83_FR_44422 83 FR 44253 - National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table

83 FR 44253 - National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 169 (August 30, 2018)

Page Range44253-44254
FR Document2018-18873

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.''

Federal Register, Volume 83 Issue 169 (Thursday, August 30, 2018)
[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Proposed Rules]
[Pages 44253-44254]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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: [email protected]. 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 [email protected] 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: 
[email protected].

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.thefederalregister.org/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 [email protected]. 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



                                                                      Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Proposed Rules                                                44253

                                                communities on federal lands (the                       of the EIS. Federally recognized Tribes                 Dated: August 24, 2018.
                                                Tongass National Forest comprises                       within the Tongass National Forest have               Christopher B. French,
                                                almost 80% of southeast Alaska); as                     been invited to participate as a                      Acting Deputy Chief.
                                                well as Alaska and Tongass National                     cooperating agency.                                   [FR Doc. 2018–18937 Filed 8–29–18; 8:45 am]
                                                Forest-specific statutory considerations                                                                      BILLING CODE 3411–15–P
                                                (e.g., Alaska National Interest Lands                   Responsible Official
                                                Conservation Act (ANILCA), Tongass                        The Responsible Official for the
                                                Timber Reform Act (TTRA)).                                                                                    DEPARTMENT OF HEALTH AND
                                                                                                        rulemaking and EIS is the Secretary of
                                                   The Department and Forest Service
                                                                                                        Agriculture or his designee.                          HUMAN SERVICES
                                                believe that current timber harvest and
                                                road construction/reconstruction                        Decision To Be Made                                   42 CFR Part 100
                                                restrictions can be adjusted for the
                                                Tongass National Forest in a manner                       The Responsible Official will                       RIN 0906–AB14
                                                that meaningfully addresses local                       determine appropriate management
                                                economic and development concerns                       direction for roadless areas within the               National Vaccine Injury Compensation
                                                while balancing roadless area                           State of Alaska, including appropriate                Program: Adding the Category of
                                                conservation needs.                                                                                           Vaccines Recommended for Pregnant
                                                                                                        exceptions to address essential
                                                   The State of Alaska believes that                                                                          Women to the Vaccine Injury Table
                                                                                                        infrastructure, timber, energy, mining,
                                                roadless conservation interests for the                 access, and transportation systems                    AGENCY:   Office of the Secretary, HHS.
                                                Tongass National Forest can be                          necessary to further Alaska’s economic                ACTION:   Notice of public hearing.
                                                adequately protected under the Tongass                  development interests, while at the
                                                Land Management Plan and that the                       same time conserving roadless areas in                SUMMARY:    This document announces a
                                                2001 Roadless Rule prohibitions are                     Alaska for generations to come.                       public hearing to receive information
                                                unnecessary. In addition, the State                                                                           and comments regarding the notice of
                                                believes application of the 2001                        Scoping Process                                       proposed rulemaking (NPRM) titled
                                                Roadless Rule substantially impacts the                                                                       ‘‘National Vaccine Injury Compensation
                                                social and economic fabric of southeast                    This Notice of Intent initiates the
                                                                                                                                                              Program: Adding the Category of
                                                Alaska and violates ANILCA and TTRA.                    scoping process in compliance with the
                                                                                                                                                              Vaccines Recommended for Pregnant
                                                   In response to the State’s petition,                 National Environmental Policy Act and                 Women to the Vaccine Injury Table.’’
                                                commercial and non-profit                               its implementing regulations (40 CFR
                                                                                                                                                              DATE AND TIME: September 17, 2018,
                                                organizations have expressed strong                     part 1500–1508). As part of the scoping
                                                                                                                                                              from 10:00 a.m. to 11:30 a.m. ET.
                                                opinions, for and against, the idea of a                period, the Forest Service, on behalf of
                                                                                                                                                                 Location: 5600 Fishers Lane,
                                                regulatory review.                                      the Department, solicits public
                                                                                                                                                              Conference Room 08SWH01, Rockville,
                                                                                                        comment on the nature and scope of the
                                                Proposed Action                                                                                               MD 20857 (and via audio conference
                                                                                                        environmental, social, and economic
                                                  The Department proposes to develop                                                                          call and Adobe Connect).
                                                                                                        issues related to Alaska-specific                        The public can join the hearing by:
                                                a durable and long-lasting regulation for               rulemaking that should be analyzed in
                                                the conservation and management of                                                                               1. (In Person) The hearing will take
                                                                                                        depth in the Draft EIS.                               place at 5600 Fishers Lane, Rockville,
                                                roadless areas on the Tongass National
                                                Forest. The state-specific roadless rule                   Comments collected during scoping of               MD 20857. Persons interested in
                                                would establish a land classification                   the Alaska-specific rulemaking will be                attending the hearing in person are
                                                system designed to conserve roadless                    used to refine the proposed action,                   encouraged to submit a written
                                                area characteristics on the Tongass                     define the scope of the analysis, and                 notification to: Ana Marie Balingit-
                                                National Forest while accommodating                     develop alternatives to the proposed                  Wines, Division of Injury Compensation
                                                timber harvesting and road                              action if needed. Public meetings are                 Programs (DICP), Healthcare Systems
                                                construction/reconstruction activities                  planned to be held in Juneau                          Bureau (HSB), Health Resources and
                                                that are determined to be needed for                    (September 13, 2018), Ketchikan                       Services Administration (HRSA), Room
                                                forest management, economic                             (September 17, 2018), Hoonah                          08N146B, 5600 Fishers Lane, Rockville,
                                                development opportunities, and the                      (September 17, 2018), Craig (September                Maryland 20857 or email: abalingit-
                                                exercise of valid existing rights or other              18, 2018), Angoon (September 18, 2018),               wines@hrsa.gov. Since this hearing is
                                                non-discretionary legal authorities.                    Point Baker/Port Protection (September                held in a Federal government building,
                                                                                                        19, 2018), Wrangell (September 24,                    attendees must go through a security
                                                Alternatives to the Proposed Action                                                                           check to enter the building and
                                                                                                        2018), Sitka (September 24, 2018),
                                                   The other alternatives being                         Petersburg (September 25, 2018),                      participate in the meeting. A written
                                                considered at this time are the no-action               Yakutat (September 25, 2018), Kake                    notification is encouraged to make entry
                                                alternative, which is the continuation of               (September 26, 2018), and Anchorage                   through security quicker. To request an
                                                current management of the Tongass                                                                             escort during the hearing, call Ana
                                                                                                        (September 26, 2018), and Washington
                                                National Forest in Alaska in accordance                                                                       Marie Balingit-Wines at 301–443–2030.
                                                                                                        DC (date to be determined). Additional
                                                with the 2001 Roadless Rule, and an                                                                              2. (Audio Portion) Call the conference
                                                                                                        information on meeting times and
                                                alternative that would exempt the                                                                             phone number 855–303–0062 and
                                                                                                        locations will be provided through the
                                                Tongass National Forest from the                                                                              provide the following information:
amozie on DSK3GDR082PROD with PROPOSALS1




                                                                                                        project website and local media.                      Leader’s Name: Dr. Narayan Nair,
                                                provisions of that 2001 Roadless Rule,
                                                but leave current management under the                  Estimated Timeline                                    Password: 622245.
                                                2001 Roadless Rule in place on the                                                                               3. (Visual Portion) Connect to the
                                                Chugach National Forest.                                  The Draft EIS and proposed rule are                 NPRM-Public Hearing Adobe Connect
                                                                                                        estimated to be released in early                     Pro Meeting using the following URL:
                                                Cooperating Agencies                                    summer 2019. The Final EIS is                         https://hrsa.connectsolutions.com/
                                                  The State of Alaska will participate as               estimated to be released in spring 2020,              nprm_public_hearing/ (copy and paste
                                                a cooperating agency in the preparation                 with a final rule expected in June 2020.              the link into your browser if it does not


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                                                44254                 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Proposed Rules

                                                work directly, and enter as a guest).                   Services (HHS) on or before September                 FEDERAL COMMUNICATIONS
                                                Participants should call and connect 15                 3, 2018. The notice should be mailed to               COMMISSION
                                                minutes prior to the meeting for                        the Division of Injury Compensation
                                                logistics to be set up. If you have never               Programs, Room 08N146B, 5600 Fishers                  47 CFR Part 54
                                                attended an Adobe Connect meeting,                      Lane, Rockville, Maryland 20857 or                    [WC Docket No. 10–90, WT Docket No. 10–
                                                please test your connection using the                   emailed to abalingit-wines@hrsa.gov. To               208; FCC 18–124]
                                                following URL: https://                                 ensure timely handling, any outer
                                                hrsa.connectsolutions.com/common/                       envelope or the subject line of an email              Connect America Fund; Universal
                                                help/en/support/meeting_test.htm and                    should be clearly marked ‘‘VICP NPRM                  Service Reform—Mobility Fund
                                                get a quick overview by following URL:                  Hearing.’’ The notice of participation
                                                http://www.adobe.com/go/connectpro_                                                                           AGENCY:  Federal Communications
                                                                                                        should contain the interested person’s                Commission.
                                                overview. Call (301) 443–2030 or send                   name, address, email address, telephone
                                                an email to abalingit-wines@hrsa.gov if                                                                       ACTION: Proposed rule.
                                                                                                        number, any business or organizational
                                                you are having trouble connecting to the
                                                                                                        affiliation of the person desiring to make            SUMMARY:    This document proposes
                                                meeting site.
                                                                                                        a presentation, a brief summary of the                modifying the timeframe for collecting
                                                FOR FURTHER INFORMATION CONTACT: Dr.                                                                          acceptable speed test data in support of
                                                                                                        presentation, and the approximate time
                                                Narayan Nair, Director, Division of                                                                           Mobility Fund II eligibility challenges,
                                                                                                        requested for the presentation. Groups
                                                Injury Compensation Programs, at 800–                                                                         such that acceptable data may be
                                                                                                        that have similar interests should
                                                338–2382 or by email: nnair@hrsa.gov.                                                                         collected at any time on or after
                                                                                                        consolidate their comments as part of
                                                SUPPLEMENTARY INFORMATION: As                                                                                 February 27, 2018, until November 26,
                                                                                                        one presentation. Time available for the
                                                required by statute, the Secretary                                                                            2018.
                                                                                                        hearing will be allocated among the
                                                proposes to amend the Vaccine Injury                                                                          DATES: Comments are due September
                                                                                                        persons who properly file notices of
                                                Table (Table) by regulation to include                                                                        10, 2018, and reply comments are due
                                                vaccines recommended by the CDC for                     participation. If time permits, interested
                                                                                                        parties attending the hearing who did                 by September 14, 2018.
                                                routine administration in pregnant
                                                                                                        not submit notice of participation in                 ADDRESSES: You may submit comments,
                                                women. The proposed rule, which was
                                                published in the Federal Register on                    advance will be allowed to make an oral               identified by WC Docket No. 10–90 and
                                                April 4, 2018 (83 FR 14391; https://                    presentation at the conclusion of the                 WT Docket No. 10–208, by any of the
                                                www.gpo.gov/fdsys/pkg/FR-2018-04-04/                    hearing.                                              following methods:
                                                pdf/2018-06770.pdf), would amend the                                                                            • Federal eRulemaking Portal: http://
                                                                                                           Persons who find that there is
                                                existing language in Item XVII of the                                                                         www.regulations.gov. Follow the
                                                                                                        insufficient time to submit the required              instructions for submitting comments.
                                                Table to include ‘‘and/or pregnant                      information in writing may give oral                    • Federal Communications
                                                women’’ after ‘‘children.’’ This                        notice of participation by calling Ana                Commission’s Website: https://
                                                proposed revision would add to the                      Marie Balingit-Wines, Division of Injury              www.fcc.gov/ecfs/. Follow the
                                                general category of the Table any new                   Compensation Programs, at (301) 443–                  instructions for submitting comments.
                                                vaccine recommended by the CDC for                      2030, no later than September 3, 2018.                  • People with Disabilities: Contact the
                                                routine administration in pregnant                      After reviewing the notices of                        FCC to request reasonable
                                                women after imposition of an excise tax                 participation and accompanying                        accommodations (accessible format
                                                and publication of a notice of coverage.
                                                                                                        information, HHS will schedule each                   documents, sign language interpreters,
                                                The Secretary is seeking public
                                                                                                        appearance and notify each participant                CART, etc.) by email: FCC504@fcc.gov,
                                                comment on the proposed revision to
                                                                                                        by mail, email, or telephone of the time              phone: 202–418–0530 or TTY: 202–418–
                                                the Table. The public comment period
                                                                                                        allotted to the person(s) and the                     0432.
                                                for the NPRM closes on October 1, 2018.
                                                   A public hearing on the NPRM will                    approximate time the person’s oral                    FOR FURTHER INFORMATION CONTACT:
                                                take place on September 17, 2018. This                  presentation is scheduled to begin.                   Wireless Telecommunications Bureau,
                                                hearing is to provide an open forum for                    Written comments and transcripts of                Auctions and Spectrum Access
                                                the presentation of information and                     the hearing will be made available for                Division, Audra Hale-Maddox, at (202)
                                                views concerning the proposed revision                  public inspection as soon as they have                418–0660.
                                                to the Table by interested persons. In                  been prepared, on weekdays (except                    SUPPLEMENTARY INFORMATION: This is a
                                                preparing a final regulation, the                       Federal holidays) between the hours of                summary of the Commission’s Notice of
                                                Secretary will consider the                             8:30 a.m. and 5:00 p.m. (EDT) at the                  Proposed Rulemaking (NPRM), WC
                                                administrative record of this hearing                   Division of Injury Compensation                       Docket No. 10–90 and WT Docket No.
                                                along with all other written comments                   Programs, Room 08N146B, 5600 Fishers                  10–208, FCC 18–124, adopted on
                                                received during the comment period                      Lane, Rockville, Maryland 20857.                      August 14, 2018, and released on
                                                specified in the NPRM. The presiding                                                                          August 21, 2018. The complete text of
                                                officer, representing the Secretary of                    Dated: August 24, 2018.                             this document is available for public
                                                HHS, will be Dr. Narayan Nair, Director,                Alex M. Azar II,                                      inspection and copying from 8 a.m. to
                                                Division of Injury Compensation                         Secretary, Department of Health and Human             4:30 p.m. Eastern Time (ET) Monday
                                                Programs, Healthcare Systems Bureau,                    Services.                                             through Thursday or from 8 a.m. to
                                                Health Resources and Services                           [FR Doc. 2018–18873 Filed 8–29–18; 8:45 am]           11:30 a.m. ET on Fridays in the FCC
amozie on DSK3GDR082PROD with PROPOSALS1




                                                Administration.                                         BILLING CODE 4165–15–P
                                                                                                                                                              Reference Information Center, 445 12th
                                                   Individuals or representatives of                                                                          Street SW, Room CY–A257,
                                                interested organizations may participate                                                                      Washington, DC 20554. The complete
                                                in the public hearing in accordance with                                                                      text is also available on the
                                                the following schedule and procedures.                                                                        Commission’s website at http://
                                                Persons who wish to participate should                                                                        wireless.fcc.gov, or by using the search
                                                file a notice of participation with the                                                                       function on the ECFS web page at
                                                Department of Health and Human                                                                                http://www.fcc.gov/cgb/ecfs/.


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Document Created: 2018-08-30 01:21:14
Document Modified: 2018-08-30 01:21:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of public hearing.
ContactDr. Narayan Nair, Director, Division of Injury Compensation Programs, at 800-338-2382 or by email: [email protected]
FR Citation83 FR 44253 
RIN Number0906-AB14

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