Request for Information on Toxicological and Physicochemical Data of Engineered Nanomaterials To Evaluate in Developing Categorical Occupational Exposure Limits (OELs), 68935-68936 [2019-27169]

Download as PDF Federal Register / Vol. 84, No. 242 / Tuesday, December 17, 2019 / Notices and Conservation, William R. Snodgrass—Tennessee Tower, 11th Floor, 312 Rosa L. Parks Avenue, Nashville, Tennessee 37243; and the Drinking Water Section, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303. FOR FURTHER INFORMATION CONTACT: Dale Froneberger, EPA Region 4, Drinking Water Section, by mail at the Atlanta street address given above, by telephone at (404) 562–9446, or by email at froneberger.dale@epa.gov. SUPPLEMENTARY INFORMATION: The State of Tennessee has submitted a request that EPA approve a revision to the State’s Safe Drinking Water Act Public Water System Supervision Program to include the authority to implement and enforce the Revised Total Coliform Rule. For the request to be approved, EPA must find the state regulations codified at Tenn. Comp. R. & Regs. 0400–45–01 to be no less stringent than the federal rule codified at 40 CFR part 141. EPA reviewed Tennessee’s application using the federal statutory provisions (Section 1413 of the Safe Drinking Water Act), federal regulations (at 40 CFR parts 141 and 142), state regulations, state policies and procedures for implementing the rule, regulatory crosswalk, and EPA regulatory guidance to determine whether the request for revision is approvable. EPA determined that the Tennessee regulations are no less stringent than the corresponding federal rule and the revision otherwise meets applicable Safe Drinking Water Act requirements. Therefore, EPA intends to approve this revision. If EPA does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing on her own motion, this approval shall become final and effective on January 16, 2020. of the FDIC Building located at 550 17th Street NW, Washington, DC. STATUS: Closed. MATTERS TO BE CONSIDERED: In calling the meeting, the Board determined, on motion of Director Joseph M. Otting (Comptroller of the Currency), seconded by Director Martin J. Gruenberg, and concurred in by Director Kathleen L. Kraninger (Director, Consumer Financial Protection Bureau), and Chairman Jelena McWilliams, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days’ notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B) of the ‘‘Government in the Sunshine Act’’ (5 U.S.C. 552b(c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B). CONTACT PERSON FOR MORE INFORMATION: Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Executive Secretary of the Corporation, at 202– 898–7043. Authority: Section 1413 of the Safe Drinking Water Act, as amended (1996), and 40 CFR part 142. [CDC–2019–0111, NIOSH–332] Dated: December 2, 2019. Mary S. Walker, Regional Administrator, Region 4. [FR Doc. 2019–27156 Filed 12–16–19; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 6714–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Request for Information on Toxicological and Physicochemical Data of Engineered Nanomaterials To Evaluate in Developing Categorical Occupational Exposure Limits (OELs) National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for information. FEDERAL DEPOSIT INSURANCE CORPORATION Sunshine Act Meeting 3:49 p.m. on Thursday, December 12, 2019. PLACE: The meeting was held in the Board Room located on the sixth floor TIME AND DATE: 18:15 Dec 16, 2019 [FR Doc. 2019–27218 Filed 12–13–19; 11:15 am] AGENCY: BILLING CODE 6560–50–P VerDate Sep<11>2014 Dated at Washington, DC, on, December 12, 2019. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. Jkt 250001 The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 68935 evaluate the scientific data on engineered nanomaterials (ENMs) to develop categorical occupational exposure limits (OELs) based on the available scientific evidence regarding the hazard or safety of these materials. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible adverse health risks of occupational exposure to ENMs. DATES: Electronic or written comments must be received by February 18, 2020. ADDRESSES: You may submit comments, identified by CDC–2019–0111 and Docket Number NIOSH–332, by either of the two following methods: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 1090 Tusculum Avenue, Cincinnati, OH 45226. Instructions: All information received in response to this notice must include the agency name and docket number [CDC–2019–0111; NIOSH–332]. All relevant comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. All electronic comments should be formatted in Microsoft Word. Please make reference to CDC–2019–0111 and Docket Number NIOSH–332. FOR FURTHER INFORMATION CONTACT: Nathan M. Drew, MS, NIOSH, MS–C14, 1090 Tusculum Avenue, Cincinnati, OH 45226, telephone (513) 533–8352. SUPPLEMENTARY INFORMATION: In 2017, NIOSH contributed to the International Organization for Standardization (ISO) technical report on frameworks for developing OELs for nano-objects [ISO 2016]. In 2019, NIOSH published a Technical Report on occupational exposure banding guidance [NIOSH 2019]. The information presented in these Technical Reports represents the most recent update of the scientific rationale and methodology for establishing hazard values for chemicals, which includes ENMs. The development of an OEL for an individual chemical involves a critical review of the available scientific data in humans and animals to identify relevant studies and to characterize the various lines of evidence that can support the derivation of the OEL. NIOSH requests information for ENMs to include human, animal, and cellular toxicology data, including but not limited to: Acute, subchronic, or chronic data; the physicochemical characterization of those ENMs; and other information about the biological mechanisms and E:\FR\FM\17DEN1.SGM 17DEN1 68936 Federal Register / Vol. 84, No. 242 / Tuesday, December 17, 2019 / Notices toxicological effects of ENMs. NIOSH is also seeking information on studies that include evaluating the dose-response relationships between exposure to ENMs and the development of adverse lung effects including inflammation, fibrosis, or neoplasia. Supporting information for published studies should include a full citation. For unpublished studies please include authors, affiliations, year, and any context on how the data were collected. NIOSH will publish a Technical Report which describes the data, methods, and findings for the development of categorical OELs for ENMs, which may include relevant information submitted in response to this request. The draft Technical Report will be made available for public comment in a subsequent notice. References [ISO 2016] Nanotechnologies—Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs). International Organization for Standardization (ISO) Technical Report. ISO/TR 18637, published November 21. ISO, Geneva, Switzerland. [NIOSH 2019] Technical report: The NIOSH occupational exposure banding process for chemical risk management. By Lentz TJ, Seaton M, Rane P, Gilbert SJ, McKernan LT, Whittaker C. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2019–132 John J. Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2019–27169 Filed 12–16–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10638, CMS– R–5, CMS–287–19, and CMS–10088] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. jbell on DSKJLSW7X2PROD with NOTICES AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect SUMMARY: VerDate Sep<11>2014 18:15 Dec 16, 2019 Jkt 250001 information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by January 16, 2020. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806 OR Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ website address at website address at https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. 1. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 2. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision with change of a currently approved collection; Title of Information Collection: Application for New Medical Services and Technologies Seeking to Qualify for Add-On Payments Under the Hospital Inpatient Prospective Payment System; Use: Section 1886(d)(5)(K) authorizes the Secretary to establish a special payment methodology for new medical services and technologies used in inpatient procedures. To qualify for additional payments under this provision; a new technology must represent a substantial clinical improvement; data reflecting the cost of new technology must not yet be available in the data used to recalibrate the Medicare severity diagnosis-related groups (MS–DRGs); and the MS–DRG payment rate otherwise applicable to the new technology would be inadequate (see 42 CFR 412.87(b)). we are revising the estimated annual number of respondents from 32 to 62, based on the proposed alternative new technology add-on payment pathway for certain devices included in the FY 2020 IPPS proposed rule (CMS–1716–P). The existing regulations at 42 CFR 412.87 implement these provisions and specify three criteria for a new medical service or technology to receive the additional payment: (1) The medical service or technology must be new; (2) the medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the service or technology must demonstrate a substantial clinical improvement over existing services or technologies. In the FY 2020 IPPS proposed rule (84 FR 19371—19373), we proposed an alternative new technology add-on payment pathway for certain devices. Specifically, for applications received for new technology add-on payments for FY 2021 and subsequent fiscal years, we proposed that a medical device that has received Federal Drug Administration (FDA) marketing authorization (that is, E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Notices]
[Pages 68935-68936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2019-0111, NIOSH-332]


Request for Information on Toxicological and Physicochemical Data 
of Engineered Nanomaterials To Evaluate in Developing Categorical 
Occupational Exposure Limits (OELs)

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for information.

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

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) intends 
to evaluate the scientific data on engineered nanomaterials (ENMs) to 
develop categorical occupational exposure limits (OELs) based on the 
available scientific evidence regarding the hazard or safety of these 
materials.
    NIOSH seeks to obtain materials, including published and 
unpublished reports and research findings, to evaluate the possible 
adverse health risks of occupational exposure to ENMs.

DATES: Electronic or written comments must be received by February 18, 
2020.

ADDRESSES: You may submit comments, identified by CDC-2019-0111 and 
Docket Number NIOSH-332, by either of the two following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2019-0111; NIOSH-
332]. All relevant comments received will be posted without change to 
https://www.regulations.gov, including any personal information 
provided. All electronic comments should be formatted in Microsoft 
Word. Please make reference to CDC-2019-0111 and Docket Number NIOSH-
332.

FOR FURTHER INFORMATION CONTACT: Nathan M. Drew, MS, NIOSH, MS-C14, 
1090 Tusculum Avenue, Cincinnati, OH 45226, telephone (513) 533-8352.

SUPPLEMENTARY INFORMATION: In 2017, NIOSH contributed to the 
International Organization for Standardization (ISO) technical report 
on frameworks for developing OELs for nano-objects [ISO 2016]. In 2019, 
NIOSH published a Technical Report on occupational exposure banding 
guidance [NIOSH 2019]. The information presented in these Technical 
Reports represents the most recent update of the scientific rationale 
and methodology for establishing hazard values for chemicals, which 
includes ENMs.
    The development of an OEL for an individual chemical involves a 
critical review of the available scientific data in humans and animals 
to identify relevant studies and to characterize the various lines of 
evidence that can support the derivation of the OEL. NIOSH requests 
information for ENMs to include human, animal, and cellular toxicology 
data, including but not limited to: Acute, subchronic, or chronic data; 
the physicochemical characterization of those ENMs; and other 
information about the biological mechanisms and

[[Page 68936]]

toxicological effects of ENMs. NIOSH is also seeking information on 
studies that include evaluating the dose-response relationships between 
exposure to ENMs and the development of adverse lung effects including 
inflammation, fibrosis, or neoplasia. Supporting information for 
published studies should include a full citation. For unpublished 
studies please include authors, affiliations, year, and any context on 
how the data were collected.
    NIOSH will publish a Technical Report which describes the data, 
methods, and findings for the development of categorical OELs for ENMs, 
which may include relevant information submitted in response to this 
request. The draft Technical Report will be made available for public 
comment in a subsequent notice.

References

[ISO 2016] Nanotechnologies--Overview of available frameworks for 
the development of occupational exposure limits and bands for nano-
objects and their aggregates and agglomerates (NOAAs). International 
Organization for Standardization (ISO) Technical Report. ISO/TR 
18637, published November 21. ISO, Geneva, Switzerland.
[NIOSH 2019] Technical report: The NIOSH occupational exposure 
banding process for chemical risk management. By Lentz TJ, Seaton M, 
Rane P, Gilbert SJ, McKernan LT, Whittaker C. Cincinnati, OH: U.S. 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, National Institute for Occupational Safety and 
Health, DHHS (NIOSH) Publication No. 2019-132

John J. Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2019-27169 Filed 12-16-19; 8:45 am]
 BILLING CODE 4163-18-P

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