Availability of Set 29 Draft Toxicological Profiles, 37812-37813 [2018-16557]

Download as PDF 37812 Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices the adequate replacement test will likely proceed pursuant to the less rigorous alternative options test. The Commission estimates that the total annual burden of the entire collection, as revised, is reduced from 1,923 hours to 1,086 hours. Federal Communications Commission. Marlene Dortch, Secretary. Office of the Secretary. [FR Doc. 2018–16513 Filed 8–1–18; 8:45 am] BILLING CODE 6712–01–P FEDERAL ELECTION COMMISSION Sunshine Act Meeting Tuesday, August 7, 2018 at 10:00 a.m. PLACE: 1050 First Street NE, Washington, DC STATUS: This meeting will be closed to the public. MATTERS TO BE CONSIDERED: Compliance matters pursuant to 52 U.S.C. 30109. Matters relating to internal personnel decisions, or internal rules and practices. Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action. Matters concerning participation in civil actions or proceedings or arbitration. * * * * * CONTACT PERSON FOR MORE INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. TIME AND DATE: Dayna C. Brown, Secretary and Clerk of the Commission. [FR Doc. 2018–16700 Filed 7–31–18; 4:15 pm] BILLING CODE 6715–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [Docket No. ATSDR–2015–0001] Availability of Set 29 Draft Toxicological Profiles Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Notice of availability; request for comment. daltland on DSKBBV9HB2PROD with NOTICES AGENCY: The Agency for Toxic Substances and Disease Registry SUMMARY: VerDate Sep<11>2014 17:06 Aug 01, 2018 Jkt 244001 (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of Set 29 Draft Toxicological Profiles for review and comment. All toxicological profiles issued as ‘‘Drafts for Public Comment’’ represent ATSDR’s best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of Tribufos, Bromodichloromethane, Bromomethane, and 2-Hexanone for review and potential inclusion in the profiles. Although ATSDR considers key studies for these substances during the profile development process, this document solicits any relevant, additional information. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR also seeks comments on the organization and format of the Toxicological Profile for Bromodichloromethane. In an effort to improve the usability of the profiles, ATSDR recently made content and organizational changes based on user feedback, as well as data identifying the most used profile content. Changes include: Removing redundant content; adding summary figures and tables to Chapters 1, 2, 5, and 6 that did not exist in previous Toxicological Profiles; and reformatting the Levels of Significant Exposure (LSE) tables in Chapter 2. ATSDR has only applied the changes to the Draft Toxicological Profile for Bromodichloromethane, but intends to use the new format for future profiles. Specifically, ATSDR would like to know: (1) Does the chapter organization make it easier for you to find the information you need? For example, are you satisfied with the organization of the health effects chapter by organ system rather than exposure route? (2) Are the new tables and figures clear and useful? Do they make the Toxicological Profile easier to read? (3) If you have previously used any Toxicological Profile(s) for your work, which parts or content are the most useful to you, and what do you use it for? (4) Does the profile contain all of the information you need? If no, please elaborate on what additional information would be helpful. (5) Is there information you would like to see in the profile that is not currently included? If yes, please elaborate on the additional information you would like to see in the profile. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 ATSDR remains committed to providing a public comment period for these documents as a means to provide the best service to the public regarding public health. DATES: Comments must be submitted by October 31, 2018. ADDRESSES: You may submit comments, identified by docket number ATSDR– 2015–0001, by either of the following methods: • Internet: Access the Federal eRulemaking Portal at www.regulations.gov. Follow the instructions for submitting comments. • Mail: Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE, MS F–57, Atlanta, GA, 30329. Attn: Docket No. ATSDR– 2015–0001. Instructions: All submissions must include the agency name and docket number for this notice. All relevant comments will be posted without change. This means that no confidential business information or other confidential information should be submitted in response to this notice. The public comments, responses, and other data submitted in response to the Federal Register notices are available by request from ATSDR. Contact CDC Info at 1–800–232–4636 or cdcinfo@cdc.gov to request this information. FOR FURTHER INFORMATION CONTACT: Susan Ingber, Agency for Toxic Substances and Disease Registry, Division of Toxicology and Human Health Sciences, 1600 Clifton Rd. NE, MS F–57, Atlanta, GA, 30329, Email: ATSDRToxProfileFRNs@cdc.gov; Phone: 1–800–232–4636. SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9601 et seq.] amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) [42 U.S.C. 9601 et seq.] by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency (EPA) regarding hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL). Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the priority list of hazardous substances [also called the Substance Priority List (SPL)]. This list identifies 275 hazardous substances that ATSDR and EPA have determined pose the most significant potential threat to human health. The SPL is available online at www.atsdr.cdc.gov/spl. E:\FR\FM\02AUN1.SGM 02AUN1 Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 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 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. ACTION: 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 daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:06 Aug 01, 2018 Jkt 244001 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: PO 00000 Notice. Frm 00031 Fmt 4703 Sfmt 4703 37813 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: SUMMARY: 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 E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37812-37813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Docket No. ATSDR-2015-0001]


Availability of Set 29 Draft Toxicological Profiles

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice of availability; request for comment.

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

SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
within the Department of Health and Human Services (HHS) announces the 
availability of Set 29 Draft Toxicological Profiles for review and 
comment. All toxicological profiles issued as ``Drafts for Public 
Comment'' represent ATSDR's best efforts to provide important 
toxicological information on priority hazardous substances. ATSDR is 
seeking public comments and additional information or reports on 
studies about the health effects of Tribufos, Bromodichloromethane, 
Bromomethane, and 2-Hexanone for review and potential inclusion in the 
profiles. Although ATSDR considers key studies for these substances 
during the profile development process, this document solicits any 
relevant, additional information. ATSDR will evaluate the quality and 
relevance of such data or studies for possible inclusion into the 
profile.
    ATSDR also seeks comments on the organization and format of the 
Toxicological Profile for Bromodichloromethane. In an effort to improve 
the usability of the profiles, ATSDR recently made content and 
organizational changes based on user feedback, as well as data 
identifying the most used profile content. Changes include: Removing 
redundant content; adding summary figures and tables to Chapters 1, 2, 
5, and 6 that did not exist in previous Toxicological Profiles; and 
reformatting the Levels of Significant Exposure (LSE) tables in Chapter 
2. ATSDR has only applied the changes to the Draft Toxicological 
Profile for Bromodichloromethane, but intends to use the new format for 
future profiles. Specifically, ATSDR would like to know:
    (1) Does the chapter organization make it easier for you to find 
the information you need? For example, are you satisfied with the 
organization of the health effects chapter by organ system rather than 
exposure route?
    (2) Are the new tables and figures clear and useful? Do they make 
the Toxicological Profile easier to read?
    (3) If you have previously used any Toxicological Profile(s) for 
your work, which parts or content are the most useful to you, and what 
do you use it for?
    (4) Does the profile contain all of the information you need? If 
no, please elaborate on what additional information would be helpful.
    (5) Is there information you would like to see in the profile that 
is not currently included? If yes, please elaborate on the additional 
information you would like to see in the profile.
    ATSDR remains committed to providing a public comment period for 
these documents as a means to provide the best service to the public 
regarding public health.

DATES: Comments must be submitted by October 31, 2018.

ADDRESSES: You may submit comments, identified by docket number ATSDR-
2015-0001, by either of the following methods:
     Internet: Access the Federal eRulemaking Portal at 
www.regulations.gov. Follow the instructions for submitting comments.
     Mail: Division of Toxicology and Human Health Sciences, 
Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE, 
MS F-57, Atlanta, GA, 30329. Attn: Docket No. ATSDR-2015-0001.
    Instructions: All submissions must include the agency name and 
docket number for this notice. All relevant comments will be posted 
without change. This means that no confidential business information or 
other confidential information should be submitted in response to this 
notice. The public comments, responses, and other data submitted in 
response to the Federal Register notices are available by request from 
ATSDR. Contact CDC Info at 1-800-232-4636 or [email protected] to request 
this information.

FOR FURTHER INFORMATION CONTACT: Susan Ingber, Agency for Toxic 
Substances and Disease Registry, Division of Toxicology and Human 
Health Sciences, 1600 Clifton Rd. NE, MS F-57, Atlanta, GA, 30329, 
Email: [email protected]; Phone: 1-800-232-4636.

SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization 
Act of 1986 (SARA) [42 U.S.C. 9601 et seq.] amended the Comprehensive 
Environmental Response, Compensation, and Liability Act of 1980 (CERCLA 
or Superfund) [42 U.S.C. 9601 et seq.] by establishing certain 
requirements for ATSDR and the U.S. Environmental Protection Agency 
(EPA) regarding hazardous substances that are most commonly found at 
facilities on the CERCLA National Priorities List (NPL). Among these 
statutory requirements is a mandate for the Administrator of ATSDR to 
prepare toxicological profiles for each substance included on the 
priority list of hazardous substances [also called the Substance 
Priority List (SPL)]. This list identifies 275 hazardous substances 
that ATSDR and EPA have determined pose the most significant potential 
threat to human health. The SPL is available online at 
www.atsdr.cdc.gov/spl.

[[Page 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 site-specific 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