[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Pages 65560-65564]
[FR Doc No: 2012-26494]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0559]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Public Health Service
Guideline on Infectious Disease Issues in Xenotransplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
November 28, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0456.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

PHS Guideline on Infectious Disease Issues in Xenotransplantation--(OMB
Control Number 0910-0456)--Extension

    The statutory authority to collect this information is provided
under sections 351 and 361 of the Public Health Service (PHS) Act (42
U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and
Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq.). The PHS
guideline recommends procedures to diminish the risk of transmission of
infectious agents to the xenotransplantation product recipient and to
the general public. The PHS guideline is intended to address public
health issues raised by xenotransplantation, through identification of
general principles of prevention and control of infectious diseases
associated with xenotransplantation that may pose a hazard to the
public health. The collection of information described in this
guideline is intended to provide general guidance on the following
topics: (1) The development of xenotransplantation clinical protocols;
(2) the preparation of submissions to FDA; and (3) the conduct of
xenotransplantation clinical trials. Also, the collection of
information will help ensure that the sponsor maintains important
information in a cross-referenced system that links the relevant
records of the xenotransplantation product recipient,
xenotransplantation product, source animal(s), animal procurement
center, and significant nosocomial exposures. The PHS

guideline describes an occupational health service program for the
protection of health care workers involved in xenotransplantation
procedures, caring for xenotransplantation product recipients, and
performing associated laboratory testing. The PHS guideline is intended
to protect the public health and to help ensure the safety of using
xenotransplantation products in humans by preventing the introduction,
transmission, and spread of infectious diseases associated with
xenotransplantation.
    The PHS guideline also recommends that certain specimens and
records be maintained for 50 years beyond the date of the
xenotransplantation. These include: (1) Records linking each
xenotransplantation product recipient with relevant health records of
the source animal, herd or colony, and the specific organ, tissue, or
cell type included in or used in the manufacture of the product
(<IP_ADDRESS>); (2) aliquots of serum samples from randomly selected animal
and specific disease investigations (<IP_ADDRESS>); (3) source animal
biological specimens designated for PHS use (3.7.1); animal health
records (3.7.2), including necropsy results (3.6.4); and (4)
recipients' biological specimens (4.1.2). The retention period is
intended to assist health care practitioners and officials in
surveillance and in tracking the source of an infection, disease, or
illness that might emerge in the recipient, the source animal, or the
animal herd or colony after a xenotransplantation.
    The recommendation for maintaining records for 50 years is based on
clinical experience with several human viruses that have presented
problems in human to human transplantation and are therefore thought to
share certain characteristics with viruses that may pose potential
risks in xenotransplantation. These characteristics include long
latency periods and the ability to establish persistent infections.
Several also share the possibility of transmission among individuals
through intimate contact with human body fluids. Human immunodeficiency
virus (HIV) and Human T-lymphotropic virus are human retroviruses.
Retroviruses contain ribonucleic acid that is reverse-transcribed into
deoxyribonucleic acid (DNA) using an enzyme provided by the virus and
the human cell machinery. That viral DNA can then be integrated into
the human cellular DNA. Both viruses establish persistent infections
and have long latency periods before the onset of disease, 10 years and
40 to 60 years, respectively. The human hepatitis viruses are not
retroviruses, but several share with HIV the characteristic that they
can be transmitted through body fluids, can establish persistent
infections, and have long latency periods, e.g., approximately 30 years
for Hepatitis C.
    In addition, the PHS guideline recommends that a record system be
developed that allows easy, accurate, and rapid linkage of information
among the specimen archive, the recipient's medical records, and the
records of the source animal for 50 years. The development of such a
record system is a one-time burden. Such a system is intended to cross-
reference and locate relevant records of recipients, products, source
animals, animal procurement centers, and nosocomial exposures.
    Respondents to this collection of information are the sponsors of
clinical studies of investigational xenotransplantation products under
investigational new drug applications (INDs) and xenotransplantation
product procurement centers, referred to as source animal facilities.
There are an estimated two respondents who are sponsors of INDs that
include protocols for xenotransplantation in humans. Other respondents
for this collection of information are an estimated four source animal
facilities that provide source xenotransplantation product material to
sponsors for use in human xenotransplantation procedures. These four
source animal facilities keep medical records of the herds/colonies as
well as the medical records of the individual source animal(s). The
total annual reporting and recordkeeping burden is estimated to be
approximately 45 hours. The burden estimates are based on FDA's records
of xenotransplantation-related INDs and estimates of time required to
complete the various reporting, recordkeeping, and third-party
disclosure tasks described in the PHS guideline.
    FDA is requesting an extension of OMB approval for the following
reporting, recordkeeping, and third-party disclosure recommendations in
the PHS guideline:

                   Table 1--Reporting Recommendations
------------------------------------------------------------------------
    PHS Guideline section                     Description
------------------------------------------------------------------------
<IP_ADDRESS>......................  Notify sponsor or FDA of new archive site
                                when the source animal facility or
                                sponsor ceases operations.
------------------------------------------------------------------------

                 Table 2--Recordkeeping Recommendations
------------------------------------------------------------------------
    PHS Guideline section                     Description
------------------------------------------------------------------------
3.2.7........................  Establish records linking each
                                xenotransplantation product recipient
                                with relevant records.
4.3..........................  Sponsor to maintain cross-referenced
                                system that links all relevant records
                                (recipient, product, source animal,
                                animal procurement center, and
                                nosocomial exposures).
3.4.2........................  Document results of monitoring program
                                used to detect introduction of
                                infectious agents which may not be
                                apparent clinically.
<IP_ADDRESS>......................  Document full necropsy investigations
                                including evaluation for infectious
                                etiologies.
3.5.1........................  Justify shortening a source animal's
                                quarantine period of 3 weeks prior to
                                xenotransplantation product procurement.
3.5.2........................  Document absence of infectious agent in
                                xenotransplantation product if its
                                presence elsewhere in source animal does
                                not preclude using it.
3.5.4........................  Add summary of individual source animal
                                record to permanent medical record of
                                the xenotransplantation product
                                recipient.
3.6.4........................  Document complete necropsy results on
                                source animals (50-year record
                                retention).
3.7..........................  Link xenotransplantation product
                                recipients to individual source animal
                                records and archived biologic specimens.
<IP_ADDRESS>......................  Record baseline sera of
                                xenotransplantation health care workers
                                and specific nosocomial exposure.
<IP_ADDRESS> and 4.3.2............  Keep a log of health care workers'
                                significant nosocomial exposure(s).
4.3.1........................  Document each xenotransplant procedure.

5.2..........................  Document location and nature of archived
                                PHS specimens in health care records of
                                xenotransplantation product recipient
                                and source animal.
------------------------------------------------------------------------

                   Table 3--Disclosure Recommendations
------------------------------------------------------------------------
    PHS Guideline section                     Description
------------------------------------------------------------------------
<IP_ADDRESS>......................  Notify sponsor or FDA of new archive site
                                when the source animal facility or
                                sponsor ceases operations.
3.4..........................  Standard operating procedures (SOPs) of
                                source animal facility should be
                                available to review bodies.
3.5.1........................  Include increased infectious risk in
                                informed consent if source animal
                                quarantine period of 3 weeks is
                                shortened.
3.5.4........................  Sponsor to make linked records described
                                in section 3.2.7 available for review.
3.5.5........................  Source animal facility to notify sponsor
                                when infectious agent is identified in
                                source animal or herd after
                                xenotransplantation product procurement.
------------------------------------------------------------------------

    In the Federal Register of June 14, 2012 (77 FR 35683), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment from the public.
The comment was not responsive to the comment request on the four
specified aspects of the collection of information and did not provide
any data or explanation that would support a change regarding the
information collection requirements.
    FDA estimates the burden for this collection of information as
follows:

                                 Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
     PHS Guideline section          No. of       responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS> \2\...................               1               1               1  0.50 (30                    0.50
                                                                                minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ FDA is using one animal facility or sponsor for estimation purposes.

                               Table 5--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of                       Average burden
     PHS Guideline section          No. of        records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
3.2.7 \2\.....................               1               1               1  16..............              16
4.3 \3\.......................               2               1               2  0.75 (45                    1.50
                                                                                minutes).
3.4.2 \4\.....................               2              16              32  0.25 (15                       8
                                                                                minutes).
<IP_ADDRESS> \5\...................               2               4               8  0.25 (15                       2
                                                                                minutes).
3.5.1 \6\.....................               2            0.50               1  0.50 (30                    0.50
                                                                                minutes).
3.5.2 \6\.....................               2            0.50               1  0.25 (15                    0.25
                                                                                minutes).
3.5.4.........................               2               1               2  0.17 (10                    0.34
                                                                                minutes).
3.6.4 \7\.....................               2               4               8  0.25 (15                       2
                                                                                minutes).
3.7 \7\.......................               4               2             8.0  0.08 (5 minutes)            0.64
<IP_ADDRESS> \8\...................               2              25              50  0.17 (10                    8.50
                                                                                minutes).
<IP_ADDRESS> \6\...................               2            0.50               1  0.17 (10                    0.17
                                                                                minutes).
<IP_ADDRESS> and 4.3.2 \6\.........               2            0.50               1  0.17 (10                    0.17
                                                                                minutes).
4.3.1.........................               2               1               2  0.25 (15                    0.50
                                                                                minutes).
5.2 \9\.......................               2               6              12  0.08 (5 minutes)            0.96
                                                                                ---------------
    Total.....................  ..............  ..............  ..............  ................           41.53
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is
  using one new sponsor for estimation purposes.
\3\ FDA estimates there is minimal recordkeeping burden associated with maintaining the record system.
\4\ Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are
  approximately 6 sentinel animals per herd x 1 herd per facility x 4 facilities = 24 sentinel animals. There
  are approximately 8 source animals per year (see footnote 7 of this table); 24 + 8 = 32 monitoring records to
  document.
\5\ Necropsy for animal deaths of unknown cause estimated to be approximately 2 per herd per year x 1 herd per
  facility x 4 facilities = 8.
\6\ Has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
\7\ On overage 2 source animals are used for preparing xenotransplantation product material for one recipient.
  The average number of source animals is 2 source animals per recipient x 4 recipients annually = 8 source
  animals per year. (See footnote 5 of table 3 of this document.)
\8\ FDA estimate there re approximately 2 clinical centers doing xenotransplantation procedure x approximately
  25 health care workers involved per center = 50 health care workers.
\9\ Eight source animal records + 4 recipient records = 12 total records.

                           Table 6--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
     PHS Guideline section          No. of        disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS> \2\...................               1            1                  1  0.50 (30                    0.50
                                                                                minutes).
3.4 \3\.......................               4            0.50               2  0.08 (5 minutes)            0.16
3.5.1 \4\.....................               4            0.25               1  0.25 (15                    0.25
                                                                                minutes).
3.5.4 \5\.....................               4            1                  4  0.50 (30                    2
                                                                                minutes).
3.5.5 \4\.....................               4            0.25               1  0.25 (15                    0.25
                                                                                minutes).
                                                                                ---------------
    Total.....................  ..............  ..............  ..............  ................            3.16
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ FDA is using one animal facility or sponsor for estimation purposes.
\3\ FDA's records indicate that an average of two INDs is expected to be submitted per year.
\4\ To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
\5\ Based on an estimate of 12 patients treated over a 3-year period, the average number of xenotransplantation
  produce recipients per year is estimated to be 4.

    Because of the potential risk for cross-species transmission of
pathogenic persistent virus, the guideline recommends that health
records be retained for 50 years. Since these records are medical
records, the retention of such records for up to 50 years is not
information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of
the limited number of clinical studies with small patient populations,
the number of records is expected to be insignificant at this time.
    Information collections in this guideline not included in tables 1
through 6 can be found under existing regulations and approved under
the OMB control numbers as follows: (1) ``Current Good Manufacturing
Practice for Finished Pharmaceuticals,'' 21 CFR 211.1 through 211.208,
approved under OMB control number 0910-0139; (2) ``Investigational New
Drug Application,'' 21 CFR 312.1 through 312.160, approved under OMB
control number 0910-0014; and; (3) information included in a biologics
license application, 21 CFR 601.2, approved under OMB control number
0910-0338. (Although it is possible that a xenotransplantation product
may not be regulated as a biological product (e.g., it may be regulated
as a medical device), FDA believes, based on its knowledge and
experience with xenotransplantation, that any xenotransplantation
product subject to FDA regulation within the next 3 years will most
likely be regulated as a biological product.) However, FDA recognized
that some of the information collections go beyond approved
collections; assessments for these burdens are included in tables 1
through 6.
    In table 7 of this document, FDA identifies those collection of
information activities that are already encompassed by existing
regulations or are consistent with voluntary standards which reflect
industry's usual and customary business practice.

                Table 7--Collection of Information Required by Current Regulations and Standards
----------------------------------------------------------------------------------------------------------------
                                        Description of collection of information      21 CFR Section (unless
         PHS Guideline section                          activity                         otherwise stated)
----------------------------------------------------------------------------------------------------------------
2.2.1.................................  Document offsite collaborations.........  312.52
2.5...................................  Sponsor ensures counseling patient +      312.62(c)
                                         family + contacts..
3.1.1 and 3.1.6.......................  Document well-characterized health        312.23(a)(7)(a) and 211.84
                                         history and lineage of source animals.
3.1.8.................................  Registration with and import permit from  42 CFR 71.53
                                         the Centers for Disease Control and
                                         Prevention.
3.2.2.................................  Document collaboration with accredited    312.52
                                         microbiology labs..
3.2.3.................................  Procedures to ensure the humane care of   9 CFR parts 1, 2, and 3 and
                                         animals..                                 PHS Policy \1\
3.2.4.................................  Procedures consistent for accreditation   AAALAC International Rules of
                                         by the Association for Assessment and     Accreditation \2\ and NRC
                                         Accreditation of Laboratory Animal Care   Guide \3\
                                         International (AAALAC International)
                                         and consistent with the National
                                         Research Council's (NRC) Guide.
3.2.5, 3.4, and 3.4.1.................  Herd health maintenance and surveillance  211.100 and 211.122
                                         to be documented, available, and in
                                         accordance with documented procedures;
                                         record standard veterinary care.
3.2.6.................................  Animal facility SOPs....................  PHS Policy \1\
3.3.3.................................  Validate assay methods..................  211.160(a)
3.6.1.................................  Procurement and processing of xenografts  211.100 and 211.122
                                         using documented aseptic conditions.
3.6.2.................................  Develop, implement, and enforce SOPs for  211.84(d) and 211.122(c)
                                         procurement and screening processes.
3.6.4.................................  Communicate to FDA animal necropsy        312.32(c)
                                         findings pertinent to health of
                                         recipient.
3.7.1.................................  PHS specimens to be linked to health      312.23(a)(6)
                                         records; provide to FDA justification
                                         for types of tissues, cells, and
                                         plasma, and quantities of plasma and
                                         leukocytes collected.
4.1.1.................................  Surveillance of xenotransplant            312.23(a)(6)(iii)(f) and (g),
                                         recipient; sponsor ensures                and 312.62(b) and (c)
                                         documentation of surveillance program
                                         life-long (justify >2 years);
                                         investigator case histories (2 years
                                         after investigation is discontinued).

4.1.2.................................  Sponsor to justify amount and type of     211.122
                                         reserve samples..
<IP_ADDRESS>...............................  System for prompt retrieval of PHS        312.57(a)
                                         specimens and linkage to medical
                                         records (recipient and source animal).
<IP_ADDRESS>...............................  Notify FDA of a clinical episode          312.32
                                         potentially representing a xenogeneic
                                         infection.
<IP_ADDRESS>...............................  Document collaborations (transfer of      312.52
                                         obligation)..
<IP_ADDRESS>...............................  Develop educational materials (sponsor    312.50
                                         provides investigators with information
                                         needed to conduct investigation
                                         properly)..
4.3...................................  Sponsor to keep records of receipt,       312.57 and 312.62(b)
                                         shipment, and disposition of
                                         investigative drug; investigator to
                                         keep records of case histories.
----------------------------------------------------------------------------------------------------------------
\1\ The ``Public Health Service Policy on Humane Care and Use of Laboratory Animals'' (http://www.grants.nih.gov/grants/olaw/references/phspol.htm).
\2\ AAALAC International Rules of Accreditation (http://www.aaalac.org/accreditation/rules.cfm).
\3\ The NRC's ``Guide for the Care and Use of Laboratory Animals.''

    Dated: October 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-26494 Filed 10-26-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Pages 63849-63850]
[FR Doc No: 2012-25569]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2012-0855]

National Offshore Safety Advisory Committee

AGENCY: United States Coast Guard

ACTION: Committee Management; Notice of Federal Advisory Committee
Meetings.

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SUMMARY: The National Offshore Safety Advisory Committee (NOSAC) will
meet on November 7 and 8, 2012, in Houston, TX to discuss various
issues related to safety of operations and other matters affecting the
oil and gas offshore industry. These meetings are open to the public.

DATES: NOSAC will meet Wednesday, November 7, 2012, from 1 p.m. to 5
p.m. and Thursday, November 8, 2012, from 8:30 a.m. to 5 p.m. Two
subcommittees will meet the afternoon of November 7. Please note that
the meetings may close early if the committee has completed its
business or be extended based on the level of public comments.

ADDRESSES: The meetings will be held at the Marriott South Hobby
Airport Hotel, 9100 Gulf Freeway, Houston, TX 77017, http://www.marriott.com/houhh. The November 7 afternoon subcommittee meetings
will be held in the Corpus Christi room. The November 8 meeting will
also be held at Marriott South Hobby Airport Hotel, in the Corpus
Christi/South Padre Rooms.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in FOR FURTHER INFORMATION CONTACT as soon as
possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
``AGENDA'' section below. Comments must be submitted in writing no
later than October 25, 2012, and must be identified by USCG-2012-0855
and may be submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
     To avoid duplication, please use only one of these
methods.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to

this Notice, go to http://www.regulations.gov, insert USCG-2011-0855 in
the Keyword ID box, press Enter, and then click on the item you are
interested in viewing.
    A public comment period will be held during the meeting on November
8, 2012, and speakers are requested to limit their comments to 3
minutes. Please note that the public comment period may end before the
time indicated, following the last call for comments. Contact one of
the individuals listed below to register as a speaker.

FOR FURTHER INFORMATION CONTACT: Commander Rob Smith, Designated
Federal Officer of NOSAC, Commandant (CG-OES-2), U.S. Coast Guard, 2100
Second Street SW., Stop 7126, Washington, DC 20593-0001; telephone
(202) 372-1410, fax<PHONE_NUMBER>, or Mr. Scott Hartley, Alternate
Designated Federal Officer of NOSAC, Commandant (CG-OES-2), U.S. Coast
Guard, 2100 Second Street SW., Stop 7126, Washington, DC 20593-0001;
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>. If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). The
National Offshore Safety Advisory Committee (NOSAC) provides advice and
recommendations to the Department of Homeland Security on matters and
actions concerning activities directly involved with or in support of
the exploration of offshore mineral and energy resources insofar as
they relate to matters within U.S. Coast Guard jurisdiction.

Agenda

Day 1

    NOSAC's two subcommittees will meet on November 7, 2012, between 1
p.m. and 5 p.m., to discuss its ongoing work. Times for these meetings
are as follows: (1) Standards for Dynamic Positioning (DP) Operating
Personnel (1 p.m. to 3:00 p.m.) and (2) Review of the Mississippi
Canyon Block 252 Incident Reports stemming from the Deepwater Horizon
casualty event (3:00 p.m. to 5 p.m.).

Day 2

    The NOSAC will meet on November 8, 2012, to review and discuss
reports and recommendations received from the two subcommittees from
their deliberations on November 7. The Committee will use this
information and consider public comments in formulating final
recommendations to the agency. Public comments or questions will be
taken at the discretion of the DFO during the discussion and
recommendations portion of the meeting as well as during the public
comment period, see Agenda item (13). A complete agenda for November
8th is as follows:
    (1) Committee Administration;
    (2) Welcoming comments from USCG;
    (3) Presentation and discussion of Reports and Recommendations from
the subcommittees and subsequent actions on:
    (a) Standards for DP Operating Personnel; and
    (b) Mississippi Canyon Block 252 Incident Reports.
    (4) An update on recent U.S. Coast Guard (USCG) regulations and
Federal Register notices that affect the offshore industry;
    (5) An update on recent Bureau of Safety and Environmental
Enforcement (BSEE) regulations, Federal Register notices and Notice to
Lessees;
    (6) A USCG Perspective on Arctic Activities;
    (7) USCG Voluntary Operational Dynamic Positioning Guidelines;
    (8) USCG National Center of Expertise, Outer Continental Shelf
(OCS) Inspections;
    (9) Updates on International Maritime Organization (IMO) activities
of interest to the OCS community;
    (10) American Petroleum Institute's Center for Offshore Safety
Strategic Plan and Future Activities;
    (11) Quality of USCG Inspections on the OCS/Overview of USCG's
mission management system program;
    (12) Task Statement discussion of Standards for Accommodation
Service Vessels;
    (13) Period for Public comment; and
    (14) Adjournment of meeting.
    A copy of each report is available at the https://www.fido.gov Web
site or by contacting Scott Hartley. Use ``code 68'' to identify NOSAC
when accessing this material through the Web site. Once you have
accessed the Committee page, click on the meetings tab and then the
``View'' button for the meeting dated November 8, 2012, to access the
information for this meeting. Minutes will be available approximately
30 days after this meeting. Both minutes and documents applicable for
this meeting can also be found at an alternative site using the
following web address: https://homeport.uscg.mil/NOSAC.
    A transcript of the meeting and any material presented at the
meeting will be made available through the https://www.fido.gov Web
site.
    The committee will review the information presented on each issue,
deliberate on any recommendations presented in the subcommittees'
reports, and formulate recommendations for the Department's
consideration.
    The committee will also receive tasking from CDR Rob Smith,
Designated Federal Officer, on one proposed task statement: Standards
for Accommodation Service Vessels. The committee will make
recommendations to the U.S. Coast Guard concerning this task.

    Dated: October 11, 2012.
F.J. Sturm,
Acting Director of Commercial Regulations and Standards.
[FR Doc. 2012-25569 Filed 10-16-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Page 80359]
[FR Doc No: 2015-32511]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9940-53-ORD; Docket ID No. EPA-HQ-ORD-2013-0357]

Draft Integrated Science Assessment for Sulfur Oxides--Health
Criteria

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of public comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day extension of the public comment period for the draft document
titled, ``External Review Draft Integrated Science Assessment for
Sulfur Oxides--Health Criteria'' (EPA/600/R-15/066). The original
Federal Register notice announcement provides a 60-day public comment
period and was published on November 24, 2015. The EPA subsequently
received a request to extend this comment period. With the 30-day
extension announced in this notice, the comment period ends on February
24, 2016. The draft document was prepared by the National Center for
Environmental Assessment (NCEA) within the EPA's Office of Research and
Development as part of the review of the primary (health-based)
National Ambient Air Quality Standards for sulfur dioxide.

DATES: The public comment period began on November 24, 2015, and ends
on February 24, 2016. Comments must be received on or before February
24, 2016.

ADDRESSES: The ``External Review Draft Integrated Science Assessment
for Sulfur Oxides--Health Criteria'' will be available primarily via
the Internet on the EPA's Integrated Science Assessment for Sulfur
Dioxide (Health Criteria) home page at http://www2.epa.gov/isa/integrated-science-assessment-isa-sulfur-dioxide-health-criteria or the
public docket at http://www.regulations.gov, Docket ID: EPA-HQ-ORD-
2013-0357. A limited number of CD-ROM copies will be available. Contact
Ms. Marieka Boyd by phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>to request a CD-ROM, and please provide your name,
your mailing address, and the document title, ``External Review Draft
Integrated Science Assessment for Sulfur Oxides--Health Criteria'' to
facilitate processing of your request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Dr.
Tom Long, NCEA; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Comments may be submitted electronically via
http://www.regulations.gov, by mail, by fax, or by hand delivery/
courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of the Federal Register notice
announcing the release of the draft assessment document, published on
November 24, 2015 (80 FR 73183).
    For information on submitting comments to the docket, please
contact the ORD Docket at the EPA's Headquarters Docket Center;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>
    Dated: December 16, 2015.
Mary A. Ross,
Deputy Director, National Center for Environmental Assessment.
[FR Doc. 2015-32511 Filed 12-23-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43145-43146]
[FR Doc No: 2019-17932]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3722]

Bone, Reproductive and Urologic Drugs Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Bone, Reproductive and
Urologic Drugs Advisory Committee. The general function of the
committee is to provide advice and recommendations to FDA on regulatory
issues. The meeting will be open to the public. FDA is establishing a
docket for public comment on this document.

DATES: The meeting will be held on October 30, 2019, from 8:15 a.m. to
5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-3722. The docket will close on October
29, 2019. Submit either electronic or written comments on this public
meeting by October 29, 2019. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before October 29, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of October 29, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before October 16, 2019, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3722 for ``Bone, Reproductive and Urologic Drugs Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
the ADDRESSES section), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss new drug application (NDA)
204017 (levonorgestrel and ethinyl estradiol) transdermal system,
submitted by Agile Therapeutics, Inc., for the prevention of pregnancy
in women of reproductive potential.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before October 16, 2019, will be provided to
the committee. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 7, 2019. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 8, 2019.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Kalyani Bhatt (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17932 Filed 8-19-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Rules and Regulations]
[Pages 38036-38039]
[FR Doc No: 2018-16605]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2010-1086; FRL-9979-68-OLEM]
RIN 2050-AG67

Addition of a Subsurface Intrusion Component to the Hazard
Ranking System; Corrections

AGENCY: Environmental Protection Agency (EPA).

ACTION: Correcting amendments.

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

SUMMARY: On January 9, 2017, the Environmental Protection Agency
published a final rule which added subsurface intrusion component to
the Superfund Hazard Ranking System. That document inadvertently failed
to update the Table of Contents and contained a few other typographical
errors. This document corrects the final regulation.

DATES: This correction is effective August 3, 2018.

FOR FURTHER INFORMATION CONTACT: Terry Jeng, phone:<PHONE_NUMBER>,
email: [email protected], Site Assessment and Remedy Decisions Branch,
Assessment and Remediation Division, Office of Superfund Remediation
and Technology Innovation (Mailcode 5204P), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460.

SUPPLEMENTARY INFORMATION: This is EPA's erratum to the final rule
titled Addition of a Subsurface Intrusion Component to the Hazard
Ranking System, published January 9, 2017 (82 FR 2760). This is the
second set of corrections. The first set of corrections was published
in the Federal Register on January 31, 2018 (83 FR 4430). This document
augments those corrections.
    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(3)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. See Utility Solid Waste
Activities Group v. EPA, 236 F.3d 749, 752 (D.C. Cir. 2001). We have
determined that there is good

cause for making these correcting amendments final without prior
proposal and opportunity for public comment. Notice and comment is
unnecessary because these administrative or clerical corrections govern
the methodology of how EPA, rather than the public or industry,
evaluates contaminated sites under the Hazard Ranking System.
Similarly, notice and comment is impracticable and contrary to the
public interest because the correcting amendments will more quickly
ensure that EPA is following the proper procedures to evaluate
potential threats to public health from releases of hazardous
substances, pollutants, or contaminants. Thus, good cause exists to
proceed without notice and public comment.
    These correcting amendments are effective immediately upon
publication. Section 553(d) of the APA, 5 U.S.C. 553(d), provides that
final rules shall not become effective until 30 days after publication
in the Federal Register, ``except . . . as otherwise provided by the
agency for good cause,'' among other exceptions. The purpose of this
provision is to ``give affected parties a reasonable time to adjust
their behavior before the final rule takes effect.'' Omnipoint Corp. v.
FCC, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v.
Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative
history). Thus, in determining whether good cause exists to waive the
30-day delay, an agency should ``balance the necessity for immediate
implementation against principles of fundamental fairness which require
that all affected persons be afforded a reasonable amount of time to
prepare for the effective date of its ruling.'' Gavrilovic, 551 F.2d at
1105. EPA has determined that there is good cause for making these
correcting amendments effective immediately because, as stated above,
the corrections govern how EPA, rather than the public or industry,
applies the Hazard Ranking System to evaluate potential threats to
public health from releases of hazardous substances, pollutants, or
contaminants. Accordingly, EPA finds that good cause exists under
section 553(d)(3) to make this rule effective immediately upon
publication.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Oil pollution, Penalties, Reporting and
recordkeeping requirements, Superfund, Water pollution control, Water
supply.

    Dated: June 29, 2018.
Barry N. Breen,
Acting Assistant Administrator, Office of Land and Emergency
Management.

    40 CFR part 300 is corrected as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p.351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

0
2. Amend Appendix A to Part 300 by:
0
a. In the Table of Contents revising the entries for ``5.0'' through
``5.3''; and
0
b. Revising Table 2-5, Table 5-16, and Table 7-1.
    The revisions read as follows:

Appendix A to Part 300--The Hazard Ranking System

Table of Contents

List of Figures
List of Tables
* * * * *
    5.0 Soil Exposure and Subsurface Intrusion Pathway.
    5.0.1 Exposure components.
    5.1 Soil exposure component.
    5.1.0 General considerations.
    5.1.1 Resident population threat.
    <IP_ADDRESS> Likelihood of exposure.
    <IP_ADDRESS> Waste characteristics.
    <IP_ADDRESS>.1 Toxicity.
    <IP_ADDRESS>.2 Hazardous waste quantity.
    <IP_ADDRESS>.3 Calculation of waste characteristics factor category
value.
    <IP_ADDRESS> Targets.
    <IP_ADDRESS>.1 Resident individual.
    <IP_ADDRESS>.2 Resident population.
    <IP_ADDRESS>.2.1 Level I concentrations.
    <IP_ADDRESS>.2.2 Level II concentrations.
    <IP_ADDRESS>.2.3 Calculation of resident population factor value.
    <IP_ADDRESS>.3 Workers.
    <IP_ADDRESS>.4 Resources.
    <IP_ADDRESS>.5 Terrestrial sensitive environments.
    <IP_ADDRESS>.6 Calculation of resident population targets factor
category value.
    <IP_ADDRESS> Calculation of resident population threat score.
    5.1.2 Nearby population threat.
    <IP_ADDRESS> Likelihood of exposure.
    <IP_ADDRESS>.1 Attractiveness/accessibility.
    <IP_ADDRESS>.2 Area of contamination.
    <IP_ADDRESS>.3 Likelihood of exposure factor category value.
    <IP_ADDRESS> Waste characteristics.
    <IP_ADDRESS>.1 Toxicity.
    <IP_ADDRESS>.2 Hazardous waste quantity.
    <IP_ADDRESS>.3 Calculation of waste characteristics factor category
value.
    <IP_ADDRESS> Targets.
    <IP_ADDRESS>.1 Nearby individual.
    <IP_ADDRESS>.2 Population within 1 mile.
    <IP_ADDRESS>.3 Calculation of nearby population targets factor
category value.
    <IP_ADDRESS> Calculation of nearby population threat score.
    5.1.3 Calculation of soil exposure component score.
    5.2 Subsurface intrusion component.
    5.2.0 General considerations.
    5.2.1 Subsurface intrusion component.
    <IP_ADDRESS> Likelihood of exposure.
    <IP_ADDRESS>.1 Observed exposure.
    <IP_ADDRESS>.2 Potential for exposure.
    <IP_ADDRESS>.2.1 Structure containment.
    <IP_ADDRESS>.2.2 Depth to contamination.
    <IP_ADDRESS>.2.3 Vertical migration.
    <IP_ADDRESS>.2.4 Vapor migration potential.
    <IP_ADDRESS>.2.5 Calculation of potential for exposure factor value.
    <IP_ADDRESS>.3 Calculation of likelihood of exposure factor category
value.
    <IP_ADDRESS> Waste characteristics.
    <IP_ADDRESS>.1 Toxicity/degradation.
    <IP_ADDRESS>.1.1 Toxicity.
    <IP_ADDRESS>.1.2 Degradation.
    <IP_ADDRESS>.1.3 Calculation of toxicity/degradation factor value.
    <IP_ADDRESS>.2 Hazardous waste quantity.
    <IP_ADDRESS>.3 Calculation of waste characteristics factor category
value.
    <IP_ADDRESS> Targets.
    <IP_ADDRESS>.1 Exposed individual.
    <IP_ADDRESS>.2 Population.
    <IP_ADDRESS>.2.1 Level I concentrations.
    <IP_ADDRESS>.2.2 Level II concentrations.
    <IP_ADDRESS>.2.3 Population within area(s) of subsurface
contamination.
    <IP_ADDRESS>.2.4 Calculation of population factor value.
    <IP_ADDRESS>.3 Resources.
    <IP_ADDRESS>.4 Calculation of targets factor category value.
    5.2.2 Calculation of subsurface intrusion component score.
    5.3 Calculation of the soil exposure and subsurface intrusion
pathway score.
* * * * *

                            Table 2-5--Hazardous Waste Quantity Evaluation Equations
----------------------------------------------------------------------------------------------------------------
                                                                                Equation  for assigning
            Tier                      Measure                      Units                      value \a\
----------------------------------------------------------------------------------------------------------------
A...........................  Hazardous constituent    lb..........................  C.
                               quantity (C).
B \b\.......................  Hazardous wastestream    lb..........................  W/5,000.
                               quantity (W).

C \b\.......................  Volume (V).............
                              Landfill...............  yd\3\.......................  V/2,500.
                              Surface impoundment....  yd\3\.......................  V/2.5.
                              Surface impoundment      yd\3\.......................  V/2.5.
                               (buried/backfilled).
                              Drums \c\..............  gallon......................  V/500.
                              Tanks and containers     yd\3\.......................  V/2.5.
                               other than drums.
                              Contaminated soil......  yd\3\.......................  V/2,500.
                              Pile...................  yd\3\.......................  V/2.5.
                              Other..................  yd\3\.......................  V/2.5.
D \b\.......................  Area (A)...............
                              Landfill...............  ft\2\.......................  A/3,400.
                              Surface impoundment....  ft\2\.......................  A/13.
                              Surface impoundment      ft\2\.......................  A/13.
                               (buried/backfilled).
                              Land treatment.........  ft\2\.......................  A/270.
                              Pile \d\...............  ft\2\.......................  A/13.
                              Contaminated soil......  ft\2\.......................  A/34,000.
----------------------------------------------------------------------------------------------------------------
\a\ Do not round to nearest integer.
\b\ Convert volume to mass when necessary: 1 ton = 2,000 pounds = 1 cubic yard = 4 drums = 200 gallons.
\c\ If actual volume of drums is unavailable, assume 1 drum=50 gallons.
\d\ Use land surface area under pile, not surface area of pile.

* * * * *

       Table 5-16--Values for Vapor Pressure and Henry's Constant
------------------------------------------------------------------------
                                                        Assigned  value
------------------------------------------------------------------------
Vapor Pressure (Torr):
    Greater than 10..................................                  3
    1 to 10..........................................                  2
    Less than 1......................................                  0
Henry's Constant (atm-m\3\/mol):
    Greater than 10 -\3\.............................                  3
    Greater than 10 -\4\ to 10 -\3\..................                  2
    10 -\5\ to 10 -\4\...............................                  1
    Less than 10 -\5\................................                  0
------------------------------------------------------------------------

* * * * *

                                                                 Table 7-1--HRS Factors Evaluated Differently for Radionuclides
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Subsurface
                                                     Surface water                        Soil exposure                          intrusion
      Ground water  pathway         Status \a\          pathway          Status \a\    component of  SESSI    Status \a\       component of       Status \a\       Air pathway       Status \a\
                                                                                pathway                           SESSI pathway
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Likelihood of                                     Likelihood of......                     Likelihood of                        Likelihood of                   Likelihood of.....
Release                                           Release............                  Exposure...........                  Exposure..........                 Release...........
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Observed Release................  Yes...........  Observed Release...  Yes...........  Observed             Yes...........  Observed Exposure.  Yes..........  Observed Release..  Yes.
                                                                                Contamination.
Potential to Release............  No............  Potential to         No............  Attractiveness/      No............  Potential for       Yes..........  Gas Potential to    No.
                                                   Release.                             Accessibility to                     Exposure.                          Release.
                                                                                Nearby Residents.
Containment.....................  No............  Overland Flow        No............  Area of              No............  Structure           No...........  Gas Containment...  No.
                                                   Containment.                         Contamination.                       Containment.
Net Precipitation...............  No............  Runoff.............  No............  ...................  ..............  Depth to            Yes..........  Gas Source Type...  No.
                                                                                Contamination.
Depth to Aquifer................  No............  Distance to Surface  No............  ...................  ..............  Vertical migration  No...........  Gas Migration       No.
                                                   water.                                                                                Potential.
Travel Time.....................  No............  Flood Frequency....  No............  ...................  ..............  Vapor Migration     No...........  Particulate         No.
                                                                                Potential.                         Potential to
                                                                                Release.
                                                  Flood Containment..  No............  ...................  ..............  Area of Observed    No...........  Particulate         No.
                                                                                Exposure.                          Containment.
                                                                                Area of Subsurface  No...........  Particulate Source  No.
                                                                                Contamination.                     Type.
                                                                                Particulate         No.
                                                                                Migration
                                                                                Potential.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Waste                                             Waste..............                  Waste..............                  Waste.............                 Waste.............  .............
Characteristics                                   Characteristics....                  Characteristics....                  Characteristics...                 Characteristics...
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Toxicity........................  Yes...........  Toxicity/            Yes/Yes.......  Toxicity...........  Yes...........  Toxicity/           Yes/Yes......  Toxicity..........  Yes.
                                                   Ecotoxicity.                                                              Degradation.
Mobility........................  No............  Persistence/         Yes/No........  Hazardous Waste      Yes...........  Hazardous Waste     Yes..........  Mobility..........  No.
                                                   Mobility.                            Quantity.                            Quantity.
Hazardous Waste Quantity........  Yes...........  Bioaccumulation      No............  ...................  ..............  ..................  .............  Hazardous Waste     Yes.
                                                   Potential.                                                                                Quantity.
                                                  Hazardous Waste      Yes...........
                                                   Quantity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Targets                                           Targets............                  Targets............                  Targets...........                 Targets...........
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nearest Well....................  Yes \b\.......  Nearest Intake.....  Yes \b\.......  Resident Individual  Yes \b\.......  Exposed Individual  Yes \b\......  Nearest Individual  Yes.\b\
Population......................  Yes \b\.......  Drinking Water       Yes \b\.......  Resident Population  Yes \b\.......  Population........  Yes \b\......  Population........  Yes.\b\
                                                   Population.
Resources.......................  No............  Resources..........  No............  Workers............  No............  Resources.........  No...........  Resources.........  No.
Wellhead Protection Area........  No............  Sensitive            Yes \b\.......  Resources..........  No............  ..................  .............  Sensitive           No.
                                                   Environments.                                                                                Environments.
                                                  Human Food Chain     Yes \b\.......  Terrestrial          No............
                                                   Individual.                          Sensitive
                                                                                Environments.
                                                  Human Food Chain     Yes \b\.......  Nearby Individual..  No............
                                                   Population.                         Population Within 1  No............
                                                                                Mile.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
a--Factors evaluated differently are denoted by ``yes''; factors not evaluated differently are denoted by ``no''.
b--Difference is in the determination of Level I and Level II concentrations.

* * * * *
[FR Doc. 2018-16605 Filed 8-2-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45356-45360]
[FR Doc No: 2017-20796]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2017-0018 (Notice No. 2017-05)]

Hazardous Materials: Information Collection Activities

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on 11 information collections pertaining to hazardous
materials transportation for which PHMSA intends to request renewal
from the Office of Management and Budget. On April 21, 2017, PHMSA
published a notice with a 60-day comment period soliciting comments on
these ICRs [82 FR 18828] under Docket No. PHMSA-2017-0018 (Notice No.
2017-01). PHMSA received one comment; however, it was outside the scope
of the April 21, 2017, notice.

DATES: Interested persons are invited to submit comments on or before
October 30, 2017.

ADDRESSES: You may submit comments identified by Docket No. PHMSA-2017-
0018 (Notice No. 2017-05) by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management System; U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: To the Docket Management System; Room W12-
140 on the ground floor of the West Building, 1200 New Jersey Avenue
SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    Instructions: All submissions must include the agency name and
Docket Number (PHMSA-2017-0018) for this notice at the beginning of the
comment. To avoid duplication, please use only one of these four
methods. All comments received will be posted without change to the
Federal Docket Management System (FDMS) and will include any personal
information you provide.
    Requests for a copy of an information collection should be directed
to Steven Andrews or T. Glenn Foster, Standards and Rulemaking
Division,<PHONE_NUMBER>, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590-0001.
    Docket: For access to the dockets to read background documents or
comments received, go to http://www.regulations.gov or DOT's Docket
Operations Office (see ADDRESSES).
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Steven Andrews or T. Glenn Foster,
Standards and Rulemaking Division,<PHONE_NUMBER>, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), title 5, Code of Federal
Regulations (CFR) requires PHMSA to provide interested members of the
public and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies
information collection requests that PHMSA will be submitting to the
Office of Management and Budget (OMB) for renewal and extension. These
information collections are contained in 49 CFR 171.6 of the Hazardous
Materials Regulations (HMR; 49 CFR parts 171-180). PHMSA has revised
burden estimates, where appropriate, to reflect current reporting
levels or adjustments based on changes in proposed or final rules
published since the information collections were last approved. The
following is provided for each information collection: (1) Title of the
information collection, including former title if a change is being
made; (2) OMB control number; (3) summary of the information collection
activity; (4) description of affected public; (5) estimate of total
annual reporting and recordkeeping burden; and (6) frequency of
collection. PHMSA will request a 3-year term of approval for each
information collection activity and will publish a notice in the
Federal Register upon OMB's approval.
    PHMSA requests comments on the following 11 information
collections:
    1. Title: Hazardous Materials Security Plans.
    OMB Control Number: 2137-0612.
    Summary: To assure public safety, shippers and carriers must take
reasonable measures to plan and implement procedures to prevent
unauthorized persons from taking control of, or attacking, hazardous
materials shipments. Part 172 of the HMR requires persons who offer or
transport certain hazardous materials to develop and implement written
plans to enhance the security of hazardous materials shipments. The
security plan requirements as prescribed in Sec.  172.800(b) apply to
specific types of shipments. Such shipments include but are not limited
to: Shipments greater than 3,000 kg (6,614 pounds) for solids or 3,000
liters (792 gallons) for liquids and gases in a single packaging such
as a cargo tank motor vehicle, portable tank, tank car, or other bulk
container; any quantity of a Division 1.1, 1.2, or 1.3 material; a
large bulk quantity of a Division 2.1 material; or any quantity of a
poison-by-inhalation material. A security plan reduces the possibility
that a hazardous materials shipment will be used as a weapon of
opportunity by a terrorist or criminal.
    Affected Public: Shippers and carriers of hazardous materials in
commerce.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 54,999.
    Total Annual Responses: 54,999.
    Total Annual Burden Hours: 427,719.
    Frequency of Collection: On occasion.
    2. Title: Rulemaking, Special Permits, and Preemption Requirements.
    OMB Control Number: 2137-0051.
    Summary: This information collection applies to procedures for
requesting changes, exceptions, and other determinations in relation to
the HMR. Specific areas covered in this information collection include
part 105, subparts A and B, ``Hazardous Materials Program Definitions
and General Procedures''; part 106, subpart B, ``Participating in the
Rulemaking Process''; part 107, subpart B, ``Special Permits''; and
part 107, subpart C, ``Preemption.'' The Federal hazardous materials
transportation law directs the Secretary of Transportation to prescribe
regulations for the safe transportation of hazardous materials in
commerce. PHMSA is authorized to accept petitions for rulemaking and
appeals, as well as applications for special permits, preemption
determinations, and waivers of preemption. The types of information
collected include:
    (1) Petitions for Rulemaking: Any person may petition PHMSA to add,
amend, or delete a regulation in parts 110, 130, 171 through 180, or
may petition the Office of the Chief Counsel to add, amend, or delete a
regulation in parts 105, 106, or 107. Petitions submitted to PHMSA are
required to contain information as required by Sec.  106.100 of the
HMR.
    (2) Appeals: Except as provided in Sec.  106.40(e), any person may
submit an appeal to our actions in accordance with the Appeals
procedures found in Sec. Sec.  106.110 through 106.130.
    (3) Applications for Special Permit: Any person applying for a
special permit must include the citation of the specific regulation
from which the applicant seeks relief; specification of

the proposed mode or modes of transportation; detailed description of
the proposed special permit (e.g., alternative packaging, test,
procedure, or activity), including as appropriate, written
descriptions, drawings, flow charts, plans and other supporting
documents, etc.
    (4) Applications for Preemption Determination: With the exception
of highway routing matters covered under 49 U.S.C. 5125(c), any person
directly affected by any requirement of a State, political subdivision,
or Indian tribe may apply to the Chief Counsel for a determination
whether that requirement is preempted by Sec.  107.202(a), (b), or (c).
The application must include the text of the State, political
subdivision, or Indian tribe requirement for which the determination is
sought; specify each requirement of the Federal hazardous materials
transportation law, regulations issued under the Federal hazardous
material transportation law, or hazardous material transportation
security regulations or directives issued by the Secretary of Homeland
Security with which the applicant seeks the State, political
subdivision, or Indian tribe requirement to be compared; explain why
the applicant believes the State, political subdivision, or Indian
tribe requirement should or should not be preempted under the standards
of Sec.  107.202; and state how the applicant is affected by the State,
political subdivision, or Indian tribe requirement.
    (5) Waivers of Preemption: With the exception of requirements
preempted under 49 U.S.C. 5125(c), any person may apply to the Chief
Counsel for a waiver of preemption with respect to any requirement
that: (1) The State, political subdivision thereof, or Indian tribe
acknowledges to be preempted under the Federal hazardous materials
transportation law, or (2) has been determined by a court of competent
jurisdiction to be so preempted. The Chief Counsel may waive preemption
with respect to such requirement upon a determination that such
requirement affords an equal or greater level of protection to the
public than is afforded by the requirements of the Federal hazardous
materials transportation law or the regulations issued thereunder, and
does not unreasonably burden commerce.
    The information collected under these application procedures is
used in the review process by PHMSA in determining the merits of the
petitions for rulemakings and for reconsideration of rulemakings, as
well as applications for special permits, preemption determinations,
and waivers of preemption to the HMR. The procedures governing these
petitions for rulemaking and for reconsideration of rulemakings are
covered in subpart B of part 106. Applications for special permits,
preemption, determinations, and waivers of preemption are covered under
subparts B and C of part 107. Rulemaking procedures help PHMSA
determine if a rule change is necessary, is consistent with public
interest, and maintains a level of safety equal to or superior to that
of current regulations. Special permit procedures provide the
information required for analytical purposes to determine if the
requested relief provides for a comparable level of safety as provided
by the HMR. Additionally, PHMSA uses information from preemption
procedures to determine whether a requirement of a State, political
subdivision, or Indian tribe is preempted under 49 U.S.C. 5125, or
regulations issued thereunder, or whether a waiver of preemption should
be issued.
    Affected Public: Shippers, carriers, packaging manufacturers, and
other affected entities.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 3,304.
    Total Annual Responses: 4,294.
    Total Annual Burden Hours: 4,899.
    Frequency of Collection: On occasion.
    3. Title: Requirements for United Nations (UN) Cylinders.
    OMB Control Number: 2137-0621.
    Summary: This information collection and recordkeeping burden is
the result of efforts to amend the HMR to adopt standards for the
design, construction, maintenance, and use of cylinders and multiple-
element gas containers (MEGCs) based on the standards contained in the
UN Recommendations on the Transport of Dangerous Goods. Aligning the
HMR with the UN Recommendations promotes flexibility, permits the use
of technological advances for the manufacture of the pressure
receptacles, provides for a broader selection of pressure receptacles,
reduces the need for special permits, and facilitates international
commerce in the transportation of compressed gases. Information
collection requirements address domestic and international
manufacturers of cylinders that request approval by the approval agency
for cylinder design types. The approval process for each cylinder
design type includes review, filing, and recordkeeping of the approval
application. The approval agency is required to maintain a set of the
approved drawings and calculations for each design it reviews and a
copy of each initial design type approval certificate approved by the
Associate Administrator for the Office of Hazardous Materials Safety
for not less than 20 years.
    Affected Public: Fillers, owners, users, and retesters of UN
cylinders.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 50.
    Total Annual Responses: 150.
    Total Annual Burden Hours: 900.
    Frequency of Collection: On occasion.
    4. Title: Response Plans for Shipments of Oil.
    OMB Control Number: 2137-0591.
    Summary: In recent years, several major oil discharges damaged the
marine environment of the United States. Under authority of the Federal
Water Pollution Control Act, as amended by the Oil Pollution Act of
1990, PHMSA issued regulations in 49 CFR part 130 that require
preparation of written spill response plans.
    Affected Public: Carriers that transport oil in bulk, by motor
vehicle or rail.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 8,000.
    Total Annual Responses: 8,000.
    Total Annual Burden Hours: 10,560.
    Frequency of Collection: On occasion.
    5. Title: Cargo Tank Specification Requirements.
    OMB Control Number: 2137-0014.
    Summary: This information collection consolidates and describes the
information collection provisions in parts 107, 178, and 180 of the HMR
involving the manufacture, qualification, maintenance, and use of all
specification cargo tank motor vehicles. It also includes the
information collection and recordkeeping requirements for persons who
are engaged in the manufacture, assembly, requalification, and
maintenance of DOT specification cargo tank motor vehicles. The types
of information collected include:
    (1) Registration Statements: Cargo tank manufacturers and
repairers, as well as cargo tank motor vehicle assemblers, are required
to be registered with DOT and must furnish information relative to
their qualifications to perform the functions in accordance with the
HMR. DOT uses the registration statements to identify these persons to
ensure they possess the knowledge and skills necessary to perform the
required functions and that they are performing the specified functions
in accordance with the applicable regulations.
    (2) Requalification and Maintenance Reports: These reports are
prepared by

persons who requalify or maintain cargo tanks. This information is used
by cargo tank owners, operators and users, and DOT compliance personnel
to verify that the cargo tanks are requalified, maintained, and in
proper condition for the transportation of hazardous materials.
    (3) Manufacturers' Data Reports, Certificates, and Related Papers:
These reports are prepared by cargo tank manufacturers and certifiers.
They are used by cargo tank owners, operators, users, and DOT
compliance personnel to verify that a cargo tank motor vehicle was
designed and constructed to meet all requirements of the applicable
specification.
    Affected Public: Manufacturers, assemblers, repairers,
requalifiers, certifiers, and owners of cargo tanks.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 41,366.
    Total Annual Responses: 132,600.
    Total Annual Burden Hours: 101,507.
    Frequency of Collection: On occasion.
    6. Title: Container Certification Statements.
    OMB Control Number: 2137-0582.
    Summary: Shippers of explosives, in freight containers or transport
vehicles by vessel, are required to certify on shipping documentation
that the freight container or transport vehicle meets minimal
structural serviceability requirements. This requirement ensures an
adequate level of safety for transport of explosives aboard vessel and
consistency with similar requirements in international standards.
    Affected Public: Shippers of explosives in freight containers or
transport vehicles by vessel.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 650.
    Total Annual Responses: 890,000.
    Total Annual Burden Hours: 14,908.
    Frequency of Collection: On occasion.
    7. Title: Testing Requirements for Non-Bulk Packaging.
    OMB Control Number: 2137-0572.
    Summary: This information collection consolidates and describes the
information provisions in parts 173 and 180 of the HMR on the testing
requirements for non-bulk packagings. This OMB control number covers
performance-oriented packaging standards and allows packaging
manufacturers and shippers increased flexibility in selecting more
economical packagings for their products. This information collection
also allows customizing the design of packagings to better suit the
transportation environment that they will encounter and encourages
technological innovations, decreases packaging costs, and significantly
reduces the need for special permits.
    Affected Public: Each non-bulk packaging manufacturer that tests
packagings to ensure compliance with the HMR.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 5,010.
    Total Annual Responses: 15,500.
    Total Annual Burden Hours: 32,500.
    Frequency of Collection: On occasion.
    8. Title: Testing, Inspection, and Marking Requirements for
Cylinders.
    OMB Control Number: 2137-0022.
    Summary: Requirements in Sec.  173.301 for qualification,
maintenance, and use of cylinders include periodic inspections and
retesting to ensure continuing compliance with packaging standards.
Information collection requirements address registration of retesters
and marking of cylinders by retesters with their identification number
and retest date following the completion of required tests. The
cylinder owner or designated agent must keep records showing the
results of inspections and retests either until expiration of the
retest period or until the cylinder is re-inspected or retested,
whichever occurs first. These requirements ensure that retesters have
the qualifications to perform tests and identify to cylinder fillers
and users that cylinders are qualified for continuing use. Information
collection requirements in Sec.  173.303 require that fillers of
acetylene cylinders keep, for at least 30 days, a daily record of the
representative pressure to which cylinders are filled.
    Affected Public: Fillers, owners, users, and retesters of reusable
cylinders.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 139,352.
    Total Annual Responses: 153,287.
    Total Annual Burden Hours: 171,462.
    Frequency of Collection: On occasion.
    9. Title: Flammable Cryogenic Liquids.
    OMB Control Number: 2137-0542.
    Summary: Provisions in Sec.  177.840(a)(2) specify certain safety
procedures and documentation requirements for drivers of motor vehicles
transporting flammable cryogenic liquids. This information allows the
driver to take appropriate remedial actions to prevent a catastrophic
release of the flammable cryogenics should the temperature of the
material begin to rise excessively or if the travel time will exceed
the safe travel time. These requirements are intended to ensure a high
level of safety when transporting flammable cryogenics due to their
extreme flammability and high compression ratio when in a liquid state.
    Affected Public: Carriers of cryogenic materials.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 65.
    Total Annual Responses: 18,200.
    Total Annual Burden Hours: 1,213.
    Frequency of Collection: On occasion.
    10. Title: Approval for Hazardous Materials.
    OMB Control Number: 2137-0557.
    Summary: Without these requirements, there is no means to: (1)
Determine whether applicants who apply to become designated approval
agencies are qualified to evaluate package design, test packages,
classify hazardous materials, etc.; (2) verify that various containers
and special loading requirements for vessels meet the requirements of
the HMR; and (3) assure that regulated hazardous materials pose no
danger to life and property during transportation.
    There are several approval provisions contained in the HMR and
associated procedural regulations. Responses to these information
collections are required to obtain benefits, such as becoming an
approval or certification agency, or to obtain a variance from
packaging or handling requirements based on information provided by the
respondent. These benefits and variances involve areas, for example,
such as UN third-party certification; authorization to examine and test
lighters; authorization to examine and test explosives; and
authorization to re-qualify DOT cylinders.
    Affected Public: Business and other entities who must meet the
approval requirements in the HMR.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 14,323.
    Total Annual Responses: 14,674.
    Total Annual Burden Hours: 30,070.
    Frequency of Collection: On occasion.
    11. Title: Rail Carrier and Tank Car Tanks Requirements, Rail Tank
Car Tanks--Transportation of Hazardous Materials by Rail.
    OMB Control Number: 2137-0559.
    Summary: This information collection consolidates and describes the
information provisions in parts 172, 173, 174, 179, and 180 of the HMR
on the transportation of hazardous materials by rail and the
manufacture, qualification, maintenance, and use of tank cars. The
types of information collected include:
    (1) Approvals of the Association of American Railroads (AAR) Tank
Car Committee: An approval is required

from the AAR Tank Car Committee for a tank car to be used for a
commodity other than those specified in part 173 and on the certificate
of construction. This information is used to ascertain whether a
commodity is suitable for transportation in a tank car. AAR approval is
also required for an application for approval of designs, materials and
construction, conversion or alteration of tank car tanks constructed to
a specification in part 179, or an application for construction of tank
cars to any new specification. This information is used to ensure that
the design, construction, or modification of a tank car or the
construction of a tank car to a new specification is performed in
accordance with the applicable requirements.
    (2) Progress Reports: Each owner of a tank car that is required to
be modified to meet certain requirements specified in Sec.  173.31 must
submit a progress report to the Federal Railroad Administration (FRA).
FRA uses this information to ensure that all affected tank cars are
modified before the regulatory compliance date.
    (3) FRA Approvals: An approval is required from FRA to transport a
bulk packaging (such as a portable tank, IM portable tank, intermediate
bulk container, cargo tank, or multi-unit tank car tank) containing a
hazardous material in container-on-flat-car or trailer-on-flat-car
service other than as authorized by Sec.  174.63. FRA uses this
information to ensure that the bulk package is properly secured using
an adequate restraint system during transportation. An FRA approval is
also required for the movement of any tank car that does not conform to
the applicable requirements in the HMR. These latter movements are
currently being reported under the information collection for special
permit applications.
    (4) Manufacturer Reports and Certificate of Construction: These
documents are prepared by tank car manufacturers and used by owners,
users, and FRA personnel to verify that rail tank cars conform to the
applicable specification.
    (5) Quality Assurance Program: Facilities that build, repair, and
ensure the structural integrity of tank cars are required to develop
and implement a quality assurance program. This information is used by
the facility and DOT compliance personnel to ensure that each tank car
is constructed or repaired in accordance with the applicable
requirements.
    (6) Inspection Reports: A written report must be prepared and
retained for each tank car that is inspected and tested in accordance
with Sec.  180.509 of the HMR. Rail carriers, users, and FRA use this
information to ensure that rail tank cars are properly maintained and
in safe condition for transporting hazardous materials.
    Affected Public: Manufacturers, owners, and rail carriers of tank.
    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 266.
    Total Annual Responses: 17,685.
    Total Annual Burden Hours: 2,834.
    Frequency of Collection: Annually.

William S. Schoonover,
Associate Administrator of Hazard Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2017-20796 Filed 9-27-17; 8:45 am]
 BILLING CODE 4910-60-P