82_FR_21325 82 FR 21239 - Request for the Technical Review of 4 Draft Immediately Dangerous to Life or Health (IDLH) Value Profile Documents

82 FR 21239 - Request for the Technical Review of 4 Draft Immediately Dangerous to Life or Health (IDLH) Value Profile Documents

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 86 (May 5, 2017)

Page Range21239-21240
FR Document2017-09149

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces four (4) draft Immediately Dangerous to Life or Health (IDLH) Value Profile documents now available for public comment.

Federal Register, Volume 82 Issue 86 (Friday, May 5, 2017)
[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21239-21240]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2017-0048, NIOSH 156-C]


Request for the Technical Review of 4 Draft Immediately Dangerous 
to Life or Health (IDLH) Value Profile Documents

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 and comments.

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SUMMARY: The National Institute for Occupational Safety and Health of 
the Centers for Disease Control and Prevention announces four (4) draft 
Immediately Dangerous to Life or Health (IDLH) Value Profile documents 
now available for public comment.

Table of Contents

Dates
Addresses
For Further Information Contact
Supplementary Information
Background
Reference

DATES: Electronic or written comments must be received by June 19, 
2017.

ADDRESSES: You may submit responses, identified by CDC-2017-0048 and 
docket number NIOSH 156-C, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2017-0048; NIOSH 
156-C]. All relevant responses received will be posted without change 
to www.regulations.gov, including any personal information provided. 
For access to the docket to read background documents or information 
received, go to www.regulations.gov. All information received in 
response to this notice will also be available for public examination 
and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, 
Cincinnati, OH 45226-1998.

FOR FURTHER INFORMATION CONTACT: G. Scott Dotson, NIOSH, Education and 
Information Division, 1090 Tusculum Avenue, C-32, Cincinnati, OH 45226, 
telephone (513) 533-8540 (not a toll free number).

SUPPLEMENTARY INFORMATION: NIOSH seeks comments on four (4) draft IDLH 
values and IDLH Value Profile documents. The draft IDLH Value Profile 
documents were developed to provide the scientific rationale behind 
derivation of IDLH values for the following chemicals:

----------------------------------------------------------------------------------------------------------------
               Document #                             Chemical                               CAS
----------------------------------------------------------------------------------------------------------------
B-01....................................  Acetonitrile....................  (# 75-05-8)
B-02....................................  Chloroacetonitrile..............  (# 107-14-2)
B-03....................................  Methacrylonitrile...............  (# 126-98-7)
B-04....................................  Nitrogen dioxide................  (# 10102-44-0)
----------------------------------------------------------------------------------------------------------------

    Each IDLH Value Profile document provides a detailed summary of the 
health hazards of acute exposures to high airborne concentrations and 
the rationale for the proposed IDLH value with the chemical(s) of 
interest.
    To facilitate the review of these documents, NIOSH requests that 
the following questions be taken into consideration:

    1. Does this document clearly outline the health hazards associated 
with acute (or short-term) exposures to the chemical? If not, what 
specific information is missing from the document?
    2. Are the rationale and logic behind the derivation of an IDLH 
value for a specific chemical clearly explained? If not, what specific 
information is needed to clarify the basis of the IDLH value?
    3. Are the conclusions supported by the data?
    4. Are the tables clear and appropriate?
    5. Is the document organized appropriately? If not, what 
improvements are needed?
    6. Are you aware of any scientific data reported in governmental 
publications, databases, peer-reviewed journals, or other sources that 
should be included within this document?

    Background: In 2013, NIOSH published Current Intelligence Bulletin 
(CIB) 66--Derivation of Immediately Dangerous to Life or Health (IDLH) 
Values [NIOSH 2013]. Since the establishment of the IDLH values in the 
1970s, NIOSH has continued to review available scientific data to 
improve the protocol used to derive acute exposure guidelines, in 
addition to the chemical-specific IDLH values. The information 
presented in this CIB represents the most recent update of the 
scientific rationale and the methodology (hereby referred to as the 
IDLH methodology) used to derive IDLH values. The primary objectives of 
this document are to:

1. Provide a brief history of the development of IDLH values
2. Update the scientific bases and risk assessment methodology used to 
derive IDLH values from quality data

[[Page 21240]]

3. Provide transparency behind the rationale and derivation process for 
IDLH values
4. Demonstrate how scientifically credible IDLH values can be derived 
from available data resources

    The IDLH methodology is based on a weight-of-evidence approach that 
applies scientific judgment for critical evaluation of the quality and 
consistency of scientific data and in extrapolation from the available 
data to the IDLH value. The weight-of-evidence approach refers to 
critical examination of all available data from diverse lines of 
evidence and the derivation of a scientific interpretation on the basis 
of the collective body of data, including its relevance, quality, and 
reported results. Conceptually, the derivation process for IDLH values 
is similar to that used in other risk-assessment applications, 
including these steps:

1. Hazard characterization
2. Identification of critical adverse effects
3. Identification of a point of departure (POD)
4. Application of appropriate uncertainty factors (UFs), based on the 
study and POD
5. Determination of the final risk value

Reference

NIOSH [2013]. Current intelligence bulletin 66: derivation of 
immediately dangerous to life or health (IDLH) values. Cincinnati, 
OH: US Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Institute for Occupational Safety 
and Health, DHHS (NIOSH) Publication 2014-100.

John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2017-09149 Filed 5-4-17; 8:45 am]
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                                                                                              Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices                                                                                          21239

                                                Campus through the front entrance on                                      DEPARTMENT OF HEALTH AND                                                    docket number NIOSH 156–C, by any of
                                                Clifton Road. Vehicles may be searched,                                   HUMAN SERVICES                                                              the following methods:
                                                and the guard force will then direct                                                                                                                     • Federal eRulemaking Portal: http://
                                                visitors to the designated parking area.                                  Centers for Disease Control and                                             www.regulations.gov. Follow the
                                                Upon arrival at the facility, visitors must                               Prevention                                                                  instructions for submitting comments.
                                                present government-issued photo                                           [Docket Number CDC–2017–0048, NIOSH                                            • Mail: National Institute for
                                                identification (e.g., a valid federal                                     156–C]                                                                      Occupational Safety and Health, NIOSH
                                                identification badge, state driver’s                                                                                                                  Docket Office, 1090 Tusculum Avenue,
                                                license, state non-driver’s identification                                Request for the Technical Review of 4                                       MS C–34, Cincinnati, Ohio 45226–1998.
                                                card, or passport). Non-United States                                     Draft Immediately Dangerous to Life or                                         Instructions: All information received
                                                citizens must complete the required                                       Health (IDLH) Value Profile Documents                                       in response to this notice must include
                                                security paperwork prior to the meeting                                                                                                               the agency name and docket number
                                                                                                                          AGENCY:  National Institute for
                                                date and must present a valid passport,                                                                                                               [CDC–2017–0048; NIOSH 156–C]. All
                                                                                                                          Occupational Safety and Health
                                                                                                                                                                                                      relevant responses received will be
                                                visa, Permanent Resident Card, or other                                   (NIOSH) of the Centers for Disease
                                                                                                                                                                                                      posted without change to
                                                type of work authorization document                                       Control and Prevention (CDC),
                                                                                                                                                                                                      www.regulations.gov, including any
                                                upon arrival at the facility. All persons                                 Department of Health and Human
                                                                                                                                                                                                      personal information provided. For
                                                entering the building must pass through                                   Services (HHS).
                                                                                                                                                                                                      access to the docket to read background
                                                a metal detector. CDC Security                                            ACTION: Request for information and                                         documents or information received, go
                                                personnel will issue a visitor’s ID badge                                 comments.                                                                   to www.regulations.gov. All information
                                                at the entrance to Building 19. Visitors                                                                                                              received in response to this notice will
                                                may receive an escort to the meeting                                      SUMMARY:   The National Institute for
                                                                                                                          Occupational Safety and Health of the                                       also be available for public examination
                                                room. All items brought to HHS/CDC                                                                                                                    and copying at the NIOSH Docket
                                                are subject to inspection.                                                Centers for Disease Control and
                                                                                                                          Prevention announces four (4) draft                                         Office, 1150 Tusculum Avenue, Room
                                                  Dated: May 2, 2017.                                                     Immediately Dangerous to Life or Health                                     155, Cincinnati, OH 45226–1998.
                                                Sandra Cashman,                                                           (IDLH) Value Profile documents now                                          FOR FURTHER INFORMATION CONTACT: G.
                                                Executive Secretary, Centers for Disease                                  available for public comment.                                               Scott Dotson, NIOSH, Education and
                                                Control and Prevention.                                                                                                                               Information Division, 1090 Tusculum
                                                                                                                          Table of Contents                                                           Avenue, C–32, Cincinnati, OH 45226,
                                                [FR Doc. 2017–09133 Filed 5–4–17; 8:45 am]
                                                                                                                          Dates                                                                       telephone (513) 533–8540 (not a toll free
                                                BILLING CODE 4163–18–P
                                                                                                                          Addresses                                                                   number).
                                                                                                                          For Further Information Contact                                             SUPPLEMENTARY INFORMATION: NIOSH
                                                                                                                          Supplementary Information                                                   seeks comments on four (4) draft IDLH
                                                                                                                          Background                                                                  values and IDLH Value Profile
                                                                                                                          Reference                                                                   documents. The draft IDLH Value
                                                                                                                          DATES: Electronic or written comments                                       Profile documents were developed to
                                                                                                                          must be received by June 19, 2017.                                          provide the scientific rationale behind
                                                                                                                          ADDRESSES: You may submit responses,                                        derivation of IDLH values for the
                                                                                                                          identified by CDC–2017–0048 and                                             following chemicals:

                                                                   Document #                                                                                         Chemical                                                                        CAS

                                                B–01   .......................................................   Acetonitrile ............................................................................................................   (#   75–05–8)
                                                B–02   .......................................................   Chloroacetonitrile ..................................................................................................       (#   107–14–2)
                                                B–03   .......................................................   Methacrylonitrile ....................................................................................................      (#   126–98–7)
                                                B–04   .......................................................   Nitrogen dioxide ....................................................................................................       (#   10102–44–0)



                                                  Each IDLH Value Profile document                                        not, what specific information is needed                                    1970s, NIOSH has continued to review
                                                provides a detailed summary of the                                        to clarify the basis of the IDLH value?                                     available scientific data to improve the
                                                health hazards of acute exposures to                                        3. Are the conclusions supported by                                       protocol used to derive acute exposure
                                                high airborne concentrations and the                                      the data?                                                                   guidelines, in addition to the chemical-
                                                rationale for the proposed IDLH value                                       4. Are the tables clear and                                               specific IDLH values. The information
                                                with the chemical(s) of interest.                                         appropriate?                                                                presented in this CIB represents the
                                                  To facilitate the review of these                                         5. Is the document organized                                              most recent update of the scientific
                                                documents, NIOSH requests that the                                        appropriately? If not, what                                                 rationale and the methodology (hereby
                                                following questions be taken into                                         improvements are needed?                                                    referred to as the IDLH methodology)
                                                consideration:                                                              6. Are you aware of any scientific data                                   used to derive IDLH values. The
                                                                                                                          reported in governmental publications,
                                                                                                                                                                                                      primary objectives of this document are
                                                  1. Does this document clearly outline                                   databases, peer-reviewed journals, or
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                                                the health hazards associated with acute                                                                                                              to:
                                                                                                                          other sources that should be included
                                                (or short-term) exposures to the                                          within this document?                                                       1. Provide a brief history of the
                                                chemical? If not, what specific                                             Background: In 2013, NIOSH                                                     development of IDLH values
                                                information is missing from the                                           published Current Intelligence Bulletin                                     2. Update the scientific bases and risk
                                                document?                                                                 (CIB) 66—Derivation of Immediately                                               assessment methodology used to
                                                  2. Are the rationale and logic behind                                   Dangerous to Life or Health (IDLH)                                               derive IDLH values from quality
                                                the derivation of an IDLH value for a                                     Values [NIOSH 2013]. Since the                                                   data
                                                specific chemical clearly explained? If                                   establishment of the IDLH values in the


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                                                21240                             Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices

                                                3. Provide transparency behind the                      an opportunity for the public to                      FOR FURTHER INFORMATION CONTACT:
                                                     rationale and derivation process for               comment on CMS’ intention to collect                  Reports Clearance Office at (410) 786–
                                                     IDLH values                                        information from the public. Under the                1326.
                                                4. Demonstrate how scientifically                       Paperwork Reduction Act of 1995 (the                  SUPPLEMENTARY INFORMATION:
                                                     credible IDLH values can be derived                PRA), federal agencies are required to
                                                     from available data resources                      publish notice in the Federal Register                Contents
                                                   The IDLH methodology is based on a                   concerning each proposed collection of                  This notice sets out a summary of the
                                                weight-of-evidence approach that                        information (including each proposed                  use and burden associated with the
                                                applies scientific judgment for critical                extension or reinstatement of an existing             following information collections. More
                                                evaluation of the quality and                           collection of information) and to allow               detailed information can be found in
                                                consistency of scientific data and in                   60 days for public comment on the                     each collection’s supporting statement
                                                extrapolation from the available data to                proposed action. Interested persons are               and associated materials (see
                                                the IDLH value. The weight-of-evidence                  invited to send comments regarding our                ADDRESSES).
                                                approach refers to critical examination                 burden estimates or any other aspect of               CMS–10320 Health Care Reform
                                                of all available data from diverse lines                this collection of information, including               Insurance Web Portal Requirements
                                                of evidence and the derivation of a                     the necessity and utility of the proposed               45 CFR part 159
                                                scientific interpretation on the basis of               information collection for the proper                 CMS–724 Medicare/Medicaid
                                                the collective body of data, including its              performance of the agency’s functions,                  Psychiatric Hospital Survey Data and
                                                relevance, quality, and reported results.               the accuracy of the estimated burden,                   Supporting Regulations
                                                Conceptually, the derivation process for                ways to enhance the quality, utility, and               Under the PRA (44 U.S.C. 3501–
                                                IDLH values is similar to that used in                  clarity of the information to be                      3520), federal agencies must obtain
                                                other risk-assessment applications,                     collected, and the use of automated                   approval from the Office of Management
                                                including these steps:                                  collection techniques or other forms of               and Budget (OMB) for each collection of
                                                1. Hazard characterization                              information technology to minimize the                information they conduct or sponsor.
                                                2. Identification of critical adverse                   information collection burden.                        The term ‘‘collection of information’’ is
                                                     effects                                            DATES:  Comments must be received by                  defined in 44 U.S.C. 3502(3) and 5 CFR
                                                3. Identification of a point of departure               July 5, 2017.                                         1320.3(c) and includes agency requests
                                                     (POD)                                                                                                    or requirements that members of the
                                                4. Application of appropriate                           ADDRESSES:   When commenting, please
                                                                                                                                                              public submit reports, keep records, or
                                                     uncertainty factors (UFs), based on                reference the document identifier or
                                                                                                                                                              provide information to a third party.
                                                     the study and POD                                  OMB control number. To be assured
                                                                                                                                                              Section 3506(c)(2)(A) of the PRA
                                                5. Determination of the final risk value                consideration, comments and
                                                                                                                                                              requires federal agencies to publish a
                                                                                                        recommendations must be submitted in
                                                Reference                                                                                                     60-day notice in the Federal Register
                                                                                                        any one of the following ways:
                                                                                                                                                              concerning each proposed collection of
                                                NIOSH [2013]. Current intelligence bulletin               1. Electronically. You may send your                information, including each proposed
                                                   66: derivation of immediately dangerous              comments electronically to http://                    extension or reinstatement of an existing
                                                   to life or health (IDLH) values.                     www.regulations.gov. Follow the                       collection of information, before
                                                   Cincinnati, OH: US Department of                     instructions for ‘‘Comment or
                                                   Health and Human Services, Centers for                                                                     submitting the collection to OMB for
                                                                                                        Submission’’ or ‘‘More Search Options’’               approval. To comply with this
                                                   Disease Control and Prevention, National
                                                                                                        to find the information collection                    requirement, CMS is publishing this
                                                   Institute for Occupational Safety and
                                                   Health, DHHS (NIOSH) Publication                     document(s) that are accepting                        notice.
                                                   2014–100.                                            comments.
                                                                                                          2. By regular mail. You may mail                    Information Collection
                                                John Howard,                                                                                                    1. Type of Information Collection
                                                                                                        written comments to the following
                                                Director, National Institute for Occupational           address: CMS, Office of Strategic                     Request: Extension of a currently
                                                Safety and Health, Centers for Disease Control                                                                approved information collection; Title
                                                and Prevention.
                                                                                                        Operations and Regulatory Affairs,
                                                                                                        Division of Regulations Development,                  of Information Collection: Health Care
                                                [FR Doc. 2017–09149 Filed 5–4–17; 8:45 am]
                                                                                                        Attention: Document Identifier/OMB                    Reform Insurance Web Portal
                                                BILLING CODE 4163–19–P
                                                                                                        Control Number llll, Room C4–26–                      Requirements 45 CFR part 159; Use: In
                                                                                                        05, 7500 Security Boulevard, Baltimore,               accordance with the provisions of the
                                                                                                        Maryland 21244–1850.                                  ACA referenced above, the U.S.
                                                DEPARTMENT OF HEALTH AND
                                                                                                          To obtain copies of a supporting                    Department of Health and Human
                                                HUMAN SERVICES
                                                                                                        statement and any related forms for the               Services created a Web site called
                                                Centers for Medicare & Medicaid                         proposed collection(s) summarized in                  healthcare.gov to meet these and other
                                                Services                                                this notice, you may make your request                provisions of the law, and data
                                                                                                        using one of following:                               collection was conducted for six months
                                                [Document Identifier: CMS–10320 and CMS–                                                                      based upon an emergency information
                                                724]                                                      1. Access CMS’ Web site address at
                                                                                                                                                              collection request. The interim final rule
                                                                                                        https://www.cms.gov/Regulations-and-
                                                                                                                                                              published on May 5, 2010 served as the
                                                Agency Information Collection                           Guidance/Legislation/
                                                                                                                                                              emergency Federal Register notice for
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                                                Activities: Proposed Collection;                        PaperworkReductionActof1995/PRA-
                                                                                                                                                              the prior information collection request.
                                                Comment Request                                         Listing.html.
                                                                                                                                                              The Office of Management and Budget
                                                AGENCY: Centers for Medicare &                            2. Email your request, including your               (OMB) reviewed the request under
                                                Medicaid Services, HHS.                                 address, phone number, OMB number,                    emergency processing and approved it
                                                                                                        and CMS document identifier, to                       on April 30, 2010.
                                                ACTION: Notice.
                                                                                                        Paperwork@cms.hhs.gov.                                  CMS updated the web portal system
                                                SUMMARY: The Centers for Medicare &                       3. Call the Reports Clearance Office at             where state Departments of Insurance
                                                Medicaid Services (CMS) is announcing                   (410) 786–1326.                                       and issuers log in using a custom user


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Document Created: 2018-11-08 08:39:29
Document Modified: 2018-11-08 08:39:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for information and comments.
DatesElectronic or written comments must be received by June 19, 2017.
ContactG. Scott Dotson, NIOSH, Education and Information Division, 1090 Tusculum Avenue, C-32, Cincinnati, OH 45226, telephone (513) 533-8540 (not a toll free number).
FR Citation82 FR 21239 

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