Proposed Substances To Be Evaluated for Toxicological Profile Development, 16511-16512 [2019-07916]

Download as PDF Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices • Committee comments • Next steps DEPARTMENT OF HEALTH AND HUMAN SERVICES Biweekly Task Group Conference Calls Agency for Toxic Substances and Disease Registry These meetings allow the Task Groups to develop consensus recommendations to the Committee, which will, in turn, decide whether to proceed with formal advice to GSA based upon these recommendations. The Building and Grid Integration Task Group, Phase II continues to build on the recommendations of the first phase of this Task Group, posted at https://www.gsa.gov/cdnstatic/ Bldg%20Grid%20Integration% 20Advice%20Letter%202-21-19%20%20508.pdf, to prioritize federal building and grid integration strategies and develop implementation plans and scenarios with future rate structures, including consideration of electronic vehicles (EVs) and energy storage. The Data-Integrated Building Systems Task Group continues to document and recognize data-integrated building system (e.g., smart building system) use cases that demonstrate the business case and quantify the multiple benefits of integrating building technologies and systems. In-Person Meeting The Committee meeting will convene experts in buildings, including architects, material suppliers, construction contractors, environment, health, security and transportation to accelerate the successful transformation of the Federal building portfolio to sustainable technologies and practices. The Meeting provides the venue for the Building-grid integration and Dataintegrated building systems Task Groups to present their findings and recommendations. This full Committee meeting is being rescheduled from May 16, 2019 (Federal Register/Vol. 83, No. 65166). khammond on DSKBBV9HB2PROD with NOTICES In-Person Meeting Agenda • Updates and introductions • Building-grid integration task group findings & recommendations • Lunchtime speaker (TBD) • Data-integrated building systems task group findings & recommendations • Additional topics proposed by Committee members • Public comment • Next steps and closing comments Kevin Kampschroer, Federal Director, Office of Federal HighPerformance Buildings, General Services Administration. [FR Doc. 2019–07865 Filed 4–18–19; 8:45 am] BILLING CODE 6820–14–P VerDate Sep<11>2014 16:23 Apr 18, 2019 Jkt 247001 [Docket No. ATSDR–2019–0005] Proposed Substances To Be Evaluated for Toxicological Profile Development Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Request for comments on proposed substances to be evaluated for Toxicological Profile development. AGENCY: The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List (available at https://www.atsdr.cdc.gov/SPL/). ATSDR also accepts nominations for non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR’s authority to prepare Toxicological Profiles for substances not found at sites on the CERCLA National Priorities List. For more information on the CERCLA National Priorities List, visit https:// www.epa.gov/superfund/superfundnational-priorities-list-npl. The agency will do so in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary. DATES: Nominations from the Substance Priority List and/or additional substances must be received by May 20, 2019. ADDRESSES: You may submit nominations, identified by Docket No. ATSDR–2019–0005, by any 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, Mail Stop S102–1, Atlanta, GA, 30329–4027. Attn: Docket No. ATSDR–201x–xxxx. SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 16511 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. Refer to the section Submission of Nominations (below) for the specific information required. FOR FURTHER INFORMATION CONTACT: For further information, please contact Susan Ingber, Agency for Toxic Substances and Disease Registry, Division of Toxicology and Human Health Sciences, 1600 Clifton Rd. NE, Mail Stop S102–1, Atlanta, GA, 30329– 4027, 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) with regard to hazardous substances most commonly found at facilities on the CERCLA National Priorities List (NPL) (for more information, visit https://www.epa.gov/ superfund/superfund-nationalpriorities-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 known as the Substance Priority list (SPL)). This list identifies 275 hazardous substances found at NPL sites that ATSDR and EPA have determined pose the most significant current potential threat to human health. Substances To Be Evaluated for Toxicological Profile Development Each year, ATSDR develops a list of substances to be considered for Toxicological Profile development. The nomination process includes consideration of all substances on ATSDR’s SPL, as well as other substances nominated by the public. For more information on ATSDR’s SPL, visit https://www.atsdr.cdc.gov/SPL/. Submission of nominations for Toxicological Profile development: Today’s notice invites voluntary public nominations for substances included on the SPL and for substances not listed on the SPL. All nominations should include the full name of the nominator, affiliation, and email address. When E:\FR\FM\19APN1.SGM 19APN1 16512 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices nominating a non-SPL substance, please include the rationale for the nomination. Please note that email addresses will not be posted on regulations.gov. ATSDR will evaluate data and information associated with nominated substances and will determine the final list of substances to be chosen for Toxicological Profile development. Substances will be chosen according to ATSDR’s specific guidelines for selection. These guidelines can be found in the Selection Criteria, which may be accessed at www.atsdr.cdc.gov/toxprofiles/ guidance/ATSDR_TP_ Selection%20Criteria.pdf. Pamela I. Protzel Berman, Director, Office of Policy, Partnerships and Planning, Agency for Toxic Substances and Disease Registry. [FR Doc. 2019–07916 Filed 4–18–19; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–0621] Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Bispecific Antibody Development Programs.’’ This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development. DATES: Submit either electronic or written comments on the draft guidance by June 18, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 16:23 Apr 18, 2019 Jkt 247001 • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–0621 for ‘‘Bispecific Antibody Development Programs.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Ebla Ali-Ibrahim, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301–796–3691; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16511-16512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07916]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Docket No. ATSDR-2019-0005]


Proposed Substances To Be Evaluated for Toxicological Profile 
Development

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

ACTION: Request for comments on proposed substances to be evaluated for 
Toxicological Profile development.

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

SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR) 
within the Department of Health and Human Services is initiating the 
development of another set of Toxicological Profiles. This notice 
solicits public nominations of substances for ATSDR to evaluate for 
Toxicological Profile development. ATSDR will consider nominations from 
the Substance Priority List (available at https://www.atsdr.cdc.gov/SPL/). ATSDR also accepts nominations for non-Comprehensive 
Environmental Response, Compensation, and Liability Act of 1980 (CERLA) 
substances that may have public health implications, on the basis of 
ATSDR's authority to prepare Toxicological Profiles for substances not 
found at sites on the CERCLA National Priorities List. For more 
information on the CERCLA National Priorities List, visit https://www.epa.gov/superfund/superfund-national-priorities-list-npl. The 
agency will do so in order to establish and maintain an inventory of 
literature, research, and studies on the health effects of toxic 
substances, to respond to requests for consultation, and to support the 
site-specific response actions conducted by ATSDR, as otherwise 
necessary.

DATES: Nominations from the Substance Priority List and/or additional 
substances must be received by May 20, 2019.

ADDRESSES: You may submit nominations, identified by Docket No. ATSDR-
2019-0005, by any 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, 
Mail Stop S102-1, Atlanta, GA, 30329-4027. Attn: Docket No. ATSDR-201x-
xxxx.
    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. Refer to the section Submission of Nominations (below) for the 
specific information required.

FOR FURTHER INFORMATION CONTACT: For further information, please 
contact Susan Ingber, Agency for Toxic Substances and Disease Registry, 
Division of Toxicology and Human Health Sciences, 1600 Clifton Rd. NE, 
Mail Stop S102-1, Atlanta, GA, 30329-4027, 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) with regard to hazardous substances most commonly found at 
facilities on the CERCLA National Priorities List (NPL) (for more 
information, visit https://www.epa.gov/superfund/superfund-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 known as the Substance Priority list (SPL)). This list identifies 
275 hazardous substances found at NPL sites that ATSDR and EPA have 
determined pose the most significant current potential threat to human 
health.

Substances To Be Evaluated for Toxicological Profile Development

    Each year, ATSDR develops a list of substances to be considered for 
Toxicological Profile development. The nomination process includes 
consideration of all substances on ATSDR's SPL, as well as other 
substances nominated by the public. For more information on ATSDR's 
SPL, visit https://www.atsdr.cdc.gov/SPL/.
    Submission of nominations for Toxicological Profile development: 
Today's notice invites voluntary public nominations for substances 
included on the SPL and for substances not listed on the SPL. All 
nominations should include the full name of the nominator, affiliation, 
and email address. When

[[Page 16512]]

nominating a non-SPL substance, please include the rationale for the 
nomination. Please note that email addresses will not be posted on 
regulations.gov. ATSDR will evaluate data and information associated 
with nominated substances and will determine the final list of 
substances to be chosen for Toxicological Profile development. 
Substances will be chosen according to ATSDR's specific guidelines for 
selection. These guidelines can be found in the Selection Criteria, 
which may be accessed at www.atsdr.cdc.gov/toxprofiles/guidance/ATSDR_TP_Selection%20Criteria.pdf.

Pamela I. Protzel Berman,
Director, Office of Policy, Partnerships and Planning, Agency for Toxic 
Substances and Disease Registry.
[FR Doc. 2019-07916 Filed 4-18-19; 8:45 am]
 BILLING CODE 4163-70-P