[Federal Register: January 13, 2009 (Volume 74, Number 8)]
[Notices]
[Page 1695-1697]
[DOCID:fr13ja09-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0674]

Participation of Certain Population Subsets in Clinical Drug
Trials; Request for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is seeking information
and comments on issues related to the enrollment of certain populations
in clinical drug trials. Particularly, we are requesting information
and comments from medical product manufacturers, institutional review
boards (IRBs), patient groups, universities, researchers, community
groups, and other interested parties. This request is related to FDA's
implementation of the Food and Drug Administration Amendments Act of
2007 (FDAAA) section 901, which requires recommendations be included in
a report to Congress addressing best practice approaches on increasing
the participation of elderly populations, children, racially and
ethnically diverse communities, and medically underserved populations
in clinical drug trials. FDA requests that those with information on
possible approaches to increase participation of these groups in
clinical drug trials submit comments.

DATES: Submit written or electronic comments by February 27, 2009.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brenda Evelyn, Office of Special
Health Issues, Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 901 of FDAAA requires that FDA submit a report to Congress
that includes ``recommendations regarding impediments to the
participation of elderly populations, children, racially and ethnically
diverse communities and medically underserved populations in clinical
drug trials'' and recommendations that address ``best practice
approaches for increasing the inclusion of such subsets of the general
population'' in clinical drug trials (FDAAA, section 901(d)(5)). In
developing this report, FDA seeks comments that may help to develop
these recommendations.
    Participation of all segments of the population in medical research
is critical to public health. The ability to develop drugs that are
safe and effective for diverse groups hinges on the availability of
clinical drug trial participants from these same groups. Some
researchers and public health experts argue that inconsistent
representation of certain communities can potentially lead to health
disparities and insufficient data for risk assessment. FDA has
previously identified the need for inclusion of children, both sexes,
the elderly, racially and ethnically diverse communities, and other
populations in clinical trials so that data are available to evaluate
the potential differences among these subgroups (63 FR 6854, February
11, 1998). According to the Department of Health and Human Services
(HHS) Office of Minority Health, in a recent prostate cancer study,
only 8 percent of the 18,000 participants were minorities
(www.omhrc.gov/templates/content.aspx?ID=5147). Increased participation
from all of these sub-groups may help assure that data relevant to the
entire treatment population are obtained.
    In addition, statutory mandates and incentives such as the
Pediatric Research Equity Act (PREA) (Public Law No. 108-155 as amended
by FDAAA) and the Best Pharmaceuticals for Children Act (BPCA) (Public
Law No. 107-109 as amended by FDAAA) require and encourage medical
research to consider implications for pediatric populations.
    For over 20 years, FDA has worked to encourage broad participation
of all groups in clinical drug trials. Under FDA regulations (21 CFR
312.33), all investigational new drug (IND) applications must include
in annual reports the number of patients tabulated by age, gender, and
race, and under 21 CFR 314.50(d)(5)(v) and (d)(5)(vi), new drug
applications (NDA) are required to include analyses of efficacy and
safety by demographic subgroups. Biologics license applications
typically include analyses of efficacy and safety by demographic
subgroups. The International Conference on Harmonization (ICH) guidance
on the common technical document also calls for such analyses (see M4E:
The CTD--Efficacy (August 2001) available at http://www.fda.gov/cber/
gdlns/m4ectd.pdf.).
    FDA has issued labeling recommendations for specific sub-
populations (Guidance for Industry: Content and Format of the Adverse
Reactions Section of Labeling for Human Prescription Drugs and
Biological Products, January 2006, available at http://www.fda.gov/
cber/gdlns/cfadvers.htm) and guidelines for studying gender differences
in clinical drug studies (Guideline for the Study and Evaluation of
Gender, July 1993, available at http://www.fda.gov/cder/Guidance/
old036fn.pdf). FDA has made recommendations for minimum standards for
the collection and use of race and ethnicity information to assist in
the reporting of the summary of safety and effectiveness data by
demographic subgroups (age, gender, race), as well as an analysis of
whether modifications of dose or dosage intervals are needed for
specific subgroups. (Guidance for Industry: Collection of Race and
Ethnicity Data in Clinical Trials, September 2005, available at http://
www.fda.gov/CBER/gdlns/racethclin.htm; see, also ICH E-7 Guideline for
Industry, Studies in Support of Special Populations: Geriatrics (August
1994) available at

http://www.fda.gov/cder/guidance/iche7.pdf and Reviewer Guidance:
Conducting a Clinical Safety Review of a New Product Application and
Preparing a Report on the Review (February 2005) available at http://
www.fda.gov/cder/guidance/3580fnl.pdf.)
    Other agencies have also issued guidelines for the participation of
diverse groups in clinical trials. For example, the National Institutes
of Health (NIH) requires the inclusion of women and minority groups in
NIH-funded trials unless an exception is warranted (NIH Policy on the
Inclusion of Women and Minorities as Subjects in Clinical Research as
amended October 2001, information is available at http://
grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm). NIH also has issued guidelines for inclusion of children as
research subjects (March 1998 NIH Policy and Guidelines on the
Inclusion of Children as Participants in Research Involving Human
Subjects, available at http://grants.nih.gov/grants/guide/notice-files/
not98-024.html).
    Currently, healthcare professional organizations, various
universities, foundations, and industries are taking steps to encourage
broad participation of all populations in clinical drug trials.
    Since 1998, the National Medical Association has administered
Project IMPACT, a program initially funded by HHS designed to train
African American physicians on being clinical investigators and to
increase knowledge and raise awareness about clinical trials among
African American physicians and consumers. (Information is available at
http://www.omhrc.gov/assets/pdf/checked/Project%20IMPACT_
Increasing%20Minority%20Participation%20and%20Awareness%20of%20Clinical%
20Trials.pdf.) The program is currently being funded by AstraZeneca and
has expanded to include the Interamerican College of Physicians and
Surgeons, an Hispanic health professional organization. (Information is
available at http://www.astrazeneca-us.com/community-support/
?itemId=1338629.) Further, some foundations have supported studies and
programs designed to increase participation (e.g., the Lance Armstrong
Foundation's support of the Education Network to Advance Clinical
Cancer Trials, intended ``to foster awareness about cancer clinical
trials, enhance their acceptability and improve access to them.''
Information is available at http://www.livestrong.org/site/
c.khLXK1PxHmF/b.2662065/k.C0D9/ENACCT.htm). Industry has partnered with
academia to fund similar programs (e.g., Genentech's and Baylor College
of Medicine's research initiative with the Intercultural Cancer
Council, ``Project addresses underrepresentation of minorities,
underserved patients in clinical studies.'' Information is available at
http://www.bcm.edu/news/item.cfm?newsID=420).
    We are seeking information to determine if additional approaches
are necessary to increase participation of certain subsets of the
general population (elderly populations, children, racially and
ethnically diverse communities, and medically underserved populations)
in drug clinical trials.

II. Request for Comments and Information

    In providing comments, we are particularly interested in responses
to the following questions regarding the participation of certain
population subsets in clinical drug trials.

A. Communication and Knowledge Barriers

    1. To what extent do differences in native language, educational
level, and literacy interfere with members of some populations'
participation in clinical trials:
     Finding out about the existence of trials and how to
enroll
     Understanding informed consent documents and procedures
     Adhering to clinical trial instructions and drug regimens
     Completing clinical trials
    2. To what extent do limitations in access to technology and to
medical care in general decrease the chance that members of some
populations will know about the existence of clinical trials and how to
participate in them?
     Are these subsets of populations aware of
www.ClinicalTrials.gov?
    3. What proven methods, i.e., best practices, are available to
address the impact of these potential barriers to communication about
the existence of, and how to participate in, clinical drug trials?
    4. To what extent are health care providers aware of
www.ClinicalTrials.gov?

B. Trust and Cultural Sensitivity

    1. To what extent do culturally-bound beliefs or traditions, or
trust or stereotypes about the medical research community, interfere
with group members' willingness to participate in clinical drug trials?
     Are particular populations significantly more or less
trusting of those who conduct medical research?
    2. What approaches to address cultural sensitivity and trust
issues, including increased collaboration with community-based
organizations, have been shown to increase successful clinical trial
participation?
    3. To what extent do the beliefs of clinical trial personnel about
the commitment or ability of members of some populations to follow
through with a protocol influence willingness to recruit and enroll
such individuals in clinical drug trials?
    4. What approaches, i.e. best practices, have been shown to improve
trust between potential participants and clinical drug trial
researchers and healthcare providers who can provide referrals?

C. Costs of Clinical Trial Participation

    Note: The term ``cost'' may vary from participant to participant
and is intended to include time lost (i.e. wages, childcare, etc),
effort expended, and other sacrifices that may be necessary to
participate in clinical drug trials.
    1. To what extent do data show that the ``costs'' of participation,
to either potential participants or to those who conduct clinical drug
trials, prohibit participation or enrollment of particular populations?
    2. To what extent do data address the following?
     Do particular populations understand the potential public
benefit from participating in clinical drug trials as compared to the
``cost'' to the participant?
     Is the belief that there is a public benefit from
participating in clinical drug trials a sufficient incentive for
participation for some populations?
    3. To what extent do data show that limited health insurance
coverage is an impediment to clinical drug trial participation?
    4. To what degree is the geographical accessibility to clinical
trials a significant cost that affects the participation of some
populations?
    5. What are the ``costs'' of participating in clinical drug trials
that are most relevant to some populations? How might these be reduced?
    6. What approaches, i.e. best practices, have been shown to
decrease ``costs'' with resulting increased participation in clinical
drug trials?

D. Other

    1. Please describe any other barriers, or best practice approaches,
that HHS should consider in striving to increase participation of
certain population subsets in clinical drug trials.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: January 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-450 Filed 1-12-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 80 (Thursday, April 27, 2017)]
[Rules and Regulations]
[Pages 19325-19328]
[FR Doc No: 2017-08530]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 190

[Docket No. PHMSA-2016-0010; Amdt. No. 190-17]
RIN-2137-AF16

Pipeline Safety: Inflation Adjustment of Maximum Civil Penalties

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration
(PHMSA) is revising references in its regulations to the maximum civil
penalties for violations of Federal pipeline safety laws, or any PHMSA
regulations or orders issued thereunder. Under the Federal Civil
Penalties Inflation Adjustment Act Improvements Act of 2015, which
further amended the Federal Civil Penalties Inflation Adjustment Act of
1990, Federal agencies are required to adjust their civil monetary
penalties effective January 15, 2017, and annually thereafter, to
account for changes in inflation.
    PHMSA finds good cause to amend the regulations related to civil
penalties without notice or opportunity for public comment. Advance
public notice is

unnecessary for the reasons described in the SUPPLEMENTARY INFORMATION
section.

DATES: The effective date of this final rule is April 27, 2017.

FOR FURTHER INFORMATION CONTACT: Ahuva Battams, Attorney-Advisor,
Pipeline Safety Division, Office of Chief Counsel, the Pipeline and
Hazardous Materials Safety Administration, by telephone at<PHONE_NUMBER>
or email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Civil Penalty Amendments
II. Justification for the Final Rule
III. Rulemaking Analyses and Notices
    A. Statutory/Legal Authority for This Rulemaking
    B. Executive Order 12866, Executive Order 13563, and Department
of Transportation (DOT) Regulatory Policies and Procedures
    C. Executive Order 13132
    D. Executive Order 13175
    E. Executive Order 13211
    F. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies
    G. Paperwork Reduction Act
    H. Unfunded Mandates Reform Act of 1995
    I. Environmental Assessment
    J. Executive Order 13609 and International Trade Analysis
    K. Privacy Act
    L. Regulation Identifier Number (RIN)
    M. Executive Order 13609 and International Trade Analysis

I. Civil Penalty Amendments

    On June 30, 2016, PHMSA published an interim final rule, (81 FR
42564) in the Federal Register. Under the Pipeline Safety, Regulatory
Certainty, and Job Creation Act of 2015 (the 2015 Act), Public Law 114-
74, and consistent with the process outlined in the Office of
Management and Budget's (OMB) Memorandum for the Heads of Executive
Departments and Agencies: ``Implementation of the Federal Civil
Penalties Inflation Adjustment Act Improvements Act of 2015,'' M-16-06
(OMB Memorandum M-16-06), the interim final rule stated that PHMSA is
revising references in its regulations to the maximum civil penalties
for violations of Federal pipeline safety laws, or any PHMSA
regulations or orders issued thereunder.
    Pursuant to the 2015 Act, and consistent with the process outlined
in the OMB memorandum titled ``Memorandum for the Heads of Executive
Departments and Agencies: Implementation of the 2017 annual adjustment
pursuant to the Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015,'' M-17-11 (OMB Memorandum M-17-11), PHMSA is
again revising references in these regulations to the maximum civil
penalties for violations. Based on the cost-of-living adjustment
multiplier for 2017, derived from the Consumer Price Index (CPI-U) for
the month of October 2016 (not seasonally adjusted), a multiplier of
1.01636 was used to calculate updated maximum civil penalty amounts.
    The revised penalties are as follows:

----------------------------------------------------------------------------------------------------------------
                                                                 Current maximum civil    Revised maximum civil
           Violated statute                  CFR citation               penalty                  penalty
----------------------------------------------------------------------------------------------------------------
49 U.S.C. 60101 et seq., and any       49 CFR 190.223(a)......  $205,638 for each        $209,002 for each
 regulation or order issued                                      violation for each day   violation for each day
 thereunder.                                                     the violation            the violation
                                                                 continues, with a        continues, with a
                                                                 maximum penalty not to   maximum penalty not to
                                                                 exceed $2,056,380 for    exceed $2,090,022 for
                                                                 a related series of      a related series of
                                                                 violations.              violations.
49 U.S.C. 60103; 49 U.S.C. 60111.....  49 CFR 190.223(c)......  A penalty not to exceed  An administrative civil
                                                                 $75,123 which may be     penalty not to exceed
                                                                 in addition to other     $76,352, which may be
                                                                 penalties under 40       in addition to other
                                                                 U.S.C. 60101, et seq.    penalties assessed
                                                                                under 49 U.S.C. 60101,
                                                                                et seq.
49 U.S.C. 60129......................  49 CFR 190.223(d)......  A penalty not to exceed  A penalty not to exceed
                                                                 $1,194.                  $1,214.
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    The 2015 Act only applies to prospective penalties and does not
retrospectively change any civil penalties previously assessed or
enforced. Further, under the 2015 Act, PHMSA is required to publish
annual inflation adjustments for each penalty levied under 49 U.S.C.
60101, et seq., in the Federal Register no later than January 15 of
each year.
    The 2015 Act does not alter PHMSA's existing authority to assess
penalties levied for violations under 49 U.S.C. 60101, et seq.
Additionally, if future penalties or penalty adjustments are enacted by
statute or regulation, PHMSA will not adjust these penalties for
inflation in the first year after the penalties are in effect. PHMSA
will apply new annual penalty levels to any penalties assessed on or
after the date these new penalty levels take effect.

II. Justification for Final Rule

    PHMSA is proceeding directly to a final rule without providing a
notice of proposed rulemaking or an opportunity for public comment.
This action is permitted, in part, because the 2015 Act directs PHMSA
to adjust the civil monetary penalties in accordance with the schedule
provided in the 2015 Act, notwithstanding the notice and public comment
procedures in the Administrative Procedure Act (APA). However, PHMSA
also notes that the APA authorizes agencies to forego providing the
opportunity for prior public notice and comment if an agency finds good
cause that notice and public procedure are ``impracticable,
unnecessary, or contrary to the public interest'' (5 U.S.C.
553(b)(3)(B)). In this instance, public comment is unnecessary because
by making these technical amendments, PHMSA is not exercising
discretion in a way that could be informed by public comment. PHMSA is
required under the 2015 Act and directed by the OMB Guidance to publish
this final rule by January 15, 2017, with the penalty levels stated
herein slated to take effect on that date. Further, PHMSA is mandated
by the 2015 Act and directed by the OMB Guidance to adjust the penalty
levels pursuant to the specific procedures also stated herein. Any
public comments received through notice and public procedure would
therefore not affect PHMSA's obligation to comply with the 2015 Act,
nor would they affect the methods used by PHMSA to adjust the penalty
levels.

III. Rulemaking Analyses and Notices

A. Statutory/Legal Authority for This Rulemaking

    This final rule is published under the authority of the 2015 Act,
as well 49 U.S.C. 60101, et seq. These statutes provide PHMSA with the
authority to levy civil penalties for violations of Federal pipeline
safety laws. The 2015 Act requires penalties levied by Federal agencies
pursuant to these laws to be adjusted. Beginning in January 2017, the
2015 Act requires such penalties to be adjusted on an annual basis no
later than January 15 of each year.

B. Executive Orders 12866 and 13563, and Department of Transportation
(DOT) Regulatory Policies and Procedures

    This final rule has been evaluated in accordance with existing DOT
policies and procedures and determined to be non-significant under
Executive Order 12866, Regulatory Planning and Review, 58 FR 51735
(October 4, 1993), and Executive Order 13563, Improving Regulation and
Regulatory Review, 76 FR 3821 (January 21, 2011). Consistent with
guidance in OMB Memorandum M-17-11, this final rule is considered to be
a non-significant regulatory action under Executive Order 12866.
Further, this final rule is not significant under the regulatory
policies and procedures of the DOT because it is limited to a
ministerial act in which the agency has no discretion and where the
economic impact of the final rule is minimal (44 FR 11034).
Accordingly, preparation of a regulatory evaluation is not warranted.
    This final rule imposes no new costs upon persons conducting
operations in compliance with Federal pipeline statutes and
regulations. Those operators not in compliance with these statues and
regulations may experience an increased cost based on the penalties
levied against them for non-compliance; however, this is an avoidable,
variable cost and thus is not considered in any evaluation of the
significance of this regulatory action. The amendments in this final
rule could provide a deterrent effect that could potentially lead to
safety benefits; however, PHMSA does not expect such benefits to be
significant. Overall, it is anticipated that costs and benefits from
this final rule would be minimal in real dollars.

C. Executive Order 13132

    PHMSA has analyzed this final rule according to Executive Order
13132 on Federalism, 64 FR 43255 (August 10, 1999). The final rule does
not have a substantial direct effect on the States, the relationship
between the national government and the States, or the distribution of
power and responsibilities among the various levels of government. The
final rule neither imposes substantial direct compliance costs on State
and local governments nor preempts state law governing intrastate
pipelines. Therefore, the consultation and funding requirements of
Executive Order 13132 do not apply.

D. Executive Order 13175

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 on consultation and
coordination with Indian tribal governments, 65 FR 67249 (November 9,
2000). Because the final rule does not have tribal implications, does
not impose substantial direct compliance costs, and is required by
statute, the funding and consultation requirements of Executive Order
13175 do not apply.

E. Executive Order 13211

    This final rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use, 66 FR 28355
(May 22, 2001). It is not likely to have a significant adverse effect
on supply, distribution, or energy use. Further, the Office of
Information and Regulatory Affairs (OIRA) within OMB has not designated
this final rule as a significant energy action.

F. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies

    The Regulatory Flexibility Act, 5 U.S.C. 601-611, requires each
agency to analyze proposed regulations and assess their impact on small
businesses and other small entities to determine whether this final
rule is expected to have a significant impact on a substantial number
of small entities. The provisions of this final rule may apply
specifically to all businesses using pipelines to transport hazardous
liquids, gas, and liquefied natural gas (LNG) in interstate commerce.
Therefore, PHMSA certifies this final rule would not have a significant
economic impact on a substantial number of small entities.

G. Paperwork Reduction Act

    This final rule imposes no new requirements for recordkeeping or
reporting.

H. Unfunded Mandates Reform Act of 1995

    This final rule does not impose unfunded mandates under the
Unfunded Mandates Reform Act of 1995, Public Law 104-4. It does not
result in costs of $100 million or more (adjusted for inflation) in any
year for either State, local, or tribal governments, in the aggregate,
or to the private sector, and is the least burdensome alternative that
achieves the objective of the final rule.

I. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA), as amended,
requires Federal agencies to consider the consequences of major Federal
actions and prepare a detailed statement on actions significantly
affecting the quality of the human environment (42 U.S.C. 4321-4375).
When developing potential regulatory requirements, PHMSA evaluates
those requirements to consider the environmental impact of these
amendments. Specifically, PHMSA evaluates the risk of release and
resulting environmental impact; the risk to human safety, including any
risk to first responders; if the proposed regulation would be carried
out in a defined geographic area; and the resources, especially in
environmentally sensitive areas, that could be impacted by any proposed
regulations.
    This final rule would be generally applicable to pipeline
operators, and would not be carried out in a defined geographic area.
The adjusted, increased civil penalties listed in this final rule may
act as a deterrent to those violating Federal pipeline safety laws, or
any PHMSA regulations or orders issued thereunder. This may result in a
positive environmental impact as a result of increased compliance with
Federal pipeline safety laws and any PHMSA regulations or orders issued
thereunder. Based on the above discussion, PHMSA concludes there are no
significant environmental impacts associated with this final rule.

J. Executive Order 13609 and International Trade Analysis

    Under Executive Order 13609, Promoting International Regulatory
Cooperation, agencies must consider whether the impacts associated with
significant variations between domestic and international regulatory
approaches are unnecessary or may impair the ability of American
business to export and compete internationally, 77 FR 26413 (May 4,
2012). In meeting shared challenges involving health, safety, labor,
security, environmental, and other issues, international regulatory
cooperation can identify approaches that are at least as protective as
those that are or would be adopted in the absence of such cooperation.
International regulatory cooperation can also reduce, eliminate, or
prevent unnecessary differences in regulatory requirements.
    Similarly, the Trade Agreements Act of 1979 (Pub. L. 96-39), as
amended by the Uruguay Round Agreements Act (Pub. L. 103-465),
prohibits Federal agencies from establishing any standards or engaging
in related activities that create unnecessary obstacles to the foreign
commerce of the United States. For purposes of these requirements,
Federal agencies may participate in the establishment of

international standards so long as the standards have a legitimate
domestic objective--such as providing for safety--and do not operate to
exclude imports that meet this objective. The statute also requires
consideration of international standards and, where appropriate, using
them as the basis for U.S. standards.
    PHMSA participates in the establishment of international standards
in order to protect the safety of the American public, and we have
assessed the effects of this final rule to ensure that it does not
cause unnecessary obstacles to foreign trade. Accordingly, this final
rule is consistent with Executive Order 13609 and PHMSA's obligations.

K. Privacy Act

    Anyone is able to search the electronic form of written
communications and comments received into our dockets by the name of
the individual submitting the document (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement, published on April
11, 2000 (65 FR 19476), in the Federal Register at: https://www.gpo.gov/fdsys/pkg/FR-2000-04-11/pdf/00-8505.pdf.

L. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
the spring and fall of each year. The RIN contained in the heading of
this document can be used to cross-reference this action in the Unified
Agenda.

M. Executive Order 13609 and International Trade Analysis

    Sections 3 and 4 of Executive Order 13609 direct an agency to
conduct a regulatory analysis and ensure that a proposed rule does not
cause unnecessary obstacles to foreign trade. This requirement applies
if a rule constitutes a significant regulatory action, or if a
regulatory evaluation must be prepared for the rule. This interim final
rule is not a significant regulatory action, but a regulatory action
under Section 3(e) of Executive Order 12866. PHMSA is not required
under Executive Orders 12866 and 13563 to submit a regulatory analysis.

List of Subjects in 49 CFR Part 190

    Administrative practice and procedure, Penalties, Pipeline safety.

    Accordingly, the interim rule amending 49 CFR part 190 which was
published at 81 FR 42564 on June 30, 2016, is adopted as a final rule
with the following changes:

PART 190--PIPELINE SAFETY ENFORCEMENT AND REGULATORY PROCEDURES

0
1. The authority citation for part 190 continues to read as follows:

    Authority: 33 U.S.C. 1321(b); 49 U.S.C. 60101 et seq.; 49 CFR
1.97; Pub. L. 114-74, section 701; Pub. L. No: 112-90, section 2;
Pub. L. 101-410, sections 4-6.

0
2. In Sec.  190.223 paragraphs (a), (c), and (d) are revised to read as
follows:

Sec.  190.223  Maximum penalties.

    (a) Any person found to have violated a provision of 49 U.S.C.
60101, et seq., or any regulations or orders issued thereunder, is
subject to an administrative civil penalty not to exceed $209,002 for
each violation for each day the violation continues, with a maximum
administrative civil penalty not to exceed $2,090,022 for any related
series of violations.
* * * * *
    (c) Any person found to have violated any standard or order under
49 U.S.C. 60103 is subject to an administrative civil penalty not to
exceed $76,352, which may be in addition to other penalties to which
such person may be subject under paragraph (a) of this section.
    (d) Any person who is determined to have violated any standard or
order under 49 U.S.C. 60129 is subject to an administrative civil
penalty not to exceed $1,214, which may be in addition to other
penalties to which such person may be subject under paragraph (a) of
this section.
* * * * *

    Issued in Washington, DC, on April 24, 2017, under authority
delegated in 49 CFR 1.97.
Howard W. McMillan,
Administrator.
[FR Doc. 2017-08530 Filed 4-26-17; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Pages 57661-57662]
[FR Doc No: 2013-22823]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Agency Information Collection Activities: Announcement of the
Office of Management and Budget (OMB) Control Numbers Under the
Paperwork Reduction Act

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice; announcement of OMB approval of information collection
requirements.

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SUMMARY: The Occupational Safety and Health Administration announces
that the Office of Management and Budget (OMB) extended its approval
for a number of information collection requirements found in sections
of 29 CFR parts 1910, 1915, and 1926. OSHA sought approval of these
requirements under the Paperwork Reduction Act of 1995 (PRA-95), and,
as required by that Act, is announcing the approval numbers and
expiration dates for these requirements.

DATES: This notice is effective September 19, 2013.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, Occupational Safety and Health
Administration, U.S. Department of Labor, Room N-3609, 200 Constitution
Avenue NW., Washington, DC 20210, telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a series of Federal Register notices, the
Agency announced its requests to OMB to renew its current extensions of
approvals for various information collection (paperwork) requirements
in its safety and health standards pertaining to, general industry,
shipyard employment, and the construction industry (i.e., 29 CFR parts
1910, 1915, and 1926), and regulations containing procedures for
handling of retaliation complaints. In these Federal Register
announcements, the Agency provided 60-day comment periods for the
public to respond to OSHA's burden hour and cost estimates.
    In accordance with PRA-95 (44 U.S.C. 3501-3520), OMB renewed its
approval for these information collection requirements, and assigned
OMB control numbers to these requirements. The table below provides the
following information for each of these information collection
requirements approved by OMB: the title of the Federal Register notice;
the Federal Register reference (date, volume, and leading page); OMB's
Control Number; and the new expiration date.

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                                                    Date of Federal Register
  Title of the information collection request     publication, Federal Register     OMB control     Expiration
                                                 reference, and OSHA Docket No.         No.            date
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1,2-Dibromo-3-Chloropropane (DBCP) Standard     04/06/2012, 77 FR 20850, Docket        1218-0101      11/30/2015
 (29 CFR 1910.1044).                             No. 2012-0010.
1,3-Butadiene Standard (29 CFR 1910.1051).....  07/06/2012, 77 FR 40087, Docket        1218-0170      02/29/2016
                                                 No. OSHA-2012-0027.
4,4'-Methylenedianiline for General Industry    01/30/2013, 78 FR 6350, Docket         1218-0184      06/30/2016
 (29 CFR 1910.1050).                             No. OSHA-2012-0040.
4,4'-Methylenedianiline for Construction (29    11/16/2012, 77 FR 68849, Docket        1218-0183      05/31/2016
 CFR 1926.60).                                   No. OSHA-2012-0031.
Asbestos in Shipyards Standard (29 CFR          04/02/2012, 77 FR 19737, Docket        1218-0195      11/30/2015
 1915.1001).                                     No. OSHA-2012-0009.
Benzene (29 CFR 1910.1028)....................  02/28/2013, 78 FR 13707, Docket        1218-0129      06/30/2016
                                                 No. 2013-0008.
Blasting and the Use of Explosives (29 CFR      02/17/2012, 77 FR 9703, Docket         1218-0217      08/31/2015
 part 1926, subpart U).                          No. OSHA-2011-0747.
Cadmium in Construction Standard (29 CFR        03/06/2012, 77 FR 13357, Docket        1218-0186      08/31/2015
 1926.1127).                                     No. OSHA-2012-0004.
Cadmium in General Industry (29 CFR 1910.1027)  03/06/2012, 77 FR 13359, Docket        1218-0185      08/31/2015
                                                 No. OSHA-2012-0005.
Electrical Protective Equipment (29 CFR         01/23/2013, 78 FR 4873, Docket         1218-0190      06/30/2016
 1910.137), and Electric Power Generation,       No. OSHA-2013-0003.
 Transmission, and Distribution (29 CFR
 1910.269).

Hazardous Waste Operations and Emergency        04/30/2012, 77 FR 25500, Docket        1218-0202      11/30/2015
 Response (HAZWOPER) (29 CFR 1910.120).          No. OSHA-2011-0862.
Hexavalent Chromium Standards for General       10/09/2012, 77 FR 61431, Docket        1218-0252      05/31/2016
 Industry (29 CFR 1910.1026), Shipyard           No. OSHA-2012-0034.
 Employment (29 CFR 1915.1026), and
 Construction (29 CFR 1926.1126).
Inorganic Arsenic Standard (29 CFR 1910.1018).  10/20/2011, 76 FR 65217, Docket        1218-0104      03/31/2015
                                                 No. OSHA-2011-0186.
Lead in Construction Standard (29 CFR 1926.62)  08/10/2012, 77 FR 47883, Docket        1218-0189      02/29/2016
                                                 No. OSHA-2012-0014.
Lead in General Industry (29 CFR 1910.1025)...  08/10/2012, 77 FR 47882, Docket        1218-0092      02/29/2016
                                                 No. OSHA-2012-0013.
Occupational Safety and Health Administration   04/26/2012, 77 FR 24992, Docket        1218-0244      12/31/2015
 Strategic Partnership Programs for Worker       No. OSHA-2011-0861.
 Safety and Health (OSPP).
Personal Protective Equipment (PPE) for         01/30/2013, 78 FR 6352, Docket         1218-0205      06/30/2016
 General Industry (29 CFR part 1910 subpart I).  No. OSHA-2013-0004.
Personal Protective Equipment (PPE) for         12/05/2012, 77 FR 72411, Docket        1218-0215      05/31/2016
 Shipyard Employment (29 CFR Part 1915,          No. OSHA-2012-0038.
 subpart I).
Process Safety Management of Highly Hazardous   11/06/2012, 77 FR 66638, Docket        1218-0200      05/31/2016
 Chemicals (PSM) (29 CFR 1910.119).              No. OSHA-2012-0039.
Reports of Injuries to Employees Operating      05/25/2012, 77 FR 31396, OSHA-         1218-0070      10/31/2015
 Mechanical Power Presses (29 CFR 1910.217(g)).  2012-0017.
Temporary Labor Camps (29 CFR 1910.142).......  05/25/2012, 77 FR 31395, OSHA          1218-0096      10/31/2015
                                                 No. 2012-0012.
Walking-Working Surfaces Standard (29 CFR part  02/13/2013, 78 FR 10212, Docket        1218-0199      06/30/2016
 1910, subpart D).                               No. OSHA-2013-0002.
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    In accordance with 5 CFR 1320.5(b), an agency cannot conduct,
sponsor, or require a response to a collection of information unless
the collection displays a valid OMB control number and the agency
informs respondents that they need not respond to the collection of
information unless it displays a valid OMB control number.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is 44 U.S.C. 3506 et seq. and
Secretary of Labor's Order No. 1-2012 (77 FR 3912).

    Signed at Washington, DC, on September 16, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-22823 Filed 9-18-13; 8:45 am]
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