[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Proposed Rules]
[Pages 44253-44254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB14


National Vaccine Injury Compensation Program: Adding the Category 
of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table

AGENCY: Office of the Secretary, HHS.

ACTION: Notice of public hearing.

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SUMMARY: This document announces a public hearing to receive 
information and comments regarding the notice of proposed rulemaking 
(NPRM) titled ``National Vaccine Injury Compensation Program: Adding 
the Category of Vaccines Recommended for Pregnant Women to the Vaccine 
Injury Table.''

DATE AND TIME: September 17, 2018, from 10:00 a.m. to 11:30 a.m. ET.
    Location: 5600 Fishers Lane, Conference Room 08SWH01, Rockville, MD 
20857 (and via audio conference call and Adobe Connect).
    The public can join the hearing by:
    1. (In Person) The hearing will take place at 5600 Fishers Lane, 
Rockville, MD 20857. Persons interested in attending the hearing in 
person are encouraged to submit a written notification to: Ana Marie 
Balingit-Wines, Division of Injury Compensation Programs (DICP), 
Healthcare Systems Bureau (HSB), Health Resources and Services 
Administration (HRSA), Room 08N146B, 5600 Fishers Lane, Rockville, 
Maryland 20857 or email: <a href="/cdn-cgi/l/email-protection#b5d4d7d4d9dcdbd2dcc198c2dcdbd0c6f5ddc7c6d49bd2dac3"><span class="__cf_email__" data-cfemail="f4959695989d9a939d80d9839d9a9187b49c868795da939b82">[email protected]</span></a>. Since this hearing 
is held in a Federal government building, attendees must go through a 
security check to enter the building and participate in the meeting. A 
written notification is encouraged to make entry through security 
quicker. To request an escort during the hearing, call Ana Marie 
Balingit-Wines at 301-443-2030.
    2. (Audio Portion) Call the conference phone number 855-303-0062 
and provide the following information: Leader's Name: Dr. Narayan Nair, 
Password: 622245.
    3. (Visual Portion) Connect to the NPRM-Public Hearing Adobe 
Connect Pro Meeting using the following URL: https://hrsa.connectsolutions.com/nprm_public_hearing/ (copy and paste the link 
into your browser if it does not

[[Page 44254]]

work directly, and enter as a guest). Participants should call and 
connect 15 minutes prior to the meeting for logistics to be set up. If 
you have never attended an Adobe Connect meeting, please test your 
connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm and get a quick overview by 
following URL: http://www.adobe.com/go/connectpro_overview. Call (301) 
443-2030 or send an email to <a href="/cdn-cgi/l/email-protection#660704070a0f08010f124b110f080315260e14150748010910"><span class="__cf_email__" data-cfemail="e78685868b8e89808e93ca908e898294a78f959486c9808891">[email protected]</span></a> if you are having 
trouble connecting to the meeting site.

FOR FURTHER INFORMATION CONTACT: Dr. Narayan Nair, Director, Division 
of Injury Compensation Programs, at 800-338-2382 or by email: 
<a href="/cdn-cgi/l/email-protection#ff91919e968dbf978d8c9ed1989089"><span class="__cf_email__" data-cfemail="08666669617a48607a7b69266f677e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: As required by statute, the Secretary 
proposes to amend the Vaccine Injury Table (Table) by regulation to 
include vaccines recommended by the CDC for routine administration in 
pregnant women. The proposed rule, which was published in the Federal 
Register on April 4, 2018 (83 FR 14391; https://www.gpo.gov/fdsys/pkg/FR-2018-04-04/pdf/2018-06770.pdf), would amend the existing language in 
Item XVII of the Table to include ``and/or pregnant women'' after 
``children.'' This proposed revision would add to the general category 
of the Table any new vaccine recommended by the CDC for routine 
administration in pregnant women after imposition of an excise tax and 
publication of a notice of coverage. The Secretary is seeking public 
comment on the proposed revision to the Table. The public comment 
period for the NPRM closes on October 1, 2018.
    A public hearing on the NPRM will take place on September 17, 2018. 
This hearing is to provide an open forum for the presentation of 
information and views concerning the proposed revision to the Table by 
interested persons. In preparing a final regulation, the Secretary will 
consider the administrative record of this hearing along with all other 
written comments received during the comment period specified in the 
NPRM. The presiding officer, representing the Secretary of HHS, will be 
Dr. Narayan Nair, Director, Division of Injury Compensation Programs, 
Healthcare Systems Bureau, Health Resources and Services 
Administration.
    Individuals or representatives of interested organizations may 
participate in the public hearing in accordance with the following 
schedule and procedures. Persons who wish to participate should file a 
notice of participation with the Department of Health and Human 
Services (HHS) on or before September 3, 2018. The notice should be 
mailed to the Division of Injury Compensation Programs, Room 08N146B, 
5600 Fishers Lane, Rockville, Maryland 20857 or emailed to <a href="/cdn-cgi/l/email-protection#e8898a898481868f819cc59f81868d9ba8809a9b89c68f879e"><span class="__cf_email__" data-cfemail="3a5b585b5653545d534e174d53545f497a5248495b145d554c">[email protected]</span></a>. To ensure timely handling, any outer envelope or the 
subject line of an email should be clearly marked ``VICP NPRM 
Hearing.'' The notice of participation should contain the interested 
person's name, address, email address, telephone number, any business 
or organizational affiliation of the person desiring to make a 
presentation, a brief summary of the presentation, and the approximate 
time requested for the presentation. Groups that have similar interests 
should consolidate their comments as part of one presentation. Time 
available for the hearing will be allocated among the persons who 
properly file notices of participation. If time permits, interested 
parties attending the hearing who did not submit notice of 
participation in advance will be allowed to make an oral presentation 
at the conclusion of the hearing.
    Persons who find that there is insufficient time to submit the 
required information in writing may give oral notice of participation 
by calling Ana Marie Balingit-Wines, Division of Injury Compensation 
Programs, at (301) 443-2030, no later than September 3, 2018. After 
reviewing the notices of participation and accompanying information, 
HHS will schedule each appearance and notify each participant by mail, 
email, or telephone of the time allotted to the person(s) and the 
approximate time the person's oral presentation is scheduled to begin.
    Written comments and transcripts of the hearing will be made 
available for public inspection as soon as they have been prepared, on 
weekdays (except Federal holidays) between the hours of 8:30 a.m. and 
5:00 p.m. (EDT) at the Division of Injury Compensation Programs, Room 
08N146B, 5600 Fishers Lane, Rockville, Maryland 20857.

    Dated: August 24, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-18873 Filed 8-29-18; 8:45 am]
 BILLING CODE 4165-15-P


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