81 FR 58947 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 166 (August 26, 2016)

Page Range		58947-58948
FR Document		2016-20525

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.

Federal Register, Volume 81 Issue 166 (Friday, August 26, 2016)

[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58947-58948]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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.

[[Page 58948]]

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

Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices 58947

DEPARTMENT OF HEALTH AND the working group identified a number clinical research on immunity, the
HUMAN SERVICES of draft recommendations for impact and safety of immunizations
consideration by the NVAC. These during pregnancy, and educating
Solicitation of Written Comments on recommendations represent obstetrical providers about the benefits
the Maternal Immunizations Working opportunities for developing and of immunizations during pregnancy and
Group Phase II’s Draft Report and Draft licensing new vaccines for pregnant the importance of including pregnant
Recommendations for Overcoming women. The draft report and draft women in clinical research in order to
Barriers and Identifying Opportunities recommendations from the working provide the highest quality of
for Developing Maternal Immunizations group will inform NVAC deliberations healthcare.
for Consideration by the National as the NVAC finalizes their HHS recognized the need to address
Vaccine Advisory Committee recommendations for transmittal to the these barriers and subsequently charged
ASH. the NVAC with making
AGENCY: National Vaccine Program
On behalf of NVAC, NVPO is recommendations that would address
Office, Office of the Assistant Secretary
soliciting public comment on the draft the problem. The NVAC separated the
for Health, Office of the Secretary,
report and draft recommendations from task into two sections as it was first
Department of Health and Human
a variety of stakeholders, including the necessary to address and understand the
Services.
general public, for consideration by the demand for maternal immunizations in
ACTION: Notice.
NVAC as they develop their final order to then address the challenges in
SUMMARY: The National Vaccine recommendations to the ASH. It is developing maternal immunizations.
Advisory Committee (NVAC) was anticipated that the draft report and The MIWG Phase I focused on
established in 1987 to comply with Title draft recommendations, as revised with understanding the demand for maternal
XXI of the Public Health Service Act consideration given to public comment immunization programs by identifying
(Pub. L. 99–660) (§ 2105) (42 U.S. Code and stakeholder input, will be presented existing patient and provider barriers to
Section 300aa–5). Its purpose is to to the NVAC for adoption in September maternal immunization, which
advise and make recommendations to 2016 at the quarterly NVAC meeting. addressed the first part of the charge.
the Director of the National Vaccine DATES: Comments for consideration by Then, the MIWG Phase II focused on the
Program on matters related to the the NVAC should be received no later second part of the charge, which was to
program’s responsibilities. The than 5:00 p.m. EDT on September 9, identify barriers to and opportunities for
Assistant Secretary for Health (ASH) has 2016. developing vaccines for pregnant
been designated by the Secretary of ADDRESSES: (1) The draft report and women and to make recommendations
Health and Human Services (HHS) as draft recommendations are available on to overcome these barriers. Through a
the Director of the National Vaccine the web at http://www.hhs.gov/nvpo/ series of teleconferences, electronic
Program. The National Vaccine Program nvac/index.html. communications, and public
Office (NVPO) is located within the (2) Electronic responses are preferred discussions during the NVAC meetings,
Office of the Assistant Secretary for and may be addressed to: nvpo@ the working group identified a number
Health (OASH), Office of the Secretary, hhs.gov. of draft recommendations. These
U.S. Department of Health and Human (3) Written responses should be recommendations were categorized into
Services (HHS). The NVPO provides addressed to: National Vaccine Program four priority areas that represent
leadership and fosters collaboration Office, U.S. Department of Health and opportunities for developing and
among the various federal agencies Human Services, 200 Independence licensing new vaccines for pregnant
involved in vaccine and immunization Avenue SW., Room 733G.5, women. These four categories include:
activities. The NVPO also provides Washington, DC 20201, Attn: HHS Focus Area 1: Ethical Issues
management and support services for Maternal Immunizations c/o Dr. Karin Focus Area 2: Policy Issues
the National Vaccine Advisory Bok. Focus Area 3: Pre-Clinical and Clinical
Committee (NVAC). The NVAC advises Research Issues
and makes recommendations to the FOR FURTHER INFORMATION CONTACT:
ASH in his/her capacity as the Director Karin Bok, MS, Ph.D., National Focus Area 4: Provider Education and
of the National Vaccine Program on Vaccine Program Office, Office of the Support Issues
matters related to the program’s Assistant Secretary for Health, Within each focus area the NVAC report
responsibilities. Department of Health and Human details key recommendations to
Recognizing the importance and Services; telephone (202) 690–1191; fax overcoming challenges in these areas.
impact of maternal immunizations on (202) 260–1165; email Karin.Bok@ The NVAC report also provides the
public health, the ASH charged the hhs.gov. rationale for these recommendations
NVAC in June 2012 with reviewing the SUPPLEMENTARY INFORMATION: and input on how the ASH might
state of maternal immunizations and support HHS activities in these areas.
existing best practices to identify I. Background
II. Request for Comment
programmatic gaps and/or barriers to Maternal immunizations have been an
the implementation of current effective strategy to protect both the NVPO, on behalf of the NVAC MIWG
recommendations regarding maternal mother and the young infant against Phase II, requests input on the draft
immunization. The NVAC established vaccine-preventable diseases. However, report and draft recommendations. In
the Maternal Immunization Working significant barriers remain that prevent addition to general comments on the
mstockstill on DSK3G9T082PROD with NOTICES

Group (MIWG) in August 2012 to the development and licensing of draft report and draft recommendations,
conduct these assessments and provide additional vaccines for use in maternal NVPO is seeking input on efforts and/
recommendations for overcoming any immunization strategies. Some of those or barriers to maternal immunizations
identified barriers. barriers include ethics and policy not presented in the report where HHS
Through a series of teleconferences, considerations about including pregnant efforts could advance maternal
electronic communications, and public women in clinical research, the need for immunization efforts. Please limit your
discussions during the NVAC meetings, continued support of pre-clinical and comments to six (6) pages.

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58948 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices

III. Potential Responders Name of Committee: National Institute of Date: September 26, 2016.
Diabetes and Digestive and Kidney Diseases Time: 12:00 p.m. to 2:00 p.m.
HHS invites input from a broad range Special Emphasis Panel; R18 and R34. Agenda: To review and evaluate grant
of stakeholders including individuals Date: September 15, 2016. applications.
and organizations that have interests in Time: 9:00 a.m. to 5:00 p.m. Place: National Institutes of Health, Two
maternal immunization efforts and the Agenda: To review and evaluate grant Democracy Plaza, 6707 Democracy
role of HHS in advancing those efforts. applications. Boulevard, Bethesda, MD 20892 (Telephone
Examples of potential responders Place: Bethesda Marriott Suites, 6711 Conference Call).
include, but are not limited to, the Democracy Boulevard, Bethesda, MD 20817. Contact Person: Najma Begum, Ph.D.,
Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch,
following:
Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
—General public; DEA, NIDDK, National Institutes of Health, Room 7349, 6707 Democracy Boulevard,
—advocacy groups, non-profit Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894,
organizations, and public interest Bethesda, MD 20892–2542, (301) 594–8898, begumn@niddk.nih.gov.
organizations; barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of
—academics, professional societies, and Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases
healthcare organizations; Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR–15–067:
—public health officials and Special Emphasis Panel; NIDDK Ancillary NIDDK Multi-Center Clinical Study
immunization program managers; Studies (R01). Cooperative Agreement (U01): CKD and
—obstetrical care provider groups Date: September 15, 2016. Mineral Bone Disorders in Children.
including all physician and non- Time: 11:00 a.m. to 12:30 p.m. Date: September 27, 2016.
Agenda: To review and evaluate grant
physician providers that administer applications.
Time: 12:00 p.m. to 2:00 p.m.
healthcare services to pregnant Agenda: To review and evaluate
Place: National Institutes of Health, Two
women, including pharmacists; and cooperative agreement applications.
Democracy Plaza, 6707 Democracy Blvd.,
—representatives from the private Place: National Institutes of Health, Two
Bethesda, MD 20892 (Telephone Conference
sector. Democracy Plaza, 6707 Democracy
Call).
Contact Person: Jian Yang, Ph.D., Scientific Boulevard, Bethesda, MD 20892 (Telephone
When responding, please self-identify Conference Call).
with any of the above or other categories Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room Contact Person: Najma Begum, Ph.D.,
(include all that apply) and your name. Scientific Review Officer, Review Branch,
7111, 6707 Democracy Boulevard, Bethesda,
Anonymous submissions will not be MD 20892–5452, (301) 594–7799, yangj@ DEA, NIDDK, National Institutes of Health,
considered. Written submissions should extra.niddk.nih.gov. Room 7349, 6707 Democracy Boulevard,
not exceed six (6) pages. Please do not Bethesda, MD 20892–5452, (301) 594–8894,
Name of Committee: National Institute of begumn@niddk.nih.gov.
send proprietary, commercial, financial, Diabetes and Digestive and Kidney Diseases
business, confidential, trade secret, or Special Emphasis Panel; Time-Sensitive (Catalogue of Federal Domestic Assistance
personal information. Obesity. Program Nos. 93.847, Diabetes,
Date: September 19, 2016. Endocrinology and Metabolic Research;
Dated: August 16, 2016. 93.848, Digestive Diseases and Nutrition
Time: 2:00 p.m. to 4:00 p.m.
Bruce Gellin, Agenda: To review and evaluate grant Research; 93.849, Kidney Diseases, Urology
Executive Secretary, National Vaccine applications. and Hematology Research, National Institutes
Advisory Committee, Deputy Assistant Place: National Institutes of Health, Two of Health, HHS)
Secretary for Health, Director, National Democracy Plaza, 6707 Democracy
Vaccine Program Office. Boulevard, Bethesda, MD 20892 (Telephone Dated: August 22, 2016.
[FR Doc. 2016–20525 Filed 8–25–16; 8:45 am] Conference Call). David Clary,
BILLING CODE 4150–44–P Contact Person: Michele L. Barnard, Ph.D., Program Analyst, Office of Federal Advisory
Scientific Review Officer, Review Branch, Committee Policy.
DEA, NIDDK, National Institutes of Health, [FR Doc. 2016–20446 Filed 8–25–16; 8:45 am]
Room 7353, 6707 Democracy Boulevard,
DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P
Bethesda, MD 20892–2542, (301) 594–8898,
HUMAN SERVICES barnardm@extra.niddk.nih.gov.
National Institutes of Health Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases DEPARTMENT OF HEALTH AND
Special Emphasis Panel; PAR–13–228: HUMAN SERVICES
National Institute of Diabetes and
Biomarkers for Diabetes, Digestive, Kidney
Digestive and Kidney Diseases; Notice and Urologic Diseases using NIDDK National Institutes of Health
of Closed Meetings Biorepository Samples (R01).
Date: September 21, 2016. National Institute of Diabetes and
Pursuant to section 10(d) of the Digestive and Kidney Diseases; Notice
Time: 12:00 p.m. to 3:00 p.m.
Federal Advisory Committee Act, as of Closed Meetings
Agenda: To review and evaluate grant
amended (5 U.S.C. App.), notice is applications.
hereby given of the following meetings. Place: National Institutes of Health, Two Pursuant to section 10(d) of the
The meetings will be closed to the Democracy Plaza, 6707 Democracy Federal Advisory Committee Act, as
public in accordance with the Boulevard, Bethesda, MD 20892 (Telephone amended (5 U.S.C. App.), notice is
provisions set forth in sections Conference Call). hereby given of the following meetings.
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Contact Person: Najma Begum, Ph.D., The meetings will be closed to the
as amended. The grant applications and Scientific Review Officer, Review Branch, public in accordance with the
the discussions could disclose DEA, NIDDK, National Institutes of Health, provisions set forth in sections
mstockstill on DSK3G9T082PROD with NOTICES

Room 7349, 6707 Democracy Boulevard,
confidential trade secrets or commercial Bethesda, MD 20892–5452, (301) 594–8894,
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
property such as patentable material, begumn@niddk.nih.gov. as amended. The grant applications and
and personal information concerning Name of Committee: National Institute of
the discussions could disclose
individuals associated with the grant Diabetes and Digestive and Kidney Diseases confidential trade secrets or commercial
applications, the disclosure of which Special Emphasis Panel; PAR–16–126: High property such as patentable material,
would constitute a clearly unwarranted Impact, Interdisciplinary Science in DDK and personal information concerning
invasion of personal privacy. Research Areas (RC2)–CKD. individuals associated with the grant

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Document Created: 2016-08-26 10:41:05
Document Modified: 2016-08-26 10:41:05

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 September 9, 2016.
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]
FR Citation		81 FR 58947