TITLE 15 - US CODE - COMMERCE AND TRADE - CHAPTER 53 - TOXIC SUBSTANCES
CONTROL - SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

15 USC 2613 – Disclosure of data

(a) In general

Except as provided by subsection (b) of this section, any information
reported to, or otherwise obtained by, the Administrator (or any
representative of the Administrator) under this chapter, which is exempt
from disclosure pursuant to subsection (a) of section 552 of title 5 by
reason of subsection (b)(4) of such section, shall, notwithstanding the
provisions of any other section of this chapter, not be disclosed by the
Administrator or by any officer or employee of the United States, except
that such information

(1) shall be disclosed to any officer or employee of the United States

(A) in connection with the official duties of such officer or employee
under any law for the protection of health or the environment, or

(B) for specific law enforcement purposes;

(2) shall be disclosed to contractors with the United States and
employees of such contractors if in the opinion of the Administrator
such disclosure is necessary for the satisfactory performance by the
contractor of a contract with the United States entered into on or after
October 11, 1976, for the performance of work in connection with this
chapter and under such conditions as the Administrator may specify;

(3) shall be disclosed if the Administrator determines it necessary to
protect health or the environment against an unreasonable risk of injury
to health or the environment; or

(4) may be disclosed when relevant in any proceeding under this
chapter, except that disclosure in such a proceeding shall be made in
such manner as to preserve confidentiality to the extent practicable
without impairing the proceeding.

In any proceeding under section   HYPERLINK
"http://openjurist.org/5/usc/552"  552    HYPERLINK
"http://openjurist.org/5/usc/552" \l "a"  (a)  of title   HYPERLINK
"http://openjurist.org/5/usc"  5  to obtain information the disclosure
of which has been denied because of the provisions of this subsection,
the Administrator may not rely on section 552(b)(3) of such title to
sustain the Administrators action.

(b) Data from health and safety studies

(1) Subsection (a) does not prohibit the disclosure of

(A) any health and safety study which is submitted under this chapter
with respect to

(i) any chemical substance or mixture which, on the date on which such
study is to be disclosed has been offered for commercial distribution,
or

(ii) any chemical substance or mixture for which testing is required
under section   HYPERLINK "http://openjurist.org/15/usc/2603"  2603  of
this title or for which notification is required under section
HYPERLINK "http://openjurist.org/15/usc/2604"  2604  of this title, and

(B) any data reported to, or otherwise obtained by, the Administrator
from a health and safety study which relates to a chemical substance or
mixture described in clause (i) or (ii) of subparagraph (A).

This paragraph does not authorize the release of any data which
discloses processes used in the manufacturing or processing of a
chemical substance or mixture or, in the case of a mixture, the release
of data disclosing the portion of the mixture comprised by any of the
chemical substances in the mixture.

(2) If a request is made to the Administrator under subsection (a) of
section 552 of title 5 for information which is described in the first
sentence of paragraph (1) and which is not information described in the
second sentence of such paragraph, the Administrator may not deny such
request on the basis of subsection (b)(4) of such section.

(c) Designation and release of confidential data

(1) In submitting data under this chapter, a manufacturer, processor,
or distributor in commerce may

(A)  designate the data which such person believes is entitled to
confidential treatment under subsection (a) of this section, and

(B)  submit such designated data separately from other data submitted
under this chapter. A designation under this paragraph shall be made in
writing and in such manner as the Administrator may prescribe.

(2)

(A) Except as provided by subparagraph (B), if the Administrator
proposes to release for inspection data which has been designated under
paragraph (1)(A), the Administrator shall notify, in writing and by
certified mail, the manufacturer, processor, or distributor in commerce
who submitted such data of the intent to release such data. If the
release of such data is to be made pursuant to a request made under
section   HYPERLINK "http://openjurist.org/5/usc/552"  552    HYPERLINK
"http://openjurist.org/5/usc/552" \l "a"  (a)  of title   HYPERLINK
"http://openjurist.org/5/usc"  5 , such notice shall be given
immediately upon approval of such request by the Administrator. The
Administrator may not release such data until the expiration of 30 days
after the manufacturer, processor, or distributor in commerce submitting
such data has received the notice required by this subparagraph.

(B)

(i) Subparagraph (A) shall not apply to the release of information
under paragraph (1), (2), (3), or (4) of subsection (a) of this section,
except that the Administrator may not release data under paragraph (3)
of subsection (a) of this section unless the Administrator has notified
each manufacturer, processor, and distributor in commerce who submitted
such data of such release. Such notice shall be made in writing by
certified mail at least 15 days before the release of such data, except
that if the Administrator determines that the release of such data is
necessary to protect against an imminent, unreasonable risk of injury to
health or the environment, such notice may be made by such means as the
Administrator determines will provide notice at least 24 hours before
such release is made.

(ii) Subparagraph (A) shall not apply to the release of information
described in subsection (b)(1) of this section other than information
described in the second sentence of such subsection.

(d) Criminal penalty for wrongful disclosure

(1) Any officer or employee of the United States or former officer or
employee of the United States, who by virtue of such employment or
official position has obtained possession of, or has access to, material
the disclosure of which is prohibited by subsection (a) of this section,
and who knowing that disclosure of such material is prohibited by such
subsection, willfully discloses the material in any manner to any person
not entitled to receive it, shall be guilty of a misdemeanor and fined
not more than $5,000 or imprisoned for not more than one year, or both.
Section   HYPERLINK "http://openjurist.org/18/usc/1905"  1905  of title
 HYPERLINK "http://openjurist.org/18/usc"  18  does not apply with
respect to the publishing, divulging, disclosure, or making known of, or
making available, information reported or otherwise obtained under this
chapter.

(2) For the purposes of paragraph (1), any contractor with the United
States who is furnished information as authorized by subsection (a)(2)
of this section, and any employee of any such contractor, shall be
considered to be an employee of the United States.

(e) Access by Congress

Notwithstanding any limitation contained in this section or any other
provision of law, all information reported to or otherwise obtained by
the Administrator (or any representative of the Administrator) under
this chapter shall be made available, upon written request of any duly
authorized committee of the Congress, to such committee.


[Federal Register: May 28, 2009 (Volume 74, Number 101)]
[Rules and Regulations]
[Page 25399-25402]
[DOCID:fr28my09-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0486; Directorate Identifier 2009-NM-064-AD;
Amendment 39-15919; AD 2009-11-09]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310 Airplanes and Airbus
Model A300-600 Airplanes

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

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    An A300-600 operator reported a recent event which occurred
during the take-off roll, where a SOGERMA co-pilot seat slid back
uncommanded to the end position. The seat horizontal movement
actuator was replaced on the affected co-pilot seat. At the
following take-off roll the same event occurred, the co-pilot seat
sliding back uncommanded again. * * *
    An unwanted movement of pilot or co-pilot seat in the horizontal
direction is considered as potentially unsafe, especially during the
take-off phase when the speed of the aeroplane is greater than 100
knots and until landing gear retraction.
* * * * *
Uncommanded movement of the pilot and co-pilot seats during takeoff or
landing could interfere with the operation of the airplane and, as a
result, could cause consequent loss of control of the airplane. This AD
requires actions that are intended to address the unsafe condition
described in the MCAI.

DATES: This AD becomes effective June 12, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of June 12, 2009.
    We must receive comments on this AD by June 29, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, 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; 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 regulatory 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 FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency, which is the aviation
authority for the Technical Agent for the Member States of the European
Community, has issued Airworthiness Directive 2009-0084, dated April 9,
2009 (referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    An A300-600 operator reported a recent event which occurred
during the take-off roll, where a SOGERMA co-pilot seat slid back
uncommanded to the end position. The seat horizontal movement
actuator was replaced on the affected co-pilot seat. At the
following take-off roll the same event occurred, the co-pilot seat
sliding back uncommanded again. Further to these events, the
inspection carried out on the two removed actuators ARTUS Part
Number (P/N) RT19H4FX, revealed that the clutch was broken inside
the shaft, thus unlocking the seat horizontal movement.
    An unwanted movement of pilot or co-pilot seat in the horizontal
direction is considered as potentially unsafe, especially during the
take-off phase when the speed of the aeroplane is greater than 100
knots and until landing gear retraction.
    For the reasons described above and pending the development of a
permanent solution, this AD requires the deactivation of the
electrical powered SOGERMA pilot seats

2510112 series and co-pilot seats 2510113 series.
    In addition, this AD provides two (optional) interim solutions
in order to restore a partial seat electrical adjustment (vertical
only) or a full seat electrical adjustment (vertical and horizontal)
by accomplishment of intermediate actions.

Uncommanded movement of the pilot and co-pilot seats during takeoff or
landing could interfere with the operation of the airplane and, as a
result, could cause consequent loss of control of the airplane. You may
obtain further information by examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued All Operators Telex (AOT) A310-25A2203, Revision
02, dated March 2, 2009; and AOT A300-25A6215, Revision 02, dated March
2, 2009. EADS SOGERMA has issued Alert Service Bulletin A2510112-25-
764, Revision 1, dated February 17, 2009; and Inspection Service
Bulletin 2510112-25-807, dated February 20, 2009. The actions described
in this service information are intended to correct the unsafe
condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because an
uncommanded movement of the pilot and co-pilot seats during takeoff or
landing could cause consequent loss of control of the airplane.
Therefore, we determined that notice and opportunity for public comment
before issuing this AD are impracticable and that good cause exists for
making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2009-0486; Directorate
Identifier 2009-NM-064-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

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 above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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 a regulatory 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

0
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 AD:

2009-11-09 Airbus: Amendment 39-15919. Docket No. FAA-2009-0486;
Directorate Identifier 2009-NM-064-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective June 12,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A310-203, A310-204, A310-
221, A310-222, A310-304, A310-322, A310-324, and A310-325 airplanes;
and Airbus Model A300 B4-601, A300 B4-603, A300 B4-605R, A300 B4-
620, A300 B4-622, A300 B4-622R, A300 C4-605R Variant F, A300 F4-605R
and A300 F4-622R airplanes; certificated in any category; all serial
numbers having SOGERMA 2510112 series pilot electrical seats or
SOGERMA 2510113 series co-pilot electrical seats installed.

Subject

    (d) Air Transport Association (ATA) of America Code 25:
Equipment/Furnishings.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:
    An A300-600 operator reported a recent event which occurred
during the take-off roll, where a SOGERMA co-pilot seat slid back
uncommanded to the end position. The seat horizontal movement
actuator was replaced on the affected co-pilot seat. At the
following take-off roll the same event occurred, the co-pilot seat
sliding back uncommanded again. Further to these events, the
inspection carried out on the two removed actuators ARTUS Part
Number (P/N) RT19H4FX, revealed that the clutch was broken inside
the shaft, thus unlocking the seat horizontal movement.
    An unwanted movement of pilot or co-pilot seat in the horizontal
direction is considered as potentially unsafe, especially during the
take-off phase when the speed of the aeroplane is greater than 100
knots and until landing gear retraction.
    For the reasons described above and pending the development of a
permanent solution, this AD requires the deactivation of the
electrical powered SOGERMA pilot seats 2510112 series and co-pilot
seats 2510113 series.
    In addition, this AD provides two (optional) interim solutions
in order to restore a partial seat electrical adjustment (vertical
only) or a full seat electrical adjustment (vertical and horizontal)
by accomplishment of intermediate actions.

Uncommanded movement of the pilot and co-pilot seats during takeoff
or landing could interfere with the operation of the airplane and,
as a result, could cause consequent loss of control of the airplane.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 15 days after the effective date of this AD:
Deactivate the electrical supply of SOGERMA 2510112 series pilot
seats and SOGERMA 2510113 series co-pilot seats, in accordance with
the instructions of Airbus All Operators Telex (AOT) A310-25A2203,
Revision 02, dated March 2, 2009; or AOT A300-25A6215, Revision 02,
dated March 2, 2009; as applicable.
    (2) For optional intermediate action for restoration of the
electrical adjustment of the vertical seat movement only:
Deactivating the electrical powered horizontal movement of SOGERMA
2510112 series pilot seats or SOGERMA 2510113 series co-pilot seats,
in accordance with the instructions of EADS SOGERMA Alert Service
Bulletin A2510112-25-764, Revision 1, dated February 17, 2009,
allows restoration of the vertical adjustment only.
    (3) For optional intermediate action for restoration of the
electrical adjustment of the vertical seat and horizontal seat
movement: Inspecting the position of switch `S4' and the related
shim of SOGERMA 2510112 series pilot seats or SOGERMA 2510113 series
co-pilot seats, in accordance with EADS SOGERMA Inspection Service
Bulletin 2510112-25-807, dated February 20, 2009, allows
reactivation of both horizontal and vertical electrical movements,
provided the measurement results of the inspection are within the
acceptable value indicated in the service bulletin, and provided
that the inspection is repeated thereafter at intervals not to
exceed 2 months. If the measurement result of any inspection is not
within the acceptable value indicated in the EADS SOGERMA Inspection
Service Bulletin 2510112-25-807, dated February 20, 2009, the
horizontal movement must be deactivated before further flight.
    (4) At the applicable time specified in paragraph (f)(4)(i) or
(f)(4)(ii) of this AD: Submit a report of the findings for the first
inspection done in accordance with paragraph (f)(3) of this AD to
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France. The report must include a
detailed fleet inspection report, including measurement values, and
pin and serial numbers for each seat.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was accomplished prior to the effective
date of this AD: Submit the report within 30 days after the
effective date of this AD.
    (5) Modifications made prior to the effective date of this AD in
accordance with EADS SOGERMA Alert Service Bulletin A2510112-25-764,
dated December 19, 2008, are considered acceptable for compliance
with the applicable action specified in this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: None.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Dan
Rodina, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your principal maintenance inspector (PMI) or principal
avionics inspector (PAI), as appropriate, or lacking a principal
inspector, your local Flight Standards District Office. The AMOC
approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0084, dated April 9, 2009; and the service
information listed in Table 1 of this AD for related information.

                  Table 1--Related Service Information
------------------------------------------------------------------------
                                     Revision
             Document                 level               Date
------------------------------------------------------------------------
Airbus All Operators Telex A300-           02  March 2, 2009.
 25A6215.
Airbus All Operators Telex A310-           02  March 2, 2009.
 25A2203.
EADS SOGERMA Alert Service                  1  February 17, 2009.
 Bulletin A2510112-25-764.
EADS SOGERMA Inspection Service         (\1\)  February 20, 2009.
 Bulletin 2510112-25-807.
------------------------------------------------------------------------
\1\ Original.

Material Incorporated by Reference

    (i) You must use Airbus All Operators Telex A310-25A2203,
Revision 02, dated March 2, 2009; or Airbus All Operators Telex
A300-25A6215, Revision 02, dated March 2, 2009; as applicable; to do
the actions required by this AD, unless the AD specifies otherwise.
If you do the optional actions specified by this AD, you must use
EADS SOGERMA Inspection Service Bulletin 2510112-25-807, dated
February 20, 2009; or EADS SOGERMA Alert Service Bulletin A2510112-
25-764, Revision 1, dated February 17, 2009; as applicable; to
perform those actions, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of

this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on May 15, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E9-12322 Filed 5-27-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15212-15213]
[FR Doc No: 2018-07203]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2017-0288]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 23 individuals from the
prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs)
against persons with insulin-treated diabetes mellitus (ITDM) from
operating a commercial motor vehicle (CMV) in interstate commerce. The
exemptions enable these individuals with ITDM to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on February 16, 2018. The
exemptions expire on February 16, 2020.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On January 16, 2018, FMCSA published a notice announcing receipt of
applications from 23 individuals requesting an exemption from diabetes
requirement in 49 CFR 391.41(b)(3) and requested comments from the
public (83 FR 2317). The public comment period ended on February 15,
2018, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    The Agency's decision regarding these exemption applications is
based on the program eligibility criteria and an individualized
assessment of information submitted by each applicant. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the January 16, 2018 Federal
Register notice (83 FR 2317) and will not be repeated in this notice.
    These 23 applicants have had ITDM over a range of 1 to 35 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (two
or more) severe hypoglycemic episodes in the past five years. In each
case, an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must submit a quarterly monitoring checklist completed by
the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) each driver must report within
two business days of occurrence, all episodes of severe hypoglycemia,
significant complications, or inability to manage diabetes; also, any
involvement in an accident or any other adverse event in a CMV or
personal vehicle, whether or not it is related to an episode of
hypoglycemia; (3) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the Medical Examiner at
the time of the annual medical examination; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keeping a copy in his/
her driver's qualification file if he/she is self-employed. The driver
must also have a copy of the exemption when driving, for presentation
to a duly authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 23 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above:

Irah H. Buttgenbach, Jr. (IN)
Scott A. Civitarese (MA)

Cornelius Clark (OH)
Ronald J. Danielson (MN)
Mark A.L. Givan (AR)
Lyle C. Hatfield (MI)
Brian C. Hosea (OR)
James Middlebrook, III (OH)
Thomas B. Miller (VA)
Keith E. Moran (RI)
Christopher R. Pearson (MN)
John C. Plaster (IN)
Glenn E. Rausch (MD)
Ricardo P. Salazar (NM)
Seann D. Sampson (FL)
Alex Shirvani (NY)
Cameron M. Simpson (CA)
Phillip J. Sobczak (WI)
Christoph Trimblett (NJ)
Martin L. Veitz (PA)
Kenneth W. West (OH)
Rodney J. Woods (AL)
Timothy A. Zimmerman (IN)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315.

    Issued on: April 2, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-07203 Filed 4-6-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33564-33568]
[FR Doc No: 2014-13544]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]

Draft Guidance for Industry on Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Drug Supply
Chain Security Act Implementation: Identification of Suspect Product
and Notification.'' The draft guidance addresses new provisions in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Drug Supply Chain Security Act (DSCSA). The draft guidance is intended
to aid certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
terminating notifications regarding illegitimate product. This draft
guidance identifies specific scenarios that could significantly
increase the risk of a suspect product entering the pharmaceutical
distribution supply chain; provides recommendations on how trading
partners can identify the product and determine whether the product is
a suspect product as soon as practicable; and for product that has been
determined to be illegitimate, or (for manufacturers) has a high risk
of illegitimacy, sets forth the process by which trading partners
should notify FDA of illegitimate product and how they must terminate
the notifications, in consultation with FDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 11, 2014. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by August 11, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carolyn Becker, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification.'' On November 27,
2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law.
Section 202 of the DSCSA adds section 582(h)(2) to the FD&C Act (21
U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to aid
certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
terminating notifications regarding an illegitimate product. This
guidance identifies specific scenarios that could significantly
increase the risk of a suspect product entering the pharmaceutical
distribution supply chain and provides recommendations on how trading
partners can identify the product and determine whether the product is
a suspect product as soon as practicable.
    Starting January 1, 2015, section 582 of the FD&C Act requires
trading partners, upon determining that a product in their possession
or control is illegitimate, to notify FDA and all immediate trading
partners (that they have reason to believe may have received the
illegitimate product) not later than 24 hours after making the
determination. Manufacturers are additionally required under section
582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and immediate
trading partners (that the manufacturer has reason to believe may
possess a product manufactured by or purported to be manufactured by
the manufacturer) not later than 24 hours after the manufacturer
determines or is notified by FDA or a trading partner that there is a
high risk that the product is illegitimate. This draft guidance
addresses how trading partners should notify FDA using Form FDA 3911.
In addition, in accordance with section 582(h)(2) of the FD&C Act, this
guidance sets forth the process by which trading partners must
terminate the notifications using Form FDA 3911, in consultation with
FDA, regarding illegitimate product or, for a manufacturer, a product
with a high risk of illegitimacy, under section 582(b)(4)(B),
(c)(4)(B), (d)(4)(B), and (e)(4)(B).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115).

The draft guidance, when finalized, will represent the Agency's current
thinking on identification of suspect product and notification.
Guidance documents generally do not create or confer any rights for or
on any person and do not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations. For this
particular document, section 582 of the FD&C Act gives FDA authority to
issue binding guidance on the process for terminating notifications of
illegitimate product. Specifically, subsection (h)(2)(A) states that
FDA ``shall issue a guidance document to aid trading partners in the
identification of a suspect product and notification termination. Such
guidance document shall . . . set forth the process by which
manufacturers, repackagers, wholesale distributors, and dispensers
shall terminate notifications in consultation with the Secretary
regarding illegitimate product. . . .'' Thus, insofar as section IV.B
of this guidance sets forth the process by which trading partners must
terminate notifications of illegitimate product in consultation with
FDA, it will have binding effect upon finalization.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
are given under this section with an estimate of the reporting and
third-party disclosure burdens. Included in the estimate is the time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the
collection of information.
    We invite 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.
    Title: Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification.
    Description: Under section 202 of the DSCSA, manufacturers,
repackagers, wholesale distributors, and dispensers (e.g., pharmacies)
must: (1) Notify FDA when they have determined that a product in their
possession or control is illegitimate, and for manufacturers, when they
have determined or been notified by FDA or a trading partner that a
product has a high risk of illegitimacy; (2) notify certain immediate
trading partners about an illegitimate product that they may have
received and, for manufacturers, that a product has a high risk of
illegitimacy; (3) terminate notifications regarding illegitimate
products, and, for manufacturers, a product with a high risk of
illegitimacy, in consultation with FDA when the notifications are no
longer necessary; and (4) notify immediate trading partners when the
notifications are terminated.

1. Notifications to FDA

    Under section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), and
(e)(4)(B)(ii) of the FD&C Act, and beginning not later than January 1,
2015, a manufacturer, repackager, wholesale distributor, and dispenser
who determines that a product in its possession or control is
illegitimate, as defined in section 581 of the FD&C Act (21 U.S.C.
360eee), must notify FDA of that determination not later than 24 hours
after the determination is made. In addition, section
582(b)(4)(B)(ii)(II) of the FD&C Act requires manufacturers to notify
FDA when a manufacturer determines or is notified by FDA or a trading
partner that a product poses a high risk of illegitimacy.
    FDA estimates that a total of approximately 5,000 notifications per
year will be made by all manufacturers, repackagers, wholesale
distributors, and dispensers. This estimate includes the notifications
by trading partners who have determined that illegitimate product is in
their possession or control, as well as notifications by manufacturers
that have determined a product poses a high risk of illegitimacy. This
estimate is based on FDA's experience with Field Alert Reports (FARs)
(Form FDA 3331) required to be submitted by holders of approved drug
applications for certain drug quality issues (21 CFR 314.81(b)(1)) \1\
and with reports of the falsification of drug sample records,
diversion, loss, and known theft of prescription drug samples as
currently required under the Prescription Drug Marketing Act (PDMA).\2\
Because manufacturers, repackagers, and wholesale distributors are
responsible for prescription drugs from the manufacturing through
distribution processes, FDA assumes that most notifications of
illegitimate products would be made by these three trading partners.
FDA is combining the estimates for manufacturers and repackagers
because FDA establishment and drug product listing database indicates
that many companies perform activities of both manufacturers and
repackagers. While the DSCSA specifically defines dispensers, for
estimation purposes, FDA is using estimates for pharmacies in general
terms and based on those that must comply with the new requirements
under section 582(d) of the FD&C Act. FDA estimates that approximately
50 percent of the notifications will be made by manufacturers and
repackagers (2,500), 45 percent by wholesaler distributors (2,250), and
5 percent by pharmacies (250).
---------------------------------------------------------------------------

    \1\ FDA review of the number of Field Alert Reports (FARs)
received in calendar year 2013 was approximately 5,000. Because FARs
are incident and product specific, the estimation does not represent
the number of companies that have submitted a FAR to FDA.
    \2\ FDA cursory review of the number of reports of falsified
drug sample records, diversion, loss, or known theft of prescription
drug samples under the PDMA in calendar year 2013 was approximately
5,000. This number is being used for estimation purposes only
because the DSCSA exempts transactions related to the distribution
of product samples by a manufacturer or licensed wholesale
distributor in accordance with section 503(d) of the FD&C Act (21
U.S.C. 353(d)).
---------------------------------------------------------------------------

    FDA estimates that the number of annual notifications will vary
from 0-2 for manufacturers/repackagers, as well as from pharmacies,
with the vast majority of companies making no notifications. While FDA
establishment and drug product listing database currently contains
registrations for approximately 6,500 manufacturers and repackagers, we
estimate that approximately 2,500 manufacturers/repackagers will notify
FDA of illegitimate product an average of one time per year. While FDA
estimates approximately 69,000 pharmacy sites in the United States,
based on data from the National Association of Chain Drug Stores, the
National Community Pharmacists Association, and the American Hospital
Association, we estimate that approximately 250 pharmacies will notify
FDA of illegitimate product an average of one time per year.\3\ Because
approximately

30 wholesale distributors are responsible for over 90 percent of drug
distributions, based on sales,\4\ and because FDA is estimating that
over 2,200 small wholesale distributors might be responsible for the
remaining 10 percent of drug sales, we estimate that each distributor
will make about an average of 1 notification per year to account for
the estimated 2,250 notifications FDA will receive regarding
illegitimate product.
---------------------------------------------------------------------------

    \3\ The estimate of the number of pharmacies in the United
States is based on combining estimates of: (a) 41,000 chain
pharmacies provided in a National Association of Chain Drug Stores
statement for the Senate Budget Committee Conferees (October 29,
2013); (b) 23,000 independent pharmacies represented by the National
Community Pharmacist Association (NCPA) according to NCPA's 2014
media kit; and (c) 5,000 U.S. community hospitals in the United
States, based on 2012 American Hospital Association Annual Survey
and the assumption that each hospital has at least one pharmacy.
    \4\ The estimate of the number of wholesale drug distributors is
based on the Healthcare Distribution Management Association number
of members and estimation of the percentage of all prescription
drugs sold in the United States by these entities provided in
Congressional testimony before the U.S. House of Representatives,
Committee on Energy and Commerce (April 25, 2013).
---------------------------------------------------------------------------

    FDA intends to make available Form FDA 3911 on its Web page for
notifying FDA. Each notification should include information about the
person or entity initiating the notification, the product determined to
be illegitimate, and a description of the circumstances surrounding the
event that prompted the notification. FDA estimates that each
notification will take about 1 hour. The estimated total annual burden
hours for making notifications to FDA is approximately 5,000 hours
annually (table 1).

2. Notifications to Trading Partners of an Illegitimate Product

    Under section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), and
(e)(4)(B)(ii) of the FD&C Act, a trading partner who determines that a
product in its possession is illegitimate must also notify all
immediate trading partners that the trading partner has reason to
believe may have received such illegitimate product of that
determination not later than 24 hours after the determination is made.
In addition, a manufacturer is required, under section
582(b)(4)(B)(ii)(II) of the FD&C Act, to notify all immediate trading
partners that the manufacturer has reason to believe may possess a
product manufactured by or purported to be manufactured by the
manufacturer not later than 24 hours after the manufacturer has
determined or been notified by FDA or a trading partner that the
product has a high risk of illegitimacy.
    Because the extent of distribution of any illegitimate product is
likely to vary from one situation to another, FDA is using estimates
that assume wide distribution of each illegitimate product. FDA
estimates that for each notification made by a manufacturer or
repackager to FDA, approximately 30 trading partners (based on the
number of distributors) will also be notified. This results in
approximately 75,000 notifications annually to trading partners of
manufacturers/repackagers. This estimate includes the notifications by
manufacturers and repackagers who have determined that illegitimate
product is in their possession or control, as well as notifications by
manufacturers that have determined that a product poses a high risk of
illegitimacy.
    FDA estimates that a large wholesale distributor might have up to
4,500 trading partners, but a small wholesale distributor might have
200 trading partners, for an average of approximately 2,350. A
wholesale distributor would notify 2,350 trading partners for each of
the 2,250 illegitimate products identified, resulting in approximately
5,287,500 notifications annually to wholesale distributors' trading
partners.
    FDA estimates that a pharmacy purchases prescription drugs from an
average of two wholesale distributors. Therefore, a pharmacy would
notify 2 trading partners for each of the 250 illegitimate products
identified, resulting in approximately 500 notifications annually to
pharmacy trading partners.
    Manufacturers/repackagers, wholesale distributors, and pharmacies
might notify their trading partners using existing systems and
processes used for similar types of communications, which might
include, but is not limited to, posting of notifications on a company
Web site, sending an email, or mailing or faxing a letter or
notification. The information contained in the notification to the
immediate trading partner should be the same as or based on the
notification that was already submitted to FDA. FDA estimates that for
all trading partners, each notification of immediate trading partners
will take approximately 0.2 hours. The estimated total burden hours of
making notifications to trading partners is approximately 1,072,600
hours annually (table 2).

3. Consultation With FDA and Termination of Notification

    Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and
(e)(4)(B)(iv) of the FD&C Act require that a trading partner, who
determines in consultation with FDA that a notification made under
section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or
(e)(4)(B)(ii) is no longer necessary, must terminate the notification.
The draft guidance sets forth the process by which trading partners
must consult with FDA to terminate notifications that are no longer
necessary.
    FDA is making available to trading partners Form FDA 3911 on its
Web page to request a termination of notification. Each request for
termination of notification must include information about the person
or entity initiating the request for termination, the illegitimate
product or product with a high risk of illegitimacy, the notification
that was issued, and an explanation about what actions have taken place
or what information has become available that make the notification no
longer necessary. The request for a termination will be viewed as the
request for consultation with FDA. FDA estimates that the same amount
of time will be required to provide the information necessary to
request termination as is required to make the notification. The time
required to investigate and resolve an illegitimate product
notification will vary, but FDA assumes that each notification will
eventually be terminated at some point. FDA assumes that the number of
requests for termination of a notification per year will be the same as
the original number of notifications for a given year. The estimated
total burden hours of making requests for termination of notifications
to FDA is approximately 5,000 hours annually (table 3).

4. Notifications to Trading Partners That a Notification Has Been
Terminated

    Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and
(e)(4)(B)(iv) of the FD&C Act require that a trading partner who, in
consultation with FDA, terminates a notification made under section
582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) must
also promptly notify immediate trading partners that the notification
has been terminated.
    FDA estimates that the burden for notifying trading partners of an
illegitimate product and the number of trading partners notified will
be the same as the estimates for notification of termination. The
estimated total burden hours of notifying trading partners that the
notification is terminated is approximately 1,072,600 hours annually
(table 4).
    Description of Respondents: Respondents are drug manufacturers,

repackagers, wholesale distributors, and dispensers and might include
small businesses in these categories.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
      Notifications to FDA          Number of     responses per    Total annual   Average burden    Total hours
                                   respondents      respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers..           2,500                1           2,500          1 hour           2,500
Wholesale Distributors.........           2,250                1           2,250          1 hour           2,250
Dispensers.....................             250                1             250          1 hour             250
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............           5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
   Consultation with FDA and        Number of     responses per    Total annual   Average burden    Total hours
  termination of notification      respondents      respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers..           2,500                1           2,500          1 hour           2,500
Wholesale Distributors.........           2,250                1           2,250          1 hour           2,250
Dispensers.....................             250                1             250          1 hour             250
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............           5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
    Notifications to trading                        Number of
  partners of an illegitimate       Number of    disclosures per   Total annual   Average burden    Total hours
            product                respondents      respondent      disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers..           2,500               30          75,000             .20          15,000
                                                                                (12 minutes)
Wholesale Distributors.........           2,250            2,350       5,287,500             .20       1,057,500
                                                                                (12 minutes)
Dispensers.....................             250                2             500             .20             100
                                                                                (12 minutes)
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............       1,072,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 4--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
    Notifications to trading        Number of    disclosures per   Total annual   Average burden    Total hours
    partners of termination        respondents      respondent      disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers..           2,500               30          75,000             .20          15,000
                                                                                (12 minutes)
Wholesale Distributors.........           2,250            2,350       5,287,500             .20       1,057,500
                                                                                (12 minutes)
Dispensers.....................             250                2             500             .20             100
                                                                                (12 minutes)
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............       1,072,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

5. Capital Costs

    There are no capital costs associated with this collection of
information. For notifications to FDA, manufacturers, repackagers,
wholesale distributors, and dispensers will be accessing and using a
system controlled by FDA. For notifications of immediate trading
partners, manufacturers, repackagers, wholesale distributors, and
dispensers will be using current mechanisms, which might include, but
are not limited to, posting of notifications on a company Web site,
sending an email, or mailing or faxing a letter or notification.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the

docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13544 Filed 6-10-14; 8:45 am]
BILLING CODE 4160-01-P