[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39769-39770]
[FR Doc No: 2018-17136]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0784]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0014

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0014,
Request for Designation and Exemption of Oceanographic Research Vessel,
without change. Our ICR describes the information we seek to collect
from the public. Before submitting this ICR to OIRA, the Coast Guard is
inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before October 9,
2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0784] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), ATTN: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION:  Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2018-0784], and
must be received by October 9, 2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include

any personal information you have provided. For more about privacy and
the docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Request for Designation and Exemption of Oceanographic
Research Vessels.
    OMB Control Number: 1625-0014.
    Summary: This collection requires submission of specific
information about a vessel in order for the vessel to be designated as
an Oceanographic Research Vessel (ORV).
    Need: Title 46 U.S.C. 2113 authorizes the Secretary of the
Department of Homeland Security to exempt Oceanographic Research
Vessels (ORV), by regulation, from provisions of Subtitle II, of Title
46, Shipping, of the United States Code, concerning maritime safety and
seaman's welfare laws. This information is necessary to ensure a vessel
qualifies for the designation of ORV under 46 CFR part 3 and 46 CFR
part 14, subpart D.
    Forms: None.
    Respondents: Owners or operators of certain vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 25
hours to 36 hours a year due to an increase in the estimated annual
number of respondents.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 31, 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2018-17136 Filed 8-9-18; 8:45 am]
 BILLING CODE 9110-04-P


This category includes agents for which, at one extreme, the degree of evidence of carcinogenicity in humans is almost sufficient, as well as those for which, at the other extreme, there are no human data but for which there is evidence of carcinogenicity in experimental animals. Agents are assigned to either Group 2A (probably carcinogenic to humans) or Group 2B (possibly carcinogenic to humans) on the basis of epidemiological and experimental evidence of carcinogenicity and mechanistic and other relevant data. The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.
    Group 2A: The agent is probably carcinogenic to human.
    This category is used when there is limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals. In some cases, an agent may be classified in this category when there is inadequate evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals and strong evidence that the carcinogenesis is mediated by a mechanism that also operates in humans. Exceptionally, an agent may be classified in this category solely on the basis of limited evidence of carcinogenicity in humans. An agent may be assigned to this category if it clearly belongs, based on mechanistic considerations, to a class of agents for which one or more members have been classified in Group 1 or Group 2A.
    Group 2B: The agent is possibly carcinogenic to humans.
    This category is used for agents for which there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals. It may also be used when there is inadequate evidence of carcinogenicity in humans but there is sufficient evidence of carcinogenicity in experimental animals. In some instances, an agent for which there is inadequate evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals together with supporting evidence from mechanistic and other relevant data may be placed in this group. An agent may be classified in this category solely on the basis of strong evidence from mechanistic and other relevant data.
Part C: National Toxicology Program (NTP), "Report on Carcinogens", Background Guidance
NTP Listing Criteria4:
    4See: http://ntp.niehs.nih.gov/go/15209.
    The criteria for listing an agent, substance, mixture, or exposure circumstance in the Report on Carcinogens (RoC) are as follows:
    Known To Be A Human Carcinogen: There is sufficient evidence of carcinogenicity from studies in humans5 that indicates a causal relationship between exposure to the agent, substance, or mixture, and human cancer.
    5This evidence can include traditional cancer epidemiology studies, data from clinical studies, and/or data derived from the study of tissues or cells from humans exposed to the substance in question that can be useful for evaluating whether a relevant cancer mechanism is operating in people.
    Reasonably Anticipated To Be A Human Carcinogen: There is limited evidence of carcinogenicity from studies in humans that indicates that a causal interpretation is credible, but that alternative explanations, such as chance, bias, or confounding factors, could not adequately be excluded,
or
there is sufficient evidence of carcinogenicity from studies in experimental animals that indicates there is an increased incidence of malignant and/or a combination of malignant and benign tumors in multiple species or at multiple tissue sites, or by multiple routes of exposure, or to an unusual degree with regard to incidence, site, or type of tumor, or age at onset,
or
there is less than sufficient evidence of carcinogenicity in humans or laboratory animals; however, the agent, substance, or mixture belongs to a well-defined, structurally-related class of substances whose members are listed in a previous Report on Carcinogens as either known to be a human carcinogen or reasonably anticipated to be a human carcinogen, or there is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans.
    Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant information. Relevant information includes, but is not limited to, dose response, route of exposure, chemical structure, metabolism, pharmacokinetics, sensitive sub-populations, genetic effects, or other data relating to mechanism of action or factors that may be unique to a given substance. For example, there may be substances for which there is evidence of carcinogenicity in laboratory animals, but there are compelling data indicating that the agent acts through mechanisms that do not operate in humans and would therefore not reasonably be anticipated to cause cancer in humans.
Part D: Table Relating Approximate Equivalences Among IARC, NTP RoC, and GHS Carcinogenicity Classifications
    The following table may be used to perform hazard classifications for carcinogenicity under the HCS (§1910.1200). It relates the approximated GHS hazard categories for carcinogenicity to the classifications provided by IARC and NTP, as described in Parts B and C of this Appendix.
    Approximate Equivalences Among Carcinogen Classification Schemes
IARC
GHS
NTP RoC
Group 1
Category 1A
Known.
Group 2A
Category 1B
Reasonably Anticipated (See Note 1).
Group 2B
Category 2
Reasonably Anticipated (See Note 1).
    Note 1:
    1. Limited evidence of carcinogenicity from studies in humans (corresponding to IARC 2A/GHS 1B);
    2. Sufficient evidence of carcinogenicity from studies in experimental animals (again, essentially corresponding to IARC 2A/GHS 1B);
    3. Less than sufficient evidence of carcinogenicity in humans or laboratory animals; however:
    a. The agent, substance, or mixture belongs to a well-defined, structurally-related class of substances whose members are listed in a previous RoC as either "Known" or "Reasonably Anticipated" to be a human carcinogen, or
    b. There is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans.
*References
  Cohen, S.M., J. Klaunig, M.E. Meek, R.N. Hill, T. Pastoor, L. Lehman-McKeeman, J. Bucher, D.G. Longfellow, J. Seed, V. Dellarco, P. Fenner-Crisp, and D. Patton. 2004. Evaluating the human relevance of chemically induced animal tumors. Toxicol. Sci. 78(2):181-186.
  Cohen, S.M., M.E. Meek, J.E. Klaunig, D.E. Patton, P.A. Fenner-Crisp. 2003. The human relevance of information on carcinogenic modes of action: Overview. Crit. Rev. Toxicol. 33(6):581-9.
  Meek, M.E., J.R. Bucher, S.M. Cohen, V. Dellarco, R.N. Hill, L. Lehman-McKeeman, D.G. Longfellow, T. Pastoor, J. Seed, D.E. Patton. 2003. A framework for human relevance analysis of information on carcinogenic modes of action. Crit. Rev. Toxicol. 33(6):591-653.
  Sonich-Mullin, C., R. Fielder, J. Wiltse, K. Baetcke, J. Dempsey, P. Fenner-Crisp, D. Grant, M. Hartley, A. Knapp, D. Kroese, I. Mangelsdorf, E. Meek, J.M. Rice, and M. Younes. 2001. The conceptual framework for evaluating a mode of action for chemical carcinogenesis. Reg. Toxicol. Pharm. 34:146-152.
  International Programme on Chemical Safety Harmonization Group. 2004. Report of the First Meeting of the Cancer Working Group. World Health Organization. Report IPCS/HSC-CWG-1/04. Geneva.
  International Agency for Research on Cancer. IARC Monographs on the Evaluation of Carcinogenic Risks to Human. Preambles to Volumes. World Health Organization. Lyon, France.
  Cohen, S.M., P.A. Fenner-Crisp, and D.E. Patton. 2003. Special Issue: Cancer Modes of Action and Human Relevance. Critical Reviews in Toxicology, R.O. McClellan, ed., Volume 33/Issue 6. CRC Press.
  Capen, C.C., E. Dybing, and J.D. Wilbourn. 1999. Species differences in thyroid, kidney and urinary bladder carcinogenesis. International Agency for Research on Cancer, Scientific Publication N° 147.
  Doi, A.M., G. Hill, J. Seely, J.R. Hailey, G. Kissling, and J.R. Buchera. 2007. α2u-Globulin nephropathy and renal tumors in National Toxicology Program studies. Toxicol. Pathol. 35:533-540.
[59 FR 6170, Feb. 9, 1994, as amended at 59 FR 17479, Apr. 13, 1994; 59 FR 65948, Dec. 22, 1994; 61 FR 9245, Mar. 7, 1996; 77 FR 17785, Mar. 26, 2012; 78 FR 9313, Feb. 8, 2013]
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