[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Proposed Rules]
[Pages 2388-2393]
[FR Doc No: 2018-00646]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10 and 800

[Docket No. FDA-2016-N-2378]
RIN 0910-AH37

Internal Agency Review of Decisions; Requests for Supervisory
Review of Certain Decisions Made by the Center for Devices and
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
implement regulations regarding internal agency supervisory review of
certain decisions related to devices regulated by the Center for
Devices and Radiological Health (CDRH) under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) to conform to the applicable provisions in
the Food and Drug Administration Safety and Innovation Act (FDASIA) and
the 21st Century Cures Act (Cures Act). FDA is taking this action to
codify the procedures and timeframes for supervisory review of
significant decisions pertaining to devices within CDRH. FDA is also
proposing regulations to provide new procedural requirements for
requesting internal agency supervisory review within CDRH of other
types of decisions made by CDRH not addressed in FDASIA and the Cures
Act. This action is also part of FDA's implementation of Executive
Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively
reviewing existing regulations to identify opportunities for repeal,
replacement, or modification that will result in meaningful burden
reduction, while allowing the Agency to achieve its public health
mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments by April 17, 2018.
See section V of this document for the proposed effective date of a
final rule that may issue based on this proposal.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 17, 2018. 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.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal Rulemaking 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 Docket No. FDA-
2016-N-2378 for ``Internal Agency Review of Decisions; Requests for
Supervisory Review of Certain Decisions Made by the Center for Devices
and Radiological Health.'' Received comments, those filed in a timely
manner (see ADDRESSES) 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.'' 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: 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: Adaeze Teme, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5574, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or the Ombudsman for the Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
4282, Silver Springs, MD 20993-0002,<PHONE_NUMBER>, or
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Proposed Rule

    The purpose of this proposed rule is to implement regulations on
the procedures regarding internal agency supervisory review of certain
decisions made by CDRH under the FD&C Act. Section 603 of FDASIA added
new section 517A to the FD&C Act (21 U.S.C. 360g-1), which was amended
by

sections 3051 and 3058 of the Cures Act. These provisions established
procedures and timeframes for supervisory review under Sec.  10.75 (21
CFR 10.75) of significant decisions by CDRH pertaining to devices.
After the enactment of FDASIA, FDA issued a guidance document entitled
``Center for Devices and Radiological Health Appeals Processes:
Questions and Answers About 517A--Guidance for Industry and Food and
Drug Administration Staff'' (Q&A Guidance) to provide interpretation of
key provisions of section 517A, including those that pertain to
requests for supervisory review of significant decisions by CDRH (Ref.
1). FDA is proposing this regulation to codify (1) the procedures and
timeframes for Sec.  10.75 appeals of ``significant decisions'' by CDRH
established under section 517A and (2) the interpretation of key
provisions of section 517A of the FD&C Act regarding supervisory
review. In addition, the proposed regulations would introduce new
procedural requirements for supervisory review within CDRH of other
CDRH decisions that were not addressed in FDASIA and the Cures Act.
    The proposed regulations will provide transparency and clarity for
internal and external stakeholders on CDRH's process for supervisory
review of decisions and will give requesters new predictability through
binding deadlines for FDA action on a request for supervisory review
within CDRH and the Center's internal agency review of ``significant
decisions.'' Furthermore, this proposal, when finalized, will codify
the types of decisions that are considered ``significant decisions,''
for which the timeframes apply. The proposed regulations will also
codify the timeframe for submission of requests for the review of other
decisions within CDRH.

B. Summary of the Major Provisions of the Proposed Rule

    FDA proposes to amend part 10 (21 CFR part 10) by adding Sec.
10.75(e). Section 10.75 currently provides that an interested person
outside the Agency may request internal agency review of a decision of
an FDA employee. FDA proposes to amend Sec.  10.75 to add paragraph
(e), which would require that requests for internal agency supervisory
review within CDRH of a decision also comply with proposed Sec.  800.75
(21 CFR 800.75). This proposed change to the regulations would
encompass both significant decisions under section 517A of the FD&C Act
and other decisions by CDRH employees.
    The proposed rule would also add new Sec.  800.75 to part 800 (21
CFR part 800). Proposed Sec.  800.75 would incorporate in the
regulations the provisions of section 517A of the FD&C Act for review
of ``significant decisions'' related to devices regulated under the
FD&C Act by CDRH. Proposed Sec.  800.75 would define ``significant
decisions.'' Section 800.75 would also include the timeframes for
submission of requests for internal agency review of significant
decisions within CDRH and for responses to such requests.
    Proposed Sec.  800.75 would further address requests for
supervisory review within CDRH of decisions other than section 517A
decisions and would indicate the timeframe for submission of these
requests for internal agency review.

C. Legal Authority

    FDA's legal authority to implement requirements pertaining to the
process and timelines for Sec.  10.75 appeals of decisions within CDRH
derives from sections 510(k), 515, 515C, 517A, and 520(g) of the FD&C
Act (21 U.S.C. 360(k), 360e, 360e-3, 360g-1, and 360j) and other
provisions under which a decision might be appealed, and 701(a) of the
FD&C Act (21 U.S.C. 371(a)). Section 701(a) of the FD&C Act gives FDA
general rulemaking authority to issue regulations for the efficient
enforcement of the FD&C Act.

D. Costs and Benefits

    We expect the costs and benefits of the proposed rule to be
negligible.

II. Background

A. Regulations on Internal Agency Review

    FDA has long provided a path for outside parties to request
internal agency review of decisions. A procedure for this type of
review was first published as a proposed regulation in 1975 (40 FR
40682, September 3, 1975) (Ref. 2). In the preamble for the proposed
rule, the Agency recognized that a process for administrative review of
Agency decisions would advise outside parties how they should pursue
matters that interest and concern them (40 FR 40682 at 40693). A final
rule published in 1977 incorporated these provisions into the Code of
Federal Regulations at 21 CFR 2.17 (42 FR 4680, January 25, 1977) (Ref.
3).
    These regulations provided that any decision of an FDA employee,
other than the Commissioner, on any matter was subject to review by the
employee's supervisor under any of the following circumstances: (1) At
the request of the employee, (2) on the initiative of the supervisor,
(3) at the request of any interested person outside of the Agency, or
(4) as required by duly promulgated delegations of authority. The
review shall be accomplished by consultation between the employee and
the supervisor, by review of the administrative file, or both. The
review shall ordinarily follow established Agency channels of
supervision. Internal agency review shall be based on the data and
information available in the administrative file. If an interested
person presents new data or information not contained in the
administrative file, then the matter shall be returned to the
appropriate lower level within the Agency for a reevaluation based upon
the new information (Sec.  2.17 (1977)).
    The following year, in 1978, a proposed rule was published to
reorganize and revise the Agency's administrative practices and
procedures regulations (43 FR 51966, November 7, 1978) (Ref. 4). When
the final rule for this action was published, the regulations for
internal agency review were moved from Sec.  2.17 and redesignated as
Sec.  10.75 (44 FR 22318, April 13, 1979) (Ref. 5), where these
regulations remain today.
    In 1998, Sec.  10.75 was amended to add provisions allowing a
sponsor, applicant, or manufacturer of a drug or device to request
review of a scientific controversy by an appropriate scientific
advisory panel or advisory committee (63 FR 63978, November 18, 1998).
Aside from the specific situation addressed by the amendment, the
elements of internal agency review under Sec.  10.75 relating to who
may request the review and the information on which the review must be
based remained unchanged.
    Section 10.75 contains regulations that establish an orderly
process for internal agency review of decisions, based on information
in the FDA administrative file. Section 10.75 applies to requests for
review of decisions made by any FDA employee, other than decisions by
the Commissioner of Food and Drugs. Section 10.75 does not establish
timelines for requests for Agency review or for the Agency to act upon
these requests. The FDA guidance document entitled ``Center for Devices
and Radiological Health Appeals Processes--Guidance for Industry and
Food and Drug Administration Staff'' describes the Sec.  10.75 appeal
processes available to outside stakeholders to request review of
decisions or actions by CDRH employees (Ref. 6).

B. Agency Documentation and Review of Significant Decisions Regarding
Devices Under Section 517A of the Federal Food, Drug, and Cosmetic Act

    On July 9, 2012, the FD&C Act (21 U.S.C. 301 et seq.) was amended
by FDASIA. Section 603 of FDASIA added new section 517A to the FD&C
Act, which specifies procedures and timeframes for the supervisory
review of significant decisions pertaining to devices regulated by
CDRH.
    On December 13, 2016, the FD&C Act (21. U.S.C. 301 et seq.) was
further amended by the Cures Act. Section 3051 of the Cures Act,
``Breakthrough Devices,'' added section 515C to the FD&C Act and
amended section 517A(a)(1) to include any significant decision by CDRH
regarding a request for designation as a breakthrough device under
section 515C.
    In addition, section 3058, ``Least Burdensome Device Review,'' of
the Cures Act amended section 517A(a) by adding subsection (3), which
requires that the substantive summary include a brief statement of how
the least burdensome requirements were considered and applied
consistent with sections 513(i)(1)(D), 513(a)(3)(D), and 515(c)(5) of
the FD&C Act, as applicable.
    Section 517A of the FD&C Act provides that any person may request a
supervisory review of any significant decision of CDRH regarding the
submission or review of a report under section 510(k), an application
under section 515, a request for designation under section 515C, or an
application for an exemption under section 520(g) of the FD&C Act. Any
person may request such review, which may be conducted at the next
supervisory level or higher above the individual who made the
significant decision. Where the request for supervisory review was made
at the organizational level, any person may request a supervisory
review to the next organizational level or higher above the level at
which the decision was made. In addition, the Office or Center Director
may designate a Deputy Director to be their representative as the
authority for a request made to that level. In this situation, a
request for review heard by a Deputy is rendered on behalf of the
Director and constitutes a review by that level of the organization
(Ref. 6).
    Section 517A of the FD&C Act includes specific timeframes both for
the person requesting review and for FDA to respond to such a request.
A request for review of a significant decision is required to be
submitted to FDA not later than 30 days after such decision. In
responding to this request, if the requester seeks an in-person meeting
or a teleconference review, FDA is required to schedule the requested
interaction not later than 30 days after the request is made. FDA is
required to issue a decision not later than 30 days after the
interaction, or, in the case of a person who does not seek an in-person
meeting or teleconference review, FDA is required to issue a decision
no later than 45 days after the request for supervisory review is
received by FDA. An exception to the timeframes related to scheduling
an in-person meeting or teleconference review, and to FDA's decision on
a request for supervisory review of the significant decision, is
provided in cases that are referred to experts outside of FDA. Although
the procedures and timeframes in section 517A of the FD&C Act apply to
an initial request for supervisory review of a significant decision by
CDRH, CDRH has chosen to enhance transparency and predictability and
apply those procedures and timeframes as well to sequential requests
for supervisory review of significant decisions that are submitted to
CDRH.

III. Legal Authority

    We are proposing to codify the procedures and timeframes in section
517A of the FD&C Act, added by section 603 of FDASIA and amended by the
Cures Act, for Sec.  10.75 appeals of ``significant decisions''
regarding the submission or review of a report under section 510(k), an
application under section 515, a request for designation under section
515C, or an application for an exemption under section 520(g) of the
FD&C Act.
    We are also proposing additional procedural requirements for Sec.
10.75 appeals submitted to CDRH of other types of CDRH decisions not
addressed in the FDASIA and the Cures Act.
    FDA's legal authority to implement requirements pertaining to the
process and timelines for Sec.  10.75 appeals submitted to CDRH derives
from sections 510(k), 515, 515C, 517A, and 520(g) of the FD&C Act and
other provisions under which a decision might be appealed, and 701(a)
of the FD&C Act. Section 701(a) of the FD&C Act gives FDA general
rulemaking authority to issue regulations for the efficient enforcement
of the FD&C Act.

IV. Description of the Proposed Rule

    The proposed rule would, if finalized, incorporate the procedures
and timeframes in section 517A to an initial or sequential request for
supervisory review within CDRH of ``significant decisions'' by CDRH
into FDA's regulations. The proposed regulations would also introduce
new procedural requirements for requests for supervisory review within
CDRH under Sec.  10.75 of decisions that do not fall under
``significant decisions'' under section 517A of the FD&C Act.
    FDA proposes to amend part 10 by adding Sec.  10.75(e). Section
10.75 currently provides that an interested person outside the Agency
may request internal agency review of a decision of an FDA employee.
FDA proposes to amend Sec.  10.75 to add paragraph (e), which would
require that requests for internal agency supervisory review within
CDRH also comply with proposed Sec.  800.75. This proposed change to
the regulations would encompass both significant decisions under
section 517A of the FD&C Act and other types of decisions.
    The proposed rule would add new Sec.  800.75 to part 800. Proposed
Sec.  800.75 would incorporate, into the regulations, the provisions of
section 517A of the FD&C Act for review of significant decisions
related to devices regulated under the FD&C Act by CDRH. Proposed Sec.
800.75 would define ``significant decisions.'' Section 800.75 would
also include the timeframes for submission of requests for internal
agency review of significant decisions within CDRH and for responses to
such requests.
    Proposed Sec.  800.75 would further address the review of decisions
other than 517A decisions and would indicate the timeframe for
submission of these requests for internal agency review within CDRH.

A. Proposed Revisions to Sec.  10.75

    Part 10 would be amended to add Sec.  10.75(e). FDA proposes to add
language to clarify that requests by interested persons outside the
Agency for internal agency review of a decision within CDRH must also
comply with proposed Sec.  800.75. Proposed Sec.  10.75(e) would not be
limited to significant decisions under section 517A of the FD&C Act.
Rather, proposed Sec.  10.75(e) would also encompass review of
decisions other than 517A decisions made by CDRH.

B. Proposed Sec.  800.75

    Section 517A of the FD&C Act establishes procedural requirements,
including timeframes for a request for internal agency review of a
``significant decision'' by CDRH. ``Significant decision'' is not
defined in the statutory provision. FDA is proposing to define
``significant decision,'' to provide greater clarity regarding which
decisions fall within this statutory term.
    A ``517A decision'' would be defined as a significant decision
regarding a device as set forth in section 517A of the

FD&C Act. We are proposing to use the term ``517A decision'' rather
than the term ``significant decision'' because we do not want to imply
that all other decisions of the Agency that do not fall within section
517A of the FD&C Act are not significant. Similarly, we did not want to
use the term ``non-significant decision'' when speaking of decisions
outside of the scope of section 517A, as that might imply some
unintended assessment on our part concerning the importance of these
types of decisions. In addition, because we are proposing these
regulations to include regulatory decisions by CDRH besides those set
forth in section 517A, we wanted to avoid any confusion that might
occur in distinguishing between these two categories of decisions. For
these reasons, we instead are proposing to use the term ``517A
decision'' for those decisions that are identified under section 517A
as significant decisions, and to refer to other decisions by CDRH as
``non-517A decisions.''
    The review procedures under section 517A of the FD&C Act apply only
to a request for review of a significant decision by CDRH regarding
submission or review of a report under section 510(k) (Premarket
Notification), an application under section 515 (Premarket Approval or
``PMA''/Humanitarian Device Exemption or ``HDE''), a request for
designation under section 515C (Breakthrough Devices), or an
application for an exemption under section 520(g) of the FD&C Act
(Investigational Device Exemption or ``IDE''). CDRH is proposing that
only the following decisions be considered significant decisions under
section 517A of the FD&C Act and, thus, defined for purposes of this
proposed rule as ``517A decisions'':
     510(k): Not substantially equivalent; Substantially
equivalent.
     PMA/HDE: Not approvable; Approvable; Approval; Denial.
     Breakthrough Devices: Expedited access pathway (Ref. 7)
program request for breakthrough designation for devices subject to
premarket notification, premarket approval, or de novo requests. Grant;
Denial of request for breakthrough designation.
     IDE: Disapproval; Approval.
     Failure to reach agreement on protocol under section
520(g)(7) of the FD&C Act.
     ``Clinical Hold'' determinations under section 520(g)(8)
of the FD&C Act.
    In proposing Sec.  800.75, we are mindful that outside parties may
use Sec.  10.75 to request review of decisions other than 517A
decisions. For this reason, we are also proposing new procedural
requirements for internal agency supervisory review within CDRH under
Sec.  10.75 of non-517A decisions made by CDRH employees. A request for
supervisory review of a CDRH decision other than a 517A decision is to
be received no later than 60 days after the date of the decision that
is subject to review. Any request received after 60 days in these cases
will be denied as untimely, unless CDRH, for good cause related to
circumstances beyond the control of the submitter, such as snow
emergency, Federal Government shutdown, or other unforeseen emergency
event, permits the request to be filed after 60 days.
    Section 800.75 proposes that requests for CDRH review of 517A
decisions and non-517A decisions must be addressed to the next
organizational level or higher above the individual who made the
decision. Requests to elevate the review of such decisions should
include a rationale. The decision to collapse two or more levels of
review or to elevate a review would solely be at CDRH's discretion. In
addition, requesters should have exhausted review through the
supervisory chain below the Center Director level prior to request for
review at the Center Director level.
    As provided in the FDA guidance, entitled ``eCopy Program for
Medical Device Submissions--Guidance for Industry and Food and Drug
Administration Staff'' (eCopy guidance), appeals to submission types
identified under section 745A(b) of the FD&C Act are subject to the
electronic format requirements. (Ref. 8). Therefore, 10.75 requests for
supervisory review of 517A decisions within CDRH, and certain decisions
other than 517A decisions, must be submitted in accordance with section
745A(b) and the standards established by the eCopy guidance, when
applicable. In addition, requests for breakthrough designation under
section 515C of the FD&C Act for devices under sections 510(k),
513(f)(2), and 515(c) of the FD&C Act would be considered
``presubmissions'' to those submission types as identified under
section 745A, and, therefore, requests for breakthrough designation
would be subject to section 745A(b), and likewise, Sec.  10.75 requests
for review within CDRH.
    Further, Sec.  800.75 proposes that requests for supervisory review
of CDRH decisions other than 517A decisions must be sent to the CDRH
Ombudsman, and those decisions, other than 517A decisions not subject
to section 745A, are to be submitted in electronic format. Further
instructions will be provided regarding submission of such requests in
electronic format.

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective 90 days after the date of publication of a final rule in the
Federal Register or at a later date if stated in the final rule.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O. 12866 and 13563 direct us to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
proposed rule is not a significant regulatory action as defined by E.O.
12866. It has been determined that this proposed rule is an action that
does not impost more than de minimis costs.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we anticipate that the costs of the rule would be de
minimis, we propose to certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount. We have developed a comprehensive Economic Analysis of Impacts
that assesses the impacts of the proposed rule.
    The proposed rule would (1) define ``517A decision,'' (2) apply to
requests submitted to CDRH for review of 517A

decisions and decisions other than 517A decisions made by CDRH, and (3)
establish timelines and procedures for an interested person to request
supervisory review of these decisions by CDRH. By setting specific
timelines for persons to submit requests for supervisory review, the
proposed rule would help clarify the supervisory review process and
provide firms with an incentive to promptly submit review requests. The
proposed rule would also establish timelines for CDRH review of 517A
decisions, reducing uncertainty about when interested persons would
know the outcome of their requests for supervisory review. Because the
proposed rule would not change the effort needed to prepare and submit
a request for supervisory review, we anticipate that affected
interested persons would incur only negligible costs to read and learn
about the provisions of the proposed rule. We do not expect additional
costs for FDA.
    We received 42 requests for review in 2013, 28 requests for review
in 2014, 20 requests for review in 2015, and 20 requests for review in
2016. We estimate that each request for review required 70 hours of
CDRH staff time. One possible benefit of the proposed rule, if
finalized, is that it may reduce the number of hours required per
request for review. If firms have more clarity about the request for
review process, they may not have to spend as much time navigating the
process, and we may not need to spend as much time guiding them through
the process.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information regarding the appeals process for devices in
the guidance document entitled ``Center for Devices and Radiological
Health Appeals Processes'' have been approved under OMB control number
0910-0738; the collections of information in 21 CFR part 807, subpart E
(premarket notification) have been approved under OMB control number
0910-0120; the collections of information for De Novo classification
requests have been approved under the OMB control number 0910-0844; the
collections of information in 21 CFR part 812 (investigational device
exemption) have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 814 (premarket approval) have
been approved under OMB control number 0910-0231; and the collections
of information in 21 CFR part 814, subpart H (humanitarian use devices)
have been approved under OMB control number 0910-0332.

IX. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule does not contain policies that would have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the proposed rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

X. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. ``Center for Devices and Radiological Health Appeals Processes:
Questions and Answers About 517A--Guidance for Industry and Food and
Drug Administration Staff,'' July 30, 2014, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM352254.pdf.
2. 40 FR 40682, September 3, 1975 http://heinonline.org/HOL/PDFsearchable?handle=hein.fedreg/040171&collection=fedreg§ion=0&id=179&print=1§ioncount=1&ext=.pdf&nocover=.
3. 42 FR 4680, January 25, 1977 http://heinonline.org/HOL/PDFsearchable?handle=hein.fedreg/042016&collection=fedreg§ion=0&id=250&print=1§ioncount=1&ext=.pdf&nocover=.
4. 43 FR 51966, November 7, 1978 http://heinonline.org/HOL/PrintRequest?collection=fedreg&nocover=&handle=hein.fedreg%2F043216&id=186§ion=&skipstep=1&fromid=186&toid=238&format=PDFsearchable&submitx=Print%2FDownload&submit1=Print%2FDownload+Custom+Range.
5. 44 FR 22318, April 13, 1979 http://heinonline.org/HOL/PrintRequest?collection=fedreg&nocover=&handle=hein.fedreg%2F044073&id=258§ion=&skipstep=1&fromid=258&toid=376&format=PDFsearchable&submitx=Print%2FDownload&submit1=Print%2FDownload+Custom+Range.
6. ``Center for Devices and Radiological Health Appeals Processes--
Guidance for Industry and Food and Drug Administration Staff,'' May
17, 2013, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf.
7. ``Expedited Access for Premarket Approval and De Novo Medical
Devices Intended for Unmet Medical Need for Life Threatening or
Irreversibly Debilitating Diseases or Conditions--Guidance for
Industry and Food and Drug Administration Staff,'' April 13, 2015,
available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393978.pdf.
8. ``eCopy Program for Medical Device Submissions--Guidance for
Industry and Food and Drug Administration Staff,'' December 3, 2015,
available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf.

List of Subjects

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 10 and 800 be amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.

0
2. In Sec.  10.75, add paragraph (e) to read as follows:

Sec.  10.75   Internal agency review of decisions.

* * * * *
    (e) Each request by an interested person for review of a decision
within the Center for Devices and Radiological Health shall also comply
with Sec.  800.75 of this chapter.

PART 800--GENERAL

0
3. The authority citation for part 800 is revised to read as follows:

    Authority:  5 U.S.C. 551-559; 21 U.S.C. 301-399f.

0
4. In part 800, add Sec.  800.75 to subpart C to read as follows:

Sec.  800.75   Requests for supervisory review of certain decisions
made by the Center for Devices and Radiological Health.

    (a) The following definitions shall apply to this section:
    (1) FDA means the Food and Drug Administration.
    (2) 517A decision means a significant decision made by the Center
for Devices and Radiological Health, as set forth in section 517A of
the Federal Food, Drug, and Cosmetic Act, and includes one of the
following decisions:
    (i) A substantially equivalent order under Sec.  807.100(a)(1) of
this chapter, or a not substantially equivalent order under Sec.
807.100(a)(2) of this chapter;
    (ii) An approval order under Sec.  814.44(d) of this chapter, an
approvable letter under Sec.  814.44(e) of this chapter, a not
approvable letter under Sec.  814.44(f) of this chapter, or an order
denying approval under Sec.  814.45 of this chapter;
    (iii) An approval order under Sec.  814.116(b) of this chapter, an
approvable letter under Sec.  814.116(c) of this chapter, a not
approvable letter under Sec.  814.116(d) of this chapter, or an order
denying approval under Sec.  814.118 of this chapter;
    (iv) A grant or denial of a request for breakthrough device
designation under section 515C of the Federal Food, Drug, and Cosmetic
Act;
    (v) An approval order under Sec.  812.30(a) of this chapter or a
disapproval order under Sec.  812.30(c) of this chapter;
    (vi) A failure to reach agreement letter under section 520(g)(7) of
the Federal Food, Drug, and Cosmetic Act; or
    (vii) A clinical hold determination under section 520(g)(8) of the
Federal Food, Drug, and Cosmetic Act.
    (3) CDRH means the Center for Devices and Radiological Health.
    (b) Submission of request.
    (1) Review of 517A decisions.
    (i) An initial or sequential request for supervisory review within
CDRH of a 517A decision under Sec.  10.75 of this chapter must be
addressed to the next organizational level or higher above the
individual who made the decision; submitted in electronic format in
accordance with section 745A(b) of the Federal Food, Drug, and Cosmetic
Act; marked ``Appeal: Request for Supervisory Review;'' and received by
CDRH no later than 30 days after the date of the decision involved. Any
such request for supervisory review not received by CDRH within 30 days
after the date of the decision involved is not eligible for review.
Except as provided in paragraph (b)(1)(ii) or (iii) of this section,
FDA will render a decision within 45 days of the request for
supervisory review.
    (ii) A person requesting supervisory review under paragraph
(b)(1)(i) may request an in-person meeting or teleconference with the
supervisor reviewing the request for supervisory review. Except as
provided in paragraph (b)(1)(iii) of this section, if a request for in-
person meeting or teleconference is included in the request for
supervisory review to CDRH, CDRH will schedule the meeting or
teleconference to occur within 30 days of receipt of the request.
Except as provided in paragraph (b)(1)(iii) of this section, a decision
will be rendered within 30 days of such meeting or teleconference.
    (iii) The timeframes for CDRH to render a decision provided in
(b)(1)(i) and (ii), and the timeframe to schedule an in-person meeting
or teleconference review in (b)(1)(ii) of this section do not apply, if
a matter related to the 517A decision under review is referred by CDRH
to external experts, such as an advisory committee, as provided in
Sec.  10.75(b) of this chapter.
    (2) An initial or sequential request for supervisory review within
CDRH under Sec.  10.75 of this chapter of a decision other than a 517A
decision that is not received by CDRH within 60 days after the date of
the decision involved will be denied as untimely, unless CDRH, for good
cause, permits the request to be filed after 60 days. An initial or
sequential request for supervisory review within CDRH of a decision
other than a 517A decision must be addressed to the next organizational
level or higher above the individual who made the decision; submitted
in electronic format in accordance with section 745A(b) of the Federal
Food, Drug, and Cosmetic Act, when applicable; marked, ``Appeal:
Request for Supervisory Review'' in the subject line of the electronic
request; and sent to the CDRH Ombudsman at [email protected].

    Dated: January 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00646 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Rules and Regulations]
[Pages 5367-5369]
[FR Doc No: 2016-01747]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-2068; Directorate Identifier 2016-SW-002-AD;
Amendment 39-18387; AD 2016-02-06]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Bell
Helicopter Textron Canada Limited (Bell) Model 429 helicopters. This AD
requires inspecting each tail rotor (T/R) pitch link (link) bearing
bore for corrosion and pitting and either replacing the T/R link or
applying sealant. This AD also requires a recurring inspection of the
sealant and repeating the inspections for corrosion and pitting if any
sealant is missing. This AD is prompted by an incident in which a
helicopter experienced an in-flight failure of a T/R link. These
actions are intended to detect corrosion or pitting and to prevent
failure of a T/R link and subsequent loss of control of the helicopter.

DATES: This AD becomes effective February 2, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of February 2,
2016.
    We must receive comments on this AD by April 4, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
2068; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the Transport Canada AD, the incorporated by
reference service information, the economic evaluation, any comments
received, and other information. The street address for the Docket
Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.
    For service information identified in this final rule, contact Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at http://www.bellcustomer.com/files/. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    We are adopting a new AD for Bell Model 429 helicopters with a T/R
link part number (P/N) 429-012-112-101, -101FM, -103, or -103FM
installed. This AD requires inspecting each T/R link bearing bore for
any aluminum oxide corrosion and then cleaning the affected area of the
T/R link and inspecting for any pitting. If there is any corrosion or
any pitting, this AD requires replacing the T/R link. If there is no
corrosion or pitting, this AD requires applying corrosion preventative
sealant. This AD also requires a recurring inspection of the sealant,
and repeating the inspection for corrosion and pitting if any sealant
is missing.
    This AD was prompted by AD No. CF-2016-01, dated January 5, 2016,
issued by Transport Canada, which is the aviation authority for Canada,
to correct an unsafe condition for Bell Model 429 helicopters.
Transport Canada advises of an incident in which a T/R link on a Model
429 helicopter failed, causing vibration and difficulty controlling the
helicopter. According to Transport Canada, the failure was caused by a
crack that had initiated at a corrosion pit between the roll staked lip
of the bearing and the beveled edge of the link. Transport Canada
further states deficiencies in the application of corrosion resistant
finishes to the link during manufacturing caused the corrosion.
    This condition, if not detected, could result in failure of a link
and loss of control of the helicopter. For these reasons, Transport
Canada AD No. CF-2016-01 requires inspection of the T/R link and
replacement of any link with corrosion. The Transport Canada AD also
requires application of corrosion preventative sealant and re-
identification of the T/R link.

FAA's Determination

    This helicopter has been approved by the aviation authority of
Canada and is approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, Transport Canada, its technical
representative, has notified us of the unsafe condition described in
the Canadian AD. We are issuing this AD because we evaluated all
information provided by Transport Canada and determined the unsafe
condition exists and is likely to exist or

develop on other helicopters of the same type design.

Related Service Information Under 1 CFR Part 51

    Bell Helicopter issued Alert Service Bulletin 429-15-26, dated
December 7, 2015 (ASB), which advises of receiving reports of corrosion
on T/R links between the roll staked lip of bearing P/N 429-312-107-103
and the beveled edge of T/R link P/N 429-012-112-101/-103. The ASB
specifies, within 10 flight hours or before March 7, 2016, an
inspection with 10X magnification of all 8 T/R link bearing bores
between the roll staked lip of the bearing outer race and the link
bearing bore for corrosion. If there is corrosion, the ASB specifies
replacing the link. If there is no corrosion, the ASB specifies
cleaning the area and performing a second inspection with 10X
magnification. If there is corrosion, the ASB specifies replacing the
link. If there is no corrosion, the ASB specifies removing the torque
stripe, cleaning the area, and applying corrosion preventative sealant.
The ASB also specifies re-identifying the P/Ns as 429-012-112-101FM and
429-012-112-103FM. Further, the ASB specifies, at intervals of 50
flight hours after the initial actions, an inspection of the sealant
and reapplication if the sealant is damaged.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD requires, within 10 hours time-in-service (TIS), without
first cleaning the T/R link bearing bores, using 10X or higher
magnification to inspect each T/R link bearing bore for any aluminum
oxide corrosion extruding from between the roll staked lip of the
bearing outer race and the link bearing bore. If there is any aluminum
oxide corrosion, this AD requires replacing the T/R link before further
flight. If there is no corrosion, this AD requires cleaning the T/R
link bearing bores and inspecting for any pitting. If there is any
pitting, this AD requires replacing the T/R link before further flight.
If there is no pitting, this AD requires applying corrosion
preventative sealant. Within 50 hours TIS and thereafter at intervals
not to exceed 50 hours TIS, this AD requires inspecting the corrosion
preventative sealant of each T/R link by using 10X or higher
magnification. If the corrosion preventative sealant is missing, this
AD requires performing the inspections for any aluminum oxide corrosion
and pitting.

Differences Between This AD and the Transport Canada AD

    This AD only applies to helicopters with certain link P/Ns
installed. The Transport Canada AD does not specify link P/Ns. This AD
requires inspecting the bearing bores for any pitting after cleaning
the T/R link, while the Transport Canada AD requires inspecting for
corrosion after cleaning the T/R link. This AD requires inspecting the
sealant with 10X or higher magnification, while the Transport Canada AD
does not specify any magnification. This AD does not require re-
identifying the P/N of the link, whereas the Transport Canada AD does.
As part of the recurring inspection of the corrosion preventative
sealant, if the sealant is missing, this AD requires repeating the
inspections for aluminum oxide corrosion and pitting to ensure part
integrity before reapplying sealant. The Transport Canada AD only
specifies reapplying sealant if the sealant is damaged.

Costs of Compliance

    We estimate that this AD affects 73 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to
comply with this AD. We estimate the cost of labor at $85 per work-
hour.
    Inspecting the set of T/R links (eight bearings) for corrosion will
take about one work-hour for an estimated cost of $85 per helicopter
and $6,205 for the U.S. fleet. Cleaning and inspecting the set of T/R
links for pitting will take about one work-hour for an estimated cost
of $85 per helicopter. Replacing a T/R link will require no additional
work-hours after inspection and required parts cost $2,739 for an
estimated replacement cost of $2,739 per T/R link. Removing the torque
stripe, cleaning, and applying sealant to the set of T/R links will
take about one work-hour with a negligible parts cost for an estimated
cost of $85 per helicopter. Inspecting the sealant on a set of T/R
links will take about one work-hour for an estimated cost of $85 per
helicopter and $6,205 for the U.S. fleet per inspection cycle.
    According to Bell Helicopter's service information some of the
costs of this AD may be covered under warranty, thereby reducing the
cost impact on affected individuals. We do not control warranty
coverage by Bell Helicopter. Accordingly, we have included all costs in
our cost estimate.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because the unsafe condition can
adversely affect control of the helicopter, and certain required
corrective actions must be accomplished within 10 hours TIS.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and contrary to
the public interest and that good cause exists for making this
amendment effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2016-02-06 Bell Helicopter Textron Canada Limited: Amendment 39-
18387; Docket No. FAA-2016-2068; Directorate Identifier 2016-SW-002-
AD.

(a) Applicability

    This AD applies to Bell Helicopter Textron Canada Limited Model
429 helicopters with a tail rotor (T/R) pitch link (link) part
number (P/N) 429-012-112-101, -101FM, -103, or -103FM installed,
certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of a T/R link.
This condition could result in loss of T/R flight control and
subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective February 2, 2016.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) For T/R link P/N 429-012-112-101 and 429-012-112-103, within
10 hours time-in-service (TIS):
    (i) Remove each T/R link assembly. Prior to cleaning the T/R
link bearing bores, using 10X or higher power magnification, inspect
each T/R link bearing bore for aluminum oxide corrosion extruding
from between the roll staked lip of the bearing outer race and the
link bearing bore. Aluminum oxide corrosion appears as a white
crystalline material in contrast with the black finish and any
accumulated soot. An example of this corrosion is shown in Figure 1
of Bell Helicopter Alert Service Bulletin 429-15-26, dated December
7, 2015 (ASB 429-15-26).
    (ii) If there is any aluminum oxide corrosion, replace the T/R
link before further flight.
    (iii) If there is no aluminum oxide corrosion, clean each T/R
link bearing bore with isopropyl alcohol and inspect for pitting.
    (A) If there is any pitting, replace the T/R link before further
flight.
    (B) If there is no pitting, apply corrosion preventative sealant
by following the Accomplishment Instructions, paragraph 5. of Part
I, of ASB 429-15-26.
    (2) For all T/R links listed in paragraph (a) of this AD, within
50 hours TIS and thereafter at intervals not to exceed 50 hours TIS,
using 10X or higher power magnification, inspect each T/R link
bearing bore for missing corrosion preventative sealant. If any
corrosion preventative sealant is missing, perform the actions in
paragraph (e)(1)(i) through (e)(1)(iii) of this AD before further
flight.
    (3) Do not install T/R link P/N 429-012-112-101 or -103 on any
helicopter before complying with the actions in paragraph (e)(1) of
this AD.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Fuller, Senior Aviation
Safety Engineer, Safety Management Group, Rotorcraft Directorate,
FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in Transport Canada AD CF-
2016-01, dated January 5, 2016. You may view the Transport Canada AD
on the Internet at http://www.regulations.gov by searching for and
locating it in Docket No. FAA-2016-2068.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6400, Tail Rotor
System.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Bell Helicopter Alert Service Bulletin 429-15-26, dated
December 7, 2015.
    (ii) Reserved.
    (3) For Bell Helicopter service information identified in this
final rule, contact Bell Helicopter Textron Canada Limited, 12,800
Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or
(800) 363-8023; fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on January 22, 2016.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2016-01747 Filed 2-1-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]
[Page 11545-11549]
[DOCID:fr11mr10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0101]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Form FDA 3356;
Eligibility Determination for Donors; and Current Good Tissue Practice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

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 the information collection
requirements for FDA regulations related to human cells, tissues, and
cellular and tissue-based products (HCT[sol]Ps) involving establishment
registration and listing using Form FDA 3356; eligibility determination
for donors; and current good tissue practice (CGTP).

DATES:  Submit written or electronic comments on the collection of
information by May 10, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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.

Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Form FDA 3356; Eligibility
Determination for Donors; and Current Good Tissue Practice--(OMB
Control Number 0910-0543)--Extension

    Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign countries
into the States. As derivatives of the human body, all HCT[sol]Ps pose
some risk of carrying pathogens that could potentially infect
recipients or handlers. FDA has issued regulations related to
HCT[sol]Ps involving establishment registration and listing using Form
FDA 3356, eligibility determination for donors, and CGTP.

A. Establishment Registration and Listing; Form FDA 3356

    The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT[sol]P described in Sec.  1271.10(a), or
that perform screening or testing of the cell or tissue donor to
register with FDA (Sec.  1271.10(b)(1)) and submit a list of each
HCT[sol]P manufactured (Sec.  1271.10(b)). Section 1271.21(a) requires
an establishment to follow certain procedures for initial registration
and listing of HCT[sol]Ps, and Sec.  1271.25(a) and (b) identifies the
required initial registration and HCT[sol]P listing information.
Section 1271.21(b), in brief, requires an annual update of the
establishment registration. Section 1271.21(c)(ii) requires
establishments to submit HCT[sol]P listing updates when an HCT[sol]P is
changed as described in Sec.  1271.25(c). Section 1271.25(c) identifies
the required HCT[sol]P listing update information. Section 1271.26
requires establishments to submit an amendment if ownership or location
of the establishment changes. FDA requires the use of a registration
and listing form (Form FDA 3356: Establishment Registration and Listing
for Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT[sol]Ps)) to submit the required information (Sec. Sec.  1271.10,
1271.21, 1271.25, and 1271.26). To further facilitate the ease and
speed of submissions, electronic submission is accepted (http://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/
TissueEstablishmentRegistration/default.htm).

B. Eligibility Determination for Donors

    In brief, FDA requires certain HCT[sol]P establishments described
in Sec.  1271.1(b) to determine donor eligibility based on donor
screening and testing for relevant communicable diseases agents and
diseases, except as provided under Sec.  1271.90. The documented
determination of a donor's eligibility is made by a responsible person
defined in Sec.  1271.3(t) and is based on the results of required
donor screening, which includes a donor medical history interview
(defined in Sec.  1271.3(n)) and testing (Sec.  1271.50(a)). Certain
records must accompany an HCT[sol]P once the donor-eligibility
determination has been made (Sec.  1271.55(a)). This requirement
applies both to an HCT[sol]P from a donor who is determined to be
eligible as well as to an HCT[sol]P from a donor who is determined to
be ineligible or where the donor-eligibility determination is not
complete if there is a documented urgent medical need (Sec.  1271.60).
Once the donor-eligibility determination has been made, the HCT[sol]P
must be accompanied by a summary of records used to make the donor-
eligibility determination (Sec.  1271.55(b)) and a statement whether,
based on the results of the screening and testing, the donor is
determined to be eligible or ineligible (Sec.  1271.55(a)(2)).
    Records used in determining the eligibility of a donor, i.e.,
results and interpretations of testing for relevant communicable
disease agents, the donor-eligibility determination, the name and
address of the testing laboratory or laboratories, and the name of the
responsible person (defined in Sec.  1271.3(t)) who made the donor-
eligibility determination and the date of the determination, must be
maintained (Sec.  1271.55(d)(1)). If any information on the donor is
not in English, the original record must be retained and translated to
English and accompanied by a statement of authenticity from the
translator (Sec.  1271.55(d)(2)). HCT[sol]P establishments must retain
the records pertaining to HCT[sol]Ps at least 10 years after the date
of administration, distribution, disposition, or expiration, whichever
is latest (Sec.  1271.55(d)(4)).
    When a product is shipped in quarantine as defined in Sec.
1271.3(q), before completion of screening and testing, the HCT[sol]P
must be accompanied by records identifying the donor; stating that the
donor-eligibility determination has not been completed; and stating
that the product must not be used until the donor-eligibility
determination has been completed (Sec.  1271.60(c)). When an HCT[sol]P
is used in cases of documented urgent medical need, the results of any
completed donor screening and testing, and a list of any required
screening and testing not yet completed also must accompany the
HCT[sol]P (Sec.  1271.60(d)(2)). When an HCT[sol]P is used in cases of
urgent medical need or from a donor who has been determined to be
ineligible (as permitted under Sec.  1271.65), documentation by the
HCT[sol]P establishment is required showing that the recipient's
physician received notification that the testing and screening were not
complete (in cases of urgent medical need), and upon the completion of
the donor-eligibility determination, of the results of the
determination (Sec.  1271.60(d)(3) and (d)(4) and Sec.  1271.65(b)(3)).
    An HCT[sol]P establishment is also required to establish and
maintain procedures for all steps that are performed in determining
eligibility (Sec.  1271.47(a)), including the use of a product from a
donor testing reactive for cytomegalovirus (Sec.  1271.85(b)(2)). The
HCT[sol]P establishment must record any departure from the procedures
(Sec.  1271.47(d)).

C. Current Good Tissue Practice (CGTP)

    FDA requires certain HCT[sol]P establishments to follow CGTP

(Sec.  1271.1(b)). Section 1271.155(a) permits the submission of a
request for FDA approval of an exemption from or alternative to any
requirement in subpart C or D of part 1271. Section 1271.290(c)
requires such establishments to affix a distinct identification code to
each HCT[sol]P that it manufactures that relates the HCT[sol]P to the
donor and to all records pertaining to the HCT[sol]P. Whenever an
establishment distributes an HCT[sol]P to a consignee, Sec.
1271.290(f) requires the establishment to inform the consignee, in
writing, of the product tracking requirements and the methods the
establishment uses to fulfill the requirements. Non-reproductive
HCT[sol]P establishments described in Sec.  1271.10 are required under
Sec. Sec.  1271.350(a)(1) and (a)(3) to investigate and report to FDA
adverse reactions (defined in Sec.  1271.3(y)) using Form FDA-3500A
(Sec.  1271.350(a)(2)). Form FDA-3500A is approved under OMB Control
No. 0910-0291. Section 1271.370(b) and (c) requires establishments to
include specific information either on the HCT[sol]P label or with the
HCT[sol]P.
    The standard operating procedures (SOP) provisions under part 1271
include the following: (1) Section 1271.160(b)(2) (receiving,
investigation, evaluating, and documenting information relating to core
CGTP requirements, including complaints, and for sharing information
with consignees and other establishments); (2) Sec.  1271.180(a) (to
meet core CGTP requirements for all steps performed in the manufacture
of HCT[sol]Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of
equipment); (6) Sec.  1271.230(a) and (c) (validation of changes to a
process); (7) Sec.  1271.250(a) (controls for labeling HCT[sol]Ps); (8)
Sec.  1271.265(e) (receipt, predistribution shipment, availability for
distribution, and packaging and shipping of HCT[sol]Ps); (9) Sec.
1271.265(f) (suitable for return to inventory); (10) Sec.  1271.270(b)
(records management system); (11) Sec.  1271.290(b)(1) (system of
HCT[sol]P tracking); and (12) Sec.  1271.320(a) (review, evaluation,
and documentation of complaints (as defined in Sec.  1271.3(aa))).
    Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of the
terms and date of FDA approval. Section 1271.160(b)(3) requires
documentation of appropriate corrective actions taken as a result of an
audit of the quality program. Section 1271.160(b)(6) requires
documentation of HCT[sol]P deviations. Section 1271.160(d) requires
documentation of computer validation or verification activities and
results when computers are used to comply with the core CGTP
requirements for its intended use. Section 1271.190(d)(2) requires
documentation of all facility cleaning and sanitation activities
performed to prevent contamination of HCT[sol]Ps. Section 1271.195(d)
requires documentation of environmental control and monitoring
activities. Section 1271.200(e) requires documentation of equipment
maintenance, cleaning, sanitizing, calibration, and other activities.
Section 1271.210(d) requires documentation of the receipt,
verification, and use of each supply or reagent. Section 1271.230(a)
requires documentation of validation activities when the results of a
process cannot be fully verified by subsequent inspection and tests.
Section 1271.230(c) requires documentation of the review and evaluation
of a process and revalidation of the process, if necessary, when any
changes to a validated process occur. Section 1271.260(d) and (e)
requires documentation of any corrective action taken when proper
storage conditions are not met and documentation of storage
temperatures for HCT[sol]Ps. Section 1271.265(c)(1) requires
documentation that release criteria have been met before distribution
of an HCT[sol]P. Section 1271.265(c)(3) requires documentation of any
departure from a procedure at the time of its occurrence. Section
1271.265(e) requires documentation of the receipt, predistribution
shipment, distribution, and packaging and shipping of HCT[sol]Ps.
Section 1271.270(a) requires documentation of each step in
manufacturing required in part 1271, subparts C and D. Section
1271.270(e) requires documentation of the name and address, and a list
of responsibilities of any establishment that performs a manufacturing
step for an establishment. Sections 1271.290(d) and (e) require
documentation of a method for recording the distinct identification
code and type of each HCT[sol]P distributed to a consignee to enable
tracking from the consignee to the donor and to enable tracking from
the donor to the consignee or final disposition. Section 1271.320(b)
requires an establishment to maintain a record of each complaint that
it receives, that contains relevant information for proper review and
evaluation.
    Respondents to this information collection are establishments that
recover, process, store, label, package, or distribute any HCT[sol]P,
or perform donor screening or testing. The estimates provided below are
based on the most recent available information from FDA's database
system and trade organizations. The hours per response and hours per
record are based on data provided by the Eastern Research Group, or FDA
experience with similar recordkeeping or reporting requirements.
    There are an estimated 2,281 HCT[sol]P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 692
manufacturers of HCT[sol]P products regulated under the Federal Food,
Drug, and Cosmetics Act and section 351 of the PHS Act (42 U.S.C. 262),
that have registered and listed with FDA. In addition, we estimate that
251 new establishments have registered with FDA (Sec.  1271.10(b)(1)
and (b)(2) and Sec.  1271.25(a) and (b)). There are an estimated 2,230
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 565 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,167,396 HCT[sol]Ps
(which include conventional tissues, eye tissues, hematopoetic stem
cells/progenitor cells, and reproductive cells and tissues) and an
estimated total of 2,026,024 non-reproductive cells and tissues (total
HCT[sol]Ps minus reproductive cells and tissues) are distributed per
year by an estimated 1,589 establishments (2,281 - 692 = 1,589
establishments with approved applications).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375
establishments shipped an estimated 286,000 HCT[sol]Ps under
quarantine, and that an estimated 18 establishments requested an
exemption from or alternative to any requirement under part 1271,
subpart C or D, specifically under Sec.  1271.155(a).
    Under Sec.  1271.290(c) and Sec.  1271.370(b) and (c), an estimated
1,694 non-reproductive HCT[sol]P establishments label each of their
2,026,024 HCT[sol]Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
    FDA estimates 38 HCT[sol]P establishments submitted 76 adverse
reaction reports involving a communicable disease (Sec.
1271.350(a)(1)).
    FDA estimates that 251 new establishments will create SOPs, and
that 2,281 establishments will review and revise existing SOPs
annually.
    FDA estimates that 1,141 HCT[sol]P establishments (2,281 x 50% =
1,141)

and 847 non-reproductive HCT[sol]P establishments (1,694 x 50% = 847)
record and justify a departure from the procedures (Sec. Sec.
1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT[sol]P establishments are required to
have a documented medical history interview about the donor's medical
history and relevant social behavior as part of the donor's relevant
medical records for each of the estimated total of 91,240 donors (which
include conventional tissue donors, eye tissue donors, peripheral and
cord blood stem cell donors, and reproductive cell and tissue donors),
and the estimated total of 86,394 non-reproductive cells and tissue
donors (total donors minus reproductive cell and tissue donors).
    FDA estimates that 684 HCT[sol]P establishments (2,281 x 30% = 684)
document an urgent medical need for an HCT[sol]P and notify the
physician using the HCT[sol]P (Sec.  1271.60(d)(3) and (d)(4) and Sec.
1271.65(b)(3)(iii)).
    FDA also estimates that 1,824 HCT[sol]P establishments (2,281 x 80%
= 1,824) have to maintain records for an average of 2 contract
establishments that perform a manufacturing process step for them
(Sec.  1271.270(e)) and 1,141 HCT[sol]P establishments maintain an
average of 5 complaint records annually (Sec.  1271.320(b)).
    In some cases, the estimated burden may appear to be lower or
higher than the burden experienced by individual establishments. The
estimated burden in these charts is an estimated average burden, taking
into account the range of impact each regulation may have.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b)\2\                                     2,281                     1              2,281               .5                1,141
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and (b)(2), 1271.21(a), and 1271.25(a)                  251                     1                251               .75                 188
 and (b)\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(2), 1271.21(c)(2)(ii), and 1271.25(c)\2\                 2,230                     1              2,230               .5                1,115
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.26\2\                                                            565                     1                565               .25                 141
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a)                                                          1,589                 1,364          2,167,396               .5            1,083,698
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.60(c) and (d)(2)                                               1,375                   208            286,000               .5              143,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.155(a)                                                            18                     1                 18              3                     54
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.290(c)                                                         1,694                 1,196          2,026,024               .083            168,835
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.290(f)                                                         1,694                     1              1,694              1                  1,694
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.350(a)(1) and (a)(3)                                              38                     2                 76              1                     76
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.370(b) and (c)                                                 1,694                 1,196          2,026,024               .25             506,506
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                1,906,448
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
New SOPs\2\                                                           251                     1                251             48                 12,048
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOP Update\2\                                                       2,281                     1              2,281             24                 54,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.47(d)                                                          1,141                     1              1,141              1                  1,141
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.50(a)                                                          2,281                    40             91,240              5                456,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(d)(1)                                                       2,281                    40             91,240              1                 91,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(d)(2)                                                       2,281                     1              2,281              1                  2,281
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(d)(4)                                                       2,281                     1              2,281            120                273,720
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.60(d)(3) and (d)(4), and 1271.65(b)(3)(iii)                      684                     1                684              2                  1,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.155(f)                                                            18                     1                 18               .25                   5
--------------------------------------------------------------------------------------------------------------------------------------------------------

1271.160(b)(3) and (b)(6)                                           1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.160(d)                                                         1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.190(d)(2)                                                      1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.195(d)                                                         1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.200(e)                                                         1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.210(d)                                                         1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.230(a)                                                         1,694                    12             20,328              1                 20,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.230(c)                                                         1,694                     1              1,694              1                  1,694
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.260(d)                                                         1,694                    12             20,328               .25               5,082
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.260(e)                                                         1,694                   365            618,310               .083             51,526
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.265(c)(1)                                                      1,694                 1,196          2,026,024               .083            168,835
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.265(c)(3)                                                        847                     1                847              1                    847
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.265(e)                                                         1,694                 1,196          2,026,024               .083            168,835
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.270(a)                                                         1,694                 1,196          2,026,024               .25             506,506
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.270(e)                                                         1,824                     2              3,648               .5                1,824
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.290(d) and (e)                                                 1,694                    51             86,394               .25              21,599
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.320(b)                                                         1,141                     5              5,705              1                  5,705
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                1,967,496
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 1271.250(a), and
  1271.265(e).

    Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5229 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S