Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 37813 

In addition, CERCLA provides ATSDR 

with the authority to prepare 

toxicological profiles for substances not 

found on the SPL. CERCLA authorizes 

ATSDR to establish and maintain 

inventory of literature, research, and 

studies on the health effects of toxic 

substances (CERCLA Section 

104(i)(1)(B)); to respond to requests for 

health consultations (CERCLA Section 

104(i)(4)); and to support the sitespecific response actions conducted by 

the agency. 

Availability 

The Draft Toxicological Profiles are 

available online at http://

www.atsdr.cdc.gov/ToxProfiles and at 

www.regulations.gov, Docket No. 

ATSDR–2015–0001. 

Pamela I. Protzel Berman, 

Director, Office of Policy, Partnerships and 

Planning, Agency for Toxic Substances and 

Disease Registry. 

[FR Doc. 2018–16557 Filed 8–1–18; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Announce the Intent To Award an 

Administrative Supplement 

ACTION: Announcing the Intent to Award 

an Administrative Supplement for two 

(2) Help America Vote Act (HAVA) 

Training and Technical Assistance 

(T/TA) grantees, the National Disability 

Rights Network (NDRN) 90HAVA0001 

and the National Federation of the Blind 

(NFB) 90HAVA0002. 

SUMMARY: The Administration for 

Community Living (ACL) announces the 

intent to award an administrative 

supplement to the current Help America 

Vote Act (HAVA) Training and 

Technical Assistance (T/TA) grantees 

held by the National Disability Rights 

Network (NDRN) and the National 

Federation of the Blind (NFB). The 

purpose of the HAVA programs are 

designed to establish and improve 

participation in the election process for 

individuals with a full range of 

disabilities. In each eligible state and 

territory, seven percent of HAVA funds 

are set aside for the Protection and 

Advocacy Systems (P&As) to ensure that 

individuals with disabilities have the 

opportunity to participate in every step 

of the voting process. After receiving 

training and technical assistance, P&As 

may inform others on the availability of 

accessible voting equipment and its use. 

The administrative supplement for FY 

2018 will be in the amount of $122,721 

bringing the total award for FY 2018 to 

$462,590. 

Program Name: Help America Vote 

Act Training and Technical Assistance. 

Recipients: National Disability Rights 

Network (NDRN) and National 

Federation of the Blind (NFB). 

Period of Performance: The 

supplement award will be issued for the 

second year of the two-year project 

period of September 1, 2018, through 

August 30, 2019. 

Total Award Amount: NDRN 

$326,274 in FY 2018 NFB $136,316 in 

FY2018. 

Award Type: Administrative 

Supplement. 

Statutory Authority: This program is 

authorized under Title II, Subtitle D, 

Part 5 of HAVA 42 U.S.C. 15461–62, 

Section 102 of the Developmental 

Disabilities Assistance and Bill of Rights 

Act of 2000 (DD Act) (42 U.S.C. 15002). 

Basis for Award: The additional 

funding will not be used to begin new 

projects. The funding will be used to 

increase NDRN’s capacity building 

efforts to provide training and technical 

assistance to the Protection and 

Advocacy Systems in the electoral 

process and NFB will be able to attend 

voting related conferences, conduct 

voting outreach campaigns and translate 

materials into Spanish. 

FOR FURTHER INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Melvenia Wright, U.S. 

Department of Health and Human 

Services, Administration for 

Community Living, Administration on 

Disabilities, Administration on 

Intellectual and Developmental 

Disabilities: telephone (202) 795–7472; 

email Melvenia.Wright@acl.hhs.gov. 

Dated: July 26, 2018. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2018–16561 Filed 8–1–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0126] 

Revocation of Authorization of 

Emergency Use of an In Vitro 

Diagnostic Device for Detection of 

Ebola Virus 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to Zalgen Labs, LLC for the 

ReEBOV Antigen Rapid Test. FDA 

revoked this Authorization on May 18, 

2018, under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as requested 

by Zalgen Labs, LLC by letter dated 

March 1, 2018. The revocation, which 

includes an explanation of the reasons 

for revocation, is reprinted in this 

document. 

DATES: The Authorization is revoked as 

of May 18, 2018. 

ADDRESSES: Submit written requests for 

single copies of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a Fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4336, Silver Spring, MD 20993–0002, 

301–796–8510 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On 

February 24, 2015, FDA issued an EUA 

to Corgenix, Inc. for the ReEBOV 

Antigen Rapid Test, subject to the terms 

of the Authorization. Notice of the 

issuance of the Authorization was 

published in the Federal Register on 

June 5, 2015 (80 FR 32140), as required 

by section 564(h)(1) of the FD&C Act. In 

response to requests from Zalgen Labs, 

LLC and Corgenix, Inc. to transfer 

ownership of the EUA for the ReEBOV 

Antigen Rapid Test from Corgenix, Inc. 

to Zalgen Labs, LLC, FDA amended and 

reissued the EUA to Zalgen Labs, LLC 


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37814 Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 

in its entirety on November 3, 2016. 

Under section 564(g)(2), the Secretary of 

Health and Human Services may revoke 

an EUA if, among other things, the 

criteria for issuance are no longer met or 

other circumstances make such 

revocation appropriate to protect the 

public health or safety. 

II. EUA Revocation Request for an In 

Vitro Diagnostic Device for Detection of 

the Ebola Virus 

Pursuant to a request from Zalgen 

Labs, LLC on March 1, 2018, FDA 

revoked the EUA for the ReEBOV 

Antigen Rapid Test on May 18, 2018, 

because the criteria for issuance were no 

longer met and these circumstances 

made such revocation appropriate to 

protect the public health or safety. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocation are available on the internet 

at https://www.regulations.gov. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g) of the FD&C Act are met, 

FDA has revoked the EUA for Zalgen 

Labs, LLC’s ReEBOV Antigen Rapid 

Test. The revocation in its entirety 

follows and provides an explanation of 

the reasons for revocation, as required 

by section 564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


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37816 Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 

Dated: July 27, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16537 Filed 8–1–18; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2657] 

Advancing the Development of 

Pediatric Therapeutics 5: Advancing 

Pediatric Pharmacovigilance; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Division of Pediatric and 

Maternal Health, Office of Surveillance 

and Epidemiology, and Office of 

Pediatric Therapeutics, Food and Drug 

Administration (FDA or the Agency) are 

announcing a public workshop entitled 

‘‘Advancing the Development of 

Pediatric Therapeutics 5: Advancing 

Pediatric Pharmacovigilance.’’ The 

purpose of this 1-day workshop is to 

provide a forum to gather information 

on the latest developments in pediatric 

pharmacovigilance from the perspective 

of various stakeholders and to expand 

the conversation to include the utility 

and challenges of emerging 

pharmacovigilance tools, including 

specific challenges associated with 

pediatric data tools. 

DATES: The public workshop will be 

held on Friday, September 14, 2018, 

from 8 a.m. to 5 p.m. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at FDAWhite Oak Campus, 

10903 New Hampshire Ave. Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: For 

questions regarding the workshop, 

contact Denise Pica-Branco, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–1732, 

denise.picabranco@fda.hhs.gov; or 

Meshaun Payne, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–6668, 

meshaun.payne@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Drugs and biologics (products) receive 

marketing approval only after 

undergoing premarket review and upon 

establishment of safety and efficacy 

through adequate and well-controlled 

clinical trials. Because all safety issues 

related to a product may not be detected 

in the premarket phase, FDA receives 

and analyzes postmarket safety 

information to determine if events 

reported in the postmarketing period are 

likely to be related to exposure to a 

product. When FDA determines that 

reported postmarketing events are likely 

related to a product, FDA can introduce 

labeling changes and other activities to 

inform the professional and lay public. 


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