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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Five 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 

collection has changed since the last 

OMB approval. Because of a slight 

decrease in the number of blood 

establishments during the last 3 years, 

FDA has decreased our recordkeeping 

and third party disclosure burden 

estimates. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01123 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

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 clinicaldiagnoses); 

4. Access to Care Services and 

Support to Patients; 

5. Vaccine and Therapeutics; and 

6. Other Tick-Borne Diseases and Coinfections. 

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/advisorycommittees/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 tickbornedisease@

hhs.gov 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 

tickbornedisease@hhs.gov 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 tickbornedisease@

hhs.gov on or before February 7, 2018. 

Background and Authority: The TickBorne 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 tickborne 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] 

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