[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2220-2222]
[FR Doc No: 2016-00691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1203]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information To Accompany Humanitarian Device Exemption
Applications and Annual Distribution Number Reporting Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information to accompany
humanitarian device exemption (HDE) applications and the collection of
information regarding the annual distribution number (ADN).

DATES: Submit either electronic or written comments on the collection
of information by March 15, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2012-N-1203 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Information to Accompany
Humanitarian Device Exemption Applications and Annual Distribution
Number Reporting Requirements''. Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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''. The Agency 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to 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 this 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Information To Accompany Humanitarian Device Exemption Applications and
Annual Distribution Number Reporting Requirements--OMB Control Number
0910-0661--Extension

    Under section 520(m) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(m)), FDA is authorized to exempt a
humanitarian use device (HUD) from the effectiveness requirements in
sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided
that the device: (1) Is used to treat or diagnose a disease or
condition that affects fewer than 4,000 individuals in the United
States; (2) would not be available to a person with such a disease or
condition unless the exemption is granted, and there is no comparable
device, other than another HUD approved under this exemption, available
to treat or diagnose the disease or condition; (3) the device will not
expose patients to an unreasonable or significant risk of illness or
injury; and (4) the probable benefit to health from using the device
outweighs the risk of injury or illness from its use, taking into
account the probable risks and benefits of currently available devices
or alternative forms of treatment.
    HUDs approved under an HDE cannot be sold for an amount that
exceeds the costs of research and development, fabrication, and
distribution of the device (i.e., for profit), except in narrow
circumstances. Section 613 of the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July
9, 2012, amended section 520(m) of the FD&C Act. Under section
520(m)(6)(A)(i) of the FD&C Act, as amended by FDASIA, a HUD approved
under an HDE is eligible to be sold for profit if the device meets the
following criteria: The device is intended for the treatment or
diagnosis of a disease or condition that occurs in pediatric patients
or in a pediatric subpopulation, and such device is labeled for use in
pediatric patients or in a pediatric subpopulation in which the disease
or condition occurs; or the device is intended for the treatment or
diagnosis of a disease or condition that does not occur in pediatric
patients, or that occurs in pediatric patients in such numbers that the
development of the device for such patients is impossible, highly
impracticable, or unsafe.
    Section 520(m)(6)(A)(ii) of the FD&C Act, as amended by FDASIA,
provides that the Secretary of Health and Human Services will assign an
ADN for devices that meet the eligibility criteria to be permitted to
be sold for profit. The ADN is defined as the number of devices

``reasonably needed to treat, diagnose, or cure a population of 4,000
individuals in the United States'', and therefore shall be based on the
following information in a HDE application: The number of devices
reasonably necessary to treat such individuals.
    Section 520(m)(6)(A)(iii) of the FD&C Act (http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm) provides that an HDE holder
immediately notify the Agency if the number of devices distributed
during any calendar year exceeds the ADN. Section 520(m)(6)(C) of the
FD&C Act provides that an HDE holder may petition to modify the ADN if
additional information arises.
    On August 5, 2008, FDA issued a guidance entitled ``Guidance for
HDE Holders, Institutional Review Boards (IRBs), Clinical
Investigators, and Food and Drug Administration Staff--Humanitarian
Device Exemption (HDE) Regulation: Questions and Answers'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf). The guidance was developed and issued
prior to the enactment of FDASIA, and certain sections of this guidance
may no longer be current as a result of FDASIA. In the Federal Register
of March 18, 2014 (79 FR 15130), FDA announced the availability of the
draft guidance entitled ``Humanitarian Device Exemption: Questions and
Answers; Draft Guidance for Humanitarian Device Exemption Holders,
Institutional Review Boards, Clinical Investigators, and Food and Drug
Administration Staff'', that when finalized, will represent FDA's
current thinking on this topic.
    FDA is requesting the extension of OMB approval for the collection
of information required under the statutory mandate of sections 515A
(21 U.S.C. 360e-1) and 520(m) of the FD&C Act as amended.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of
Activity/section of FD&C Act (as     Number of     responses per   Total annual   Average burden    Total hours
       amended) or FDASIA           respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Pediatric Subpopulation and                    6               1               6             100             600
 Patient Information--515A(a)(2)
 of the FD&C Act................
Exemption from Profit                          3               1               3              50             150
 Prohibition Information--
 520(m)(6)(A)(i) and (ii) of the
 FD&C Act.......................
Request for Determination of                   2               1               2              10              20
 Eligibility Criteria--613(b) of
 FDASIA.........................
ADN Notification--                             1               1               1             100             100
 520(m)(6)(A)(iii) of the FD&C
 Act............................
ADN Modification--520(m)(6)(C)                 5               1               5             100             500
 of the FD&C Act................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,370
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's Center for Devices and Radiological Health receives an
estimated average of six HDE applications per year. FDA estimates that
three of these applications will be indicated for pediatric use. We
estimate that we will receive approximately two requests for
determination of eligibility criteria per year. FDA estimates that very
few or no HDE holders will notify the Agency that the number of devices
distributed in the year has exceeded the ADN. FDA estimates that five
HDE holders will petition to have the ADN modified due to additional
information on the number of individuals affected by the disease or
condition.

    Dated: January 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00691 Filed 1-14-16; 8:45 am]
 BILLING CODE 4164-01-P


Nitrogen Dioxide NAAQS Public Hearing

August 3, 2009

Testimony of

Howard J. Feldman

American Petroleum Institute

Good morning. I am Howard J. Feldman, director of Regulatory and
Scientific Affairs at API. API is the primary trade association for the
oil and gas industry, with more than 400 members, and as you all know,
we've been very active in the NAAQS process through the years.

I want to make two points today: First, the oil and gas industry is
helping the air get cleaner today and in the future; and, second,
there's no need for a short-term NO2 standard in the range which EPA has
proposed.

So API wants to thank all of us as a society for improving the air
quality. Since 1990, the oil and gas industry has invested more than
$175 billion -- that's billion, with a "B," -- towards improving the
environmental performance of its products, facilities, and operations.
Approximately 57 percent of the industry’s $14 billion environmental
expenditures in 2007 targeted air pollution abatement, meeting or
surpassing the requirements of the Clean Air Act.  We've put in place
cleaner gasoline and cleaner diesel, and these fuels, along with cleaner
equipment, cleaner cars, trucks, and buses are really leading to and
will continue to lead to cleaner air quality. We've also worked with
local and state governments to reduce the emissions from our facilities.

EPA’s trends data (my Figure 1) show that the emissions from six
criteria air pollutants dropped by 60 percent between 1970 and 2008,
while vehicle miles traveled (VMT) went up 163 percent. So we're seeing
real progress and real growth, so that's very good.  According to
EPA’s Toxics Release Inventory (TRI), since 1988 releases and
transfers of toxic chemicals from the petroleum industry have decreased
by 65 percent. All this progress is going to continue. EPA is reworking
programs that will lead to power plant reduction in the eastern US of 60
percent in the reduction in emissions. Cleaner gasoline in cars and
trucks will lead to 77 to 95 percent cleaner products, including lower
emissions going forward. And reductions will come into place as the
engines turn to Ultra Low Sulfur Diesel; that will effectively be a 90
percent reduction due to Ultra Low Sulfur Diesel. So we see progress
will continue.

Let’s focus on nitrogen dioxide, the issue before us today.

According to EPA (my Figure 2), from 1990 to 2006, there has been a 29%
decrease in emissions of nitrogen oxides. And given the control programs
already mentioned, this will continue for years to come.  Has this made
a difference in air quality?  The answer is an unqualified YES. Figure 3
shows that the last time there was an exceedance of the current NO2
standard (annual) was 1991, and from 1980 to 2008 there has been a 46%
decrease in the National average NO2 levels! So NO2 levels have gone
downward and will continue to decline over the next decade.

The question we come to now is whether we need a new, short-term NO2
standard in the range which EPA has proposed.  If it is intended to
simply reduce concentrations, we clearly have been doing that without
the standard.  So the question is whether it is needed to address a
particular health effect.

Apparently, EPA is relying on an unpublished “meta-analysis” to
support the need for the short term NO2 standard.  As we will hear from
Dr. Seeley of Gradient, Gradient has conducted more rigorous
meta-analyses and meta-regressions than EPA, including 10 additional
studies, and found that there is no evidence to suggest that NO2 leads
to a significant adverse effect on the response to an airway challenge
at any of the exposures tested in the range of the proposed standard.
Therefore, there is no need for a new, short-term NO2 standard in the
range proposed by the Administrator is needed to protect the public
health.

Also, we ask EPA to respond to the points raised in the June 2, 2009
Request for Corrections on the NO2 ISA submitted by the National
Association of Manufacturers (NAM).  NAM’s petition includes eight
items questioning the accuracy, objectivity, consistency and
transparency of the process conducted by EPA.  Specifically, one item
NAM requests is that EPA prepare and release a report that includes a
detailed description and justification of the methodology for the
unpublished "meta-analysis" of short-term NO2 exposure included in the
Final ISA.  This EPA meta-analysis is central to the science used by the
Agency in the proposal and without documentation and peer review the
results are less than robust.  We would certainly expect to see this
released by an Administration which has highlighted the need for
increased transparency in its actions.

One technical point I’d like to raise is the issue of the design of
the monitoring network.  With only one or two exceptions the current
monitors are located in the community, not along major roadways.  EPA
has suggested that many more monitors are needed near roadways.  Careful
planning to gather data in the first generation of monitor locations
will be needed to fine tune the network to properly capture exposures
both in and near roadways.  Therefore the January 1, 2013 deadline for
the monitor locations may be too aggressive to identify, implement and
adjust a defensible monitoring network.  So we suggest that EPA build
some additional time into that deadline.

In closing, API wishes to once again acknowledge the efforts of EPA, the
states and local communities in providing cleaner air. Looking forward,
further improvements will come through current regulations designed to
meet the existing standards, such as cleaner fuels described above. Of
course, we all know that the Clean Air Act mandates that the NO2 NAAQS
be established based solely on science. Nevertheless, given the dramatic
nitrogen dioxide reductions already accomplished and which will
continue, the potential impacts of tightening this standard on control
programs and industry should highlight the importance of getting the
science right, and not establishing a new standard in the range
proposed.  Therefore we encourage EPA to reassess the proposed rule and
base it on a complete, scientific analysis and to ensure that the public
is provided a reasonable opportunity to review that analysis.

Thank you.

Figure 1. Comparison of Growth Areas and Emissions, 1970-2008

Figure 2.

Figure 3.

Figure 4.

Page |   PAGE   \* MERGEFORMAT  3                 		Feldman testimony

		August 3, 2009


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on March 17, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-2000-8299

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Air Japan Co., Ltd.						Date Filed:  February 26, 2003

Relief requested: Renew exemption from 49 U.S.C. § 41301 to engage in
scheduled foreign air transportation of persons, property and mail
between any point or points in Japan and any point or points in the
United States; and to conduct charters in accordance with Part 212 of
our rules.

Date and citation of last action:  March 6, 2002, in this docket

Applicant representative:  Charles J. Simpson, Jr.<PHONE_NUMBER>

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Responsive pleadings:  None filed

	DISPOSITION

Action:  Approved									Action date:  March 17, 2003

Effective dates of authority granted:  March 17, 2003-March 17, 2004

Basis for approval (bilateral agreement/reciprocity):  1998 Memorandum
of Understanding between the United States and Japan (1998 MOU).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X Standard exemption conditions (attached)

Special conditions/Partial grant/Denial basis/Remarks:

Under the authority granted above, Air Japan must (1) comply with the
prior approval requirements for charters set forth in the Notice of
Action Taken, dated February 27, 2001, in this docket, and (2) perform
all services consistent with existing agreements between the United
States and Japan.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

												        Appendix A

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITY

In the conduct of the operations authorized, the holder shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security;1

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are:

   (a)  based on its operations in international air transportation
that, according to the contract of carriage, include a point in the
United States as a point of origin, point of destination, or agreed
stopping place, or for which the contract of carriage was purchased in
the United States; or

   (b)  based on a claim under any international agreement or treaty
cognizable in any court or other tribunal of the United States.

In this condition, the term "international air transportation" means
"international transportation" as defined by the Warsaw Convention,
except that all States shall be considered to be High Contracting
Parties for the purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code (formerly the
Federal Aviation Act of 1958, as amended).

__________________

1  To assure compliance with all applicable U.S. Government requirements
concerning security, the holder should, before commencing any new
service (including charter flights) from a foreign airport that would be
the holder’s last point of departure for the United States, inform its
Principal Security Inspector of its plans.

U.S. Department of Transportation

Office of the Secretary of Transportation									        (41301/40109)
10/2002