Register, Volume 80 Issue 65 (Monday, April 6, 2015)

[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18424-18426]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the National Vaccine Advisory 
Committee's Draft Report and Draft Recommendations for Consideration 
for Addressing the State of Vaccine Confidence in the United States

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, National Vaccine Program Office, 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 her capacity as the Director of National Vaccine Program on matters 
related to vaccine program responsibilities.
    Recognizing that immunizations are given across the lifespan and 
there are likely to be important differences in vaccine acceptance at 
different stages of life, in February of 2013 the National Vaccine 
Advisory Committee accepted an initial charge from the Assistant 
Secretary for Health (ASH) to report on how confidence in vaccines 
impacts the optimal use of recommended childhood vaccines in the United 
States, including reaching Healthy People 2020 immunization coverage 
targets. Focus of such a report may include understanding the 
determinants of vaccination acceptance among parents, what HHS should 
be doing to improve parental confidence in vaccine recommendations and 
how to best measure confidence in vaccine and vaccination to inform and 
evaluate interventions in the future.
    Through a series of teleconferences, electronic communications, 
presentations and public discussions during the NVAC meetings, a 
working group identified a number of draft recommendations to further 
understand and address issues of vaccine confidence in the United 
States.
    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 June 2015 at the quarterly NVAC 
meeting.

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-vaccine-confidence-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 733G, Washington, DC 20201. Attn: Vaccine 
Confidence Working Group.

FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 
Office of the Assistant Secretary for Health,

[[Page 18425]]

Department of Health and Human Services; telephone (202) 690-5566; fax 
(202) 690-4631; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Vaccination confidence is one of a number of factors that affect 
individual and population-level willingness to accept a vaccine. 
Vaccine confidence means having confidence in the safety and efficacy 
of a vaccine, having confidence in the competence of the health 
professionals who administer the vaccine, and having trust in the 
motivations of the policy-makers who decide which vaccines are needed 
and when. Vaccine confidence has been shown to influence vaccine 
decision making, but to what extent remains unclear. This is partly due 
to a lack of consensus on how best to quantify the confidence of an 
individual and a population. Gaining this understanding along with 
identifying factors which drive public confidence is critical for 
assessing the magnitude of the problem in the U.S., as well as 
designing and evaluating potential intervention strategies.
    Through their analysis and discussion, the NVAC proposes the 
following recommendations:

Focus Area 1: Measuring and Tracking Vaccine Confidence

    1.1 NVAC recommends development of an ``index,'' composed of a 
number of individual and social dimensions, to measure vaccine 
confidence. This index should be capable of (1) a rapid, reliable and 
valid surveillance of national vaccine confidence; (2) detection and 
identification of variations in vaccine confidence at the community 
level; and (3) diagnosis of the key dimensions that affect vaccine 
confidence.
    1.2 NVAC recommends continuing the use of existing measures for 
vaccine confidence, including systems that measure vaccine coverage as 
well as vaccine-related confidence, attitudes and beliefs while the 
science of understanding and tracking vaccine confidence is being 
advanced.
    1.3 NVAC recommends the development of measures and methods to 
analyze the mass media environment and social media conversations to 
identify topics of concern to parents, healthcare providers, and 
members of the public.
    1.4 NVAC recommends that existing approaches and systems for 
monitoring vaccination coverages and vaccine-related cognitions, 
attitudes, and behaviors be strengthened and enhanced. These include: 
(1) Immunization Information Systems (IIS) and Electronic Health 
Records (EHRs) to collect and capture delays and refusals; (2) Reliable 
and valid measures (or surveys) of cognitive factors, such as adults 
and parents' confidence, attitudes, and beliefs regarding vaccines and 
recommended vaccinations; (3) Surveys of provider attitudes and beliefs 
towards vaccination; and (4) Integration of data from all existing 
systems to track trends of vaccination confidence over time and to 
detect variations across time and geography.

Focus Area 2: Communication and Community Strategies

    2.1 NVAC recommends healthcare providers, immunization programs, 
and those involved in promoting recommended vaccinations actively 
reinforce that vaccination according to the Advisory Committee on 
Immunization Practices (ACIP) recommended schedule is the social norm 
and not the exception. Misperceptions that vaccination in line with the 
ACIP recommended schedule is not the norm should be appropriately 
addressed.
    2.2 NVAC recommends consistent communications assessment and 
feedback pertaining to vaccine confidence. These include:
    2.2.1 Creation of a Communication Assessment Infrastructure to 
assess vaccine sentiment and provide timely, accurate and actionable 
information related to vaccination confidence and acceptance to 
relevant stakeholders. This system should have the capability to 
regularly assess vaccine-related messaging environment (e.g., to 
identify new or emerging concerns and questions) to assess 
understanding and effectiveness of population education and information 
materials and resources.
    2.2.2 Identification, evaluation and validation of communication 
resources and approaches in terms of their effects on enhancing vaccine 
and vaccination confidence so that effective (``evidence-based/
evidence-informed'') interventions and best practices can be shared and 
more widely used.
    2.2.3 Creation of a repository of evidenced-based best practices 
for informing, educating, and communicating with parents and others in 
ways that foster or increase vaccine or vaccination confidence. This 
repository would be maintained and expanded as future evidence is 
compiled regarding messages, materials, and interventions that 
positively affect vaccine or vaccination confidence.
    2.3 NVAC recommends the development of systems to support parent 
and community efforts that seek to promote vaccine confidence and 
vaccination.
    2.4 NVAC recommends support for a community of practice or network 
of stakeholders who are actively taking steps to foster or grow vaccine 
confidence and vaccination; such a network can foster partnerships and 
encourage sharing of resources and best practices.

Focus Area 3: Healthcare Provider Strategies

    3.1 NVAC recommends the development and deployment of evidence-
based materials and toolkits for providers to address parent questions 
and concerns. These materials and toolkits should continue to be 
revised to incorporate the latest science and research.
    3.1.1 A repository of evidence-based effective practices for 
providers should be an output of this effort.
    3.2 NVAC recommends curriculum and communication training that 
focuses on vaccine confidence (e.g., strategies and approaches for 
establishing or building confidence) be developed and made available 
for healthcare providers, including doctors, nurses, alternative 
providers, and ancillary care providers.
    3.2.1 This training should encompass ``providers-in-training,'' 
such as students, residents, and interns as well as currently 
practicing physicians, nurses, and other healthcare providers through 
Continuing Medical Education (CMEs).
    3.2.2 Clear and accessible information on vaccinations, the 
schedule and any changes to the immunization schedule should be 
developed specifically for providers and made available to them through 
resources they utilize most.
    3.3 NVAC recommends the development of: (i) Provisional billing 
codes for vaccine counseling when vaccination is ultimately not given; 
and (ii) Pay for performance initiatives and incentives as measured by: 
(a) Establishment of an immunizing standard within a practice; and (b) 
Continued improvement in immunization coverage rates within a 
provider's practice.

Focus Area 4: Policy Strategies

    4.1 NVAC recommends states and territories with existing personal 
belief exemption policies should assess their policies to assure that 
exemptions are only available after appropriate parent education and 
acknowledgement of the associated risks of not vaccinating, to

[[Page 18426]]

their child and community. Policies that do not do this should be 
strengthened.
    4.1.1 Increased efforts should be made to educate the public and 
state legislatures on the safety and value of vaccines, the importance 
of recommended vaccinations and the ACIP schedule, and the risks posed 
by low or under-vaccination in communities and schools.
    4.2 NVAC recommends information on vaccination rates, vaccination 
exemptions, and other preventative health measures (e.g., whether a 
school has a school nurse, etc.) for an educational institution be made 
available to parents.
    4.2.1 Encourage educational institutions and childcare facilities 
to report vaccination rates publicly (e.g., via a school health grade 
or report).
    4.3 NVAC recommends ``on-time vaccination'' should be included as a 
Quality Measure for all health plans, public and private, as a first 
line indicator of vaccine confidence. NVAC acknowledges that other 
issues, such as access, can also effect on time vaccination.

Final Recommendation

    5.1 The NVAC recommends that the National Vaccine Program Office 
(NVPO) should work with federal and non-federal partners to develop an 
implementation plan to address vaccine confidence, including metrics, 
and report back to NVAC on progress, annually.

II. Request for Comment

    NVPO, on behalf of the NVAC Vaccine Confidence Working Group, 
requests input on the draft report and draft recommendations. Please 
limit your comments to three (3) pages.

III. Potential Responders

    HHS invites input from a broad range of stakeholders including 
individuals and organizations that have interests in 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;
--pediatric provider groups including all physician and non-physician 
providers that administer healthcare services to children, including 
pharmacists; and
--representatives from the private sector, including those from health 
insurance organizations.

    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 three to five (3-5) pages. Please do not send proprietary, 
commercial, financial, business, confidential, trade secret, or 
personal information.

    Dated: March 31, 2015.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, Executive Secretary, National Vaccine Advisory 
Committee.
[FR Doc. 2015-07778 Filed 4-3-15; 8:45 am]
BILLING CODE 4150-44-P

18424 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices

The Transparency Act requires the VIII. Other Information National Vaccine Program on matters
OMB to establish a single searchable The Public Health Service strongly related to vaccine program
database, accessible to the public, with encourages all cooperative agreement responsibilities.
information on financial assistance and contract recipients to provide a Recognizing that immunizations are
awards made by Federal agencies. The smoke-free workplace and promote the given across the lifespan and there are
Transparency Act also includes a non-use of all tobacco products. In likely to be important differences in
requirement for recipients of Federal addition, Public Law 103–227, the Pro- vaccine acceptance at different stages of
grants to report information about first- Children Act of 1994, prohibits smoking life, in February of 2013 the National
tier subawards and executive in certain facilities (or in some cases, Vaccine Advisory Committee accepted
compensation under Federal assistance any portion of the facility) in which an initial charge from the Assistant
awards. regular or routine education, library, Secretary for Health (ASH) to report on
IHS has implemented a Term of day care, health care, or early childhood how confidence in vaccines impacts the
Award into all IHS Standard Terms and development services are provided to optimal use of recommended childhood
Conditions, NoAs and funding children. This is consistent with the vaccines in the United States, including
announcements regarding the FSRS HHS mission to protect and advance the reaching Healthy People 2020
reporting requirement. This IHS Term of physical and mental health of the immunization coverage targets. Focus of
Award is applicable to all IHS grant and American people. such a report may include
cooperative agreements issued on or understanding the determinants of
after October 1, 2010, with a $25,000 Dated: March 29, 2015. vaccination acceptance among parents,
subaward obligation dollar threshold Robert G. McSwain, what HHS should be doing to improve
met for any specific reporting period. Acting Director, Indian Health Service. parental confidence in vaccine
Additionally, all new (discretionary) [FR Doc. 2015–07780 Filed 4–3–15; 8:45 am] recommendations and how to best
IHS awards (where the project period is BILLING CODE 4165–16–P measure confidence in vaccine and
made up of more than one budget vaccination to inform and evaluate
period) and where: 1) The project period interventions in the future.
start date was October 1, 2010 or after DEPARTMENT OF HEALTH AND Through a series of teleconferences,
and 2) the primary awardee will have a HUMAN SERVICES electronic communications,
$25,000 subaward obligation dollar presentations and public discussions
threshold during any specific reporting Solicitation of Written Comments on during the NVAC meetings, a working
period will be required to address the the National Vaccine Advisory group identified a number of draft
FSRS reporting. For the full IHS award Committee’s Draft Report and Draft recommendations to further understand
term implementing this requirement Recommendations for Consideration and address issues of vaccine
and additional award applicability for Addressing the State of Vaccine confidence in the United States.
information, visit the DGM Grants Confidence in the United States On behalf of NVAC, NVPO is
Policy Web site at: https://www.ihs.gov/ AGENCY: Office of the Secretary, Office soliciting public comment on the draft
dgm/index.cfm?module=dsp_dgm_ of the Assistant Secretary for Health, report and draft recommendations from
policy_topics. National Vaccine Program Office, a variety of stakeholders, including the
Telecommunication for the hearing Department of Health and Human general public, for consideration by the
impaired is available at: TTY (301) 443– Services NVAC as they develop their final
6394. recommendations to the ASH. It is
ACTION: Notice. anticipated that the draft report and
VII. Agency Contacts draft recommendations, as revised with
SUMMARY: The National Vaccine
1. Questions on the programmatic Advisory Committee (NVAC) was consideration given to public comment
issues may be directed to: established in 1987 to comply with Title and stakeholder input, will be presented
Mr. Chris Buchanan, Director, ODSCT, XXI of the Public Health Service Act to the NVAC for adoption in June 2015
801 Thompson Avenue, Suite 220, (Pub. L. 99–660) (§ 2105) (42 U.S. Code at the quarterly NVAC meeting.
Rockville, Maryland 20852. 300aa–5 (PDF–78 KB)). Its purpose is to DATES: Comments for consideration by
Telephone: (301) 443–1104. E-Mail: advise and make recommendations to the NVAC should be received no later
Chris.Buchanan@ihs.gov. the Director of the National Vaccine than 5:00 p.m. EDT on May 6, 2015.
2. Questions on grants management Program on matters related to program ADDRESSES:
and fiscal matters may be directed to: responsibilities. The Assistant Secretary (1) The draft report and draft
for Health (ASH) has been designated by recommendations are available on the
Mr. John Hoffman, DGM, Grants Web at http://www.hhs.gov/nvpo/nvac/
the Secretary of Health and Human
Management Specialist, 801 subgroups/nvac-vaccine-confidence-
Services (HHS) as the Director of the
Thompson Avenue, TMP Suite 360, wg.html.
National Vaccine Program. The National
Rockville, Maryland 20852. (2) Electronic responses are preferred
Vaccine Program Office (NVPO) is
Telephone: (301) 443–2116 Fax: (301) and may be addressed to: vcwg@
located within the Office of the
443–9602. E-Mail: John.Hoffman@ hhs.gov.
Assistant Secretary for Health (OASH),
ihs.gov. (3) Written responses should be
Office of the Secretary, U.S. Department
3. Questions on systems matters may of Health and Human Services (HHS). addressed to: National Vaccine Program
be directed to: NVPO provides leadership and fosters Office, U.S. Department of Health and
tkelley on DSK4VPTVN1PROD with NOTICES

Paul Gettys, Grant Systems Coordinator, collaboration among the various federal Human Services, 200 Independence
DGM, 801 Thompson Avenue, TMP agencies involved in vaccine and Avenue SW., Room 733G, Washington,
Suite 360, Rockville, MD 20852. immunization activities. The NVPO also DC 20201. Attn: Vaccine Confidence
Phone: 301–443–2114; or the DGM supports the National Vaccine Advisory Working Group.
main line 301–443–5204. Fax: 301– Committee (NVAC). The NVAC advises FOR FURTHER INFORMATION CONTACT:
443–9602. E-Mail: Paul.Gettys@ and makes recommendations to the National Vaccine Program Office, Office
ihs.gov. ASH in her capacity as the Director of of the Assistant Secretary for Health,

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18426 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices

their child and community. Policies that —representatives from the private Proposed Project: Notification of Intent
do not do this should be strengthened. sector, including those from health To Use Schedule III, IV, or V Opioid
4.1.1 Increased efforts should be insurance organizations. Drugs for the Maintenance and
made to educate the public and state Detoxification Treatment of Opiate
legislatures on the safety and value of When responding, please self-identify Addiction Under 21 U.S.C. 823(g)(2)
vaccines, the importance of with any of the above or other categories (OMB No. 0930–0234)—Extension
recommended vaccinations and the (include all that apply) and your name.
Anonymous submissions will not be The Drug Addiction Treatment Act of
ACIP schedule, and the risks posed by 2000 (‘‘DATA,’’ Pub. L. 106–310)
low or under-vaccination in considered. Written submissions should
not exceed three to five (3–5) pages. amended the Controlled Substances Act
communities and schools. (21 U.S.C. 823(g)(2)) to permit
4.2 NVAC recommends information Please do not send proprietary,
practitioners (physicians) to seek and
on vaccination rates, vaccination commercial, financial, business,
obtain waivers to prescribe certain
exemptions, and other preventative confidential, trade secret, or personal
approved narcotic treatment drugs for
health measures (e.g., whether a school information. the treatment of opiate addiction. The
has a school nurse, etc.) for an
Dated: March 31, 2015. legislation sets eligibility requirements
educational institution be made
Bruce Gellin, and certification requirements as well as
available to parents.
4.2.1 Encourage educational Deputy Assistant Secretary for Health, an interagency notification review
institutions and childcare facilities to Director, National Vaccine Program Office, process for physicians who seek
report vaccination rates publicly (e.g., Executive Secretary, National Vaccine waivers. The legislation was amended
via a school health grade or report). Advisory Committee. in 2005 to eliminate the patient limit for
4.3 NVAC recommends ‘‘on-time [FR Doc. 2015–07778 Filed 4–3–15; 8:45 am] physicians in group practices, and in
vaccination’’ should be included as a BILLING CODE 4150–44–P
2006, to permit certain physicians to
Quality Measure for all health plans, treat up to 100 patients.
public and private, as a first line To implement these provisions,
indicator of vaccine confidence. NVAC DEPARTMENT OF HEALTH AND SAMHSA developed a notification form
acknowledges that other issues, such as HUMAN SERVICES (SMA–167) that facilitates the
access, can also effect on time submission and review of notifications.
vaccination. Substance Abuse and Mental Health The form provides the information
Services Administration necessary to determine whether
Final Recommendation practitioners (i.e., independent
5.1 The NVAC recommends that the Agency Information Collection physicians) meet the qualifications for
National Vaccine Program Office Activities: Proposed Collection; waivers set forth under the new law.
(NVPO) should work with federal and Comment Request Use of this form will enable physicians
non-federal partners to develop an to know they have provided all
implementation plan to address vaccine In compliance with section information needed to determine
confidence, including metrics, and 3506(c)(2)(A) of the Paperwork whether practitioners are eligible for a
report back to NVAC on progress, Reduction Act of 1995 concerning waiver.
annually. opportunity for public comment on However, there is no prohibition on
proposed collections of information, the use of other means to provide requisite
II. Request for Comment information. The Secretary will convey
Substance Abuse and Mental Health
NVPO, on behalf of the NVAC notification information and
Services Administration (SAMHSA)
Vaccine Confidence Working Group, determinations to the Drug Enforcement
will publish periodic summaries of
requests input on the draft report and Administration (DEA), which will
proposed projects. To request more assign an identification number to
draft recommendations. Please limit
information on the proposed projects or qualifying practitioners; this number
your comments to three (3) pages.
to obtain a copy of the information will be included in the practitioner’s
III. Potential Responders collection plans, call the SAMHSA registration under 21 U.S.C. 823(f).
HHS invites input from a broad range Reports Clearance Officer on (240) 276– Practitioners may use the form for
of stakeholders including individuals 1243. three types of notification: (a) New, (b)
and organizations that have interests in Comments are invited on: (a) Whether immediate, and (c) to notify of their
immunization efforts and the role of the proposed collections of information intent to treat up to 100 patients. Under
HHS in advancing those efforts. are necessary for the proper ‘‘new’’ notifications, practitioners may
Examples of potential responders performance of the functions of the make their initial waiver requests to
include, but are not limited to, the agency, including whether the SAMHSA. ‘‘Immediate’’ notifications
following: information shall have practical utility; inform SAMHSA and the Attorney
—General public; (b) the accuracy of the agency’s estimate General of a practitioner’s intent to
—advocacy groups, non-profit of the burden of the proposed collection prescribe immediately to facilitate the
organizations, and public interest treatment of an individual (one) patient
of information; (c) ways to enhance the
organizations; under 21 U.S.C. 823(g)(2)(E)(ii). Finally,
quality, utility, and clarity of the
—academics, professional societies, and the form may be used by physicians
information to be collected; and (d) with waivers to certify their need and
healthcare organizations;
ways to minimize the burden of the
tkelley on DSK4VPTVN1PROD with NOTICES

—public health officials and intent to treat up to 100 patients.
immunization program managers; collection of information on The form collects data on the
—pediatric provider groups including respondents, including through the use following items: Practitioner name; state
all physician and non-physician of automated collection techniques or medical license number and DEA
providers that administer healthcare other forms of information technology. registration number; address of primary
services to children, including location, telephone and fax numbers;
pharmacists; and email address; name and address of

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Document Created: 2015-12-18 11:18:35
Document Modified: 2015-12-18 11:18:35

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 5:00 p.m. EDT on May 6, 2015.
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]
FR Citation		80 FR 18424