83_FR_3186 83 FR 3171 - Meeting of the Tick-Borne Disease Working Group

83 FR 3171 - Meeting of the Tick-Borne Disease Working Group

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 15 (January 23, 2018)

Page Range3171-3171
FR Document2018-01149

The Department of Health and Human Services (HHS) announces the third meeting of the Tick-Borne Disease Working Group (Working Group) on February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time. For this third meeting, the Working Group will focus on mapping out the work of the six Subcommittee Meeting Working Groups that were established on December 12, 2017. These subcommittees were established to assist the Working Group with the development of the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees are: 1. Disease Vectors, Surveillance and Prevention (includes epidemiology of tick-borne diseases); 2. Pathogenesis, Transmission, and Treatment; 3. Testing and Diagnostics (including laboratory-based diagnoses and clinical-diagnoses); 4. Access to Care Services and Support to Patients; 5. Vaccine and Therapeutics; and 6. Other Tick-Borne Diseases and Co-infections.

Federal Register, Volume 83 Issue 15 (Tuesday, January 23, 2018)
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Page 3171]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Tick-Borne Disease Working Group

AGENCY: Office of HIV/AIDS and Infectious Disease Policy, Office of the 
Assistant Secretary for Health, Office of the Secretary, Department of 
Health and Human Services.

ACTION: Notice.

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

SUMMARY: The Department of Health and Human Services (HHS) announces 
the third meeting of the Tick-Borne Disease Working Group (Working 
Group) on February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern 
Time. For this third meeting, the Working Group will focus on mapping 
out the work of the six Subcommittee Meeting Working Groups that were 
established on December 12, 2017. These subcommittees were established 
to assist the Working Group with the development of the report to 
Congress and the HHS Secretary as required by the 21st Century Cures 
Act. The subcommittees are:
    1. Disease Vectors, Surveillance and Prevention (includes 
epidemiology of tick-borne diseases);
    2. Pathogenesis, Transmission, and Treatment;
    3. Testing and Diagnostics (including laboratory-based diagnoses 
and clinical-diagnoses);
    4. Access to Care Services and Support to Patients;
    5. Vaccine and Therapeutics; and
    6. Other Tick-Borne Diseases and Co-infections.

DATES: February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time.

ADDRESSES: This will be a virtual meeting that is held via webcast. 
Members of the public may attend the meeting via webcast and 
instructions for attending this virtual meeting will be posted one week 
prior to the meeting at: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html.

FOR FURTHER INFORMATION CONTACT: James Berger, Office of HIV/AIDS and 
Infectious Disease Policy, Office of the Assistant Secretary for 
Health, Department of Health and Human Services; via email at 
[email protected] or by phone at 202-795-7697.

SUPPLEMENTARY INFORMATION: At this meeting, the Working Group will also 
hear about one or more examples of other efforts that have been 
successfully undertaken to define a national or statewide approach to 
preventing, monitoring, diagnosing, and treating people with tick-borne 
diseases. In addition, federal resources, within and outside of HHS, 
that may be of use to the subcommittees as they do their work, such as 
the Department of Health and Human Services Internal Working Group on 
Lyme and Other Tick-Borne Diseases, will be presented.
    The Working Group invites public comment on issues related to the 
Working Group's charge. Comments may be provided over the phone during 
the meeting or in writing. Persons who wish to provide comments by 
phone should review directions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/index.html before submitting a 
request via email at [email protected] on or before February 7, 
2018. Phone comments will be limited to three minutes each to 
accommodate as many speakers as possible. A total of 30 minutes will be 
allocated to public comments. If more requests are received than can be 
accommodated, speakers will be randomly selected. The nature of the 
comments will not be considered in making this selection. Public 
comments may also be provided in writing. Individuals who would like to 
provide written comment should review directions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/index.html before sending their comments to [email protected] on 
or before February 7, 2018.
    Background and Authority: The Tick-Borne Disease Working Group was 
established on August 10, 2017, in accordance with section 2062 of the 
21st Century Cures Act, and the Federal Advisory Committee Act, 5 
U.S.C. App., as amended, to provide expertise and review all HHS 
efforts related to tick-borne diseases to help ensure interagency 
coordination and minimize overlap, examine research priorities, and 
identify and address unmet needs. In addition, the Working Group will 
report to the Secretary and Congress on their findings and any 
recommendations for the federal response to tick-borne disease 
prevention, treatment and research, and addressing gaps in those areas.

    Dated: January 17, 2018.
James Berger,
Alternate Designated Federal Officer, Office of HIV/AIDS and Infectious 
Disease Policy, Tick-Borne Disease Working Group.
[FR Doc. 2018-01149 Filed 1-22-18; 8:45 am]
 BILLING CODE 4150-28-P



                                                                                       Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices                                                                                               3171

                                                                                    TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
                                                                                                                                                                  Number of                      Total                        Average
                                                                                                                                       Number of
                                                                            21 CFR section                                                                      responses per                   annual                      burden per                  Total hours
                                                                                                                                      respondents                 respondent                  responses                      response

                                                610.47(a)(3) ..................................................................                     1,734                 11.7630                      20,397         .17 (10 min.) .........                  3,467
                                                610.47(b)(3) ..................................................................                     4,961                  0.4132                       2,050         1 ............................           2,050
                                                630.40(a) 3 ....................................................................                      578                 742.214                     429,000         .08 (5 min.) ...........                34,320
                                                630.40(a) 4 ....................................................................                       81                   50.00                       4,050         1.5 .........................            6,075
                                                630.40(d)(1) ..................................................................                        53                   11.83                         627         1 ............................             627

                                                      Total ......................................................................   ........................   ........................   ........................   ...............................         57,701
                                                   1 There are no capital costs or operating and maintenance costs associated with this collection of information.
                                                   2 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 ×
                                                4,961 + 2,303 = 363).
                                                  3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
                                                  4 Notification of donors deferred based on reactive test results for evidence of infection due to relevant transfusion-transmitted infections.




                                                  The burden for this information                                            3. Testing and Diagnostics (including                                    before submitting a request via email at
                                                collection has changed since the last                                     laboratory-based diagnoses and clinical-                                    tickbornedisease@hhs.gov on or before
                                                OMB approval. Because of a slight                                         diagnoses);                                                                 February 7, 2018. Phone comments will
                                                decrease in the number of blood                                              4. Access to Care Services and                                           be limited to three minutes each to
                                                establishments during the last 3 years,                                   Support to Patients;                                                        accommodate as many speakers as
                                                FDA has decreased our recordkeeping                                          5. Vaccine and Therapeutics; and                                         possible. A total of 30 minutes will be
                                                and third party disclosure burden                                            6. Other Tick-Borne Diseases and Co-
                                                                                                                                                                                                      allocated to public comments. If more
                                                estimates.                                                                infections.
                                                                                                                                                                                                      requests are received than can be
                                                                                                                          DATES: February 12, 2018, from 12:00
                                                  Dated: January 17, 2018.                                                                                                                            accommodated, speakers will be
                                                                                                                          p.m. to 4:00 p.m., Eastern Time.
                                                Leslie Kux,                                                                                                                                           randomly selected. The nature of the
                                                                                                                          ADDRESSES: This will be a virtual
                                                Associate Commissioner for Policy.                                                                                                                    comments will not be considered in
                                                                                                                          meeting that is held via webcast.
                                                [FR Doc. 2018–01123 Filed 1–22–18; 8:45 am]                                                                                                           making this selection. Public comments
                                                                                                                          Members of the public may attend the
                                                BILLING CODE 4164–01–P                                                    meeting via webcast and instructions for                                    may also be provided in writing.
                                                                                                                          attending this virtual meeting will be                                      Individuals who would like to provide
                                                                                                                          posted one week prior to the meeting at:                                    written comment should review
                                                DEPARTMENT OF HEALTH AND                                                  https://www.hhs.gov/ash/advisory-                                           directions at https://www.hhs.gov/ash/
                                                HUMAN SERVICES                                                            committees/tickbornedisease/                                                advisory-committees/tickbornedisease/
                                                                                                                          index.html.                                                                 meetings/index.html before sending
                                                Meeting of the Tick-Borne Disease                                                                                                                     their comments to tickbornedisease@
                                                Working Group                                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                                          James Berger, Office of HIV/AIDS and                                        hhs.gov on or before February 7, 2018.
                                                AGENCY:  Office of HIV/AIDS and                                           Infectious Disease Policy, Office of the                                       Background and Authority: The Tick-
                                                Infectious Disease Policy, Office of the                                  Assistant Secretary for Health,                                             Borne Disease Working Group was
                                                Assistant Secretary for Health, Office of                                 Department of Health and Human                                              established on August 10, 2017, in
                                                the Secretary, Department of Health and                                   Services; via email at tickbornedisease@                                    accordance with section 2062 of the 21st
                                                Human Services.                                                           hhs.gov or by phone at 202–795–7697.                                        Century Cures Act, and the Federal
                                                                                                                          SUPPLEMENTARY INFORMATION: At this                                          Advisory Committee Act, 5 U.S.C. App.,
                                                ACTION:      Notice.
                                                                                                                          meeting, the Working Group will also                                        as amended, to provide expertise and
                                                SUMMARY:   The Department of Health and                                   hear about one or more examples of                                          review all HHS efforts related to tick-
                                                Human Services (HHS) announces the                                        other efforts that have been successfully                                   borne diseases to help ensure
                                                third meeting of the Tick-Borne Disease                                   undertaken to define a national or                                          interagency coordination and minimize
                                                Working Group (Working Group) on                                          statewide approach to preventing,                                           overlap, examine research priorities,
                                                February 12, 2018, from 12:00 p.m. to                                     monitoring, diagnosing, and treating                                        and identify and address unmet needs.
                                                4:00 p.m., Eastern Time. For this third                                   people with tick-borne diseases. In                                         In addition, the Working Group will
                                                meeting, the Working Group will focus                                     addition, federal resources, within and                                     report to the Secretary and Congress on
                                                on mapping out the work of the six                                        outside of HHS, that may be of use to                                       their findings and any recommendations
                                                Subcommittee Meeting Working Groups                                       the subcommittees as they do their
                                                                                                                                                                                                      for the federal response to tick-borne
                                                that were established on December 12,                                     work, such as the Department of Health
                                                                                                                                                                                                      disease prevention, treatment and
                                                2017. These subcommittees were                                            and Human Services Internal Working
                                                                                                                          Group on Lyme and Other Tick-Borne                                          research, and addressing gaps in those
                                                established to assist the Working Group                                                                                                               areas.
                                                with the development of the report to                                     Diseases, will be presented.
                                                                                                                             The Working Group invites public                                            Dated: January 17, 2018.
                                                Congress and the HHS Secretary as
                                                                                                                          comment on issues related to the
sradovich on DSK3GMQ082PROD with NOTICES




                                                required by the 21st Century Cures Act.                                                                                                               James Berger,
                                                                                                                          Working Group’s charge. Comments                                            Alternate Designated Federal Officer, Office
                                                The subcommittees are:
                                                                                                                          may be provided over the phone during                                       of HIV/AIDS and Infectious Disease Policy,
                                                   1. Disease Vectors, Surveillance and                                   the meeting or in writing. Persons who                                      Tick-Borne Disease Working Group.
                                                Prevention (includes epidemiology of                                      wish to provide comments by phone
                                                tick-borne diseases);                                                                                                                                 [FR Doc. 2018–01149 Filed 1–22–18; 8:45 am]
                                                                                                                          should review directions at https://
                                                                                                                                                                                                      BILLING CODE 4150–28–P
                                                   2. Pathogenesis, Transmission, and                                     www.hhs.gov/ash/advisory-committees/
                                                Treatment;                                                                tickbornedisease/meetings/index.html


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Document Created: 2018-01-23 01:09:03
Document Modified: 2018-01-23 01:09:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFebruary 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time.
ContactJames Berger, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services; via email at [email protected] or by phone at 202-795-7697.
FR Citation83 FR 3171 

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