[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Pages 23548-23549]
[FR Doc No: 2016-08497]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0047]

Denial of Motor Vehicle Defect Petition

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Denial of petition for a defect investigation.

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SUMMARY: This notice sets forth the reasons for the denial of a
petition submitted to NHTSA under 49 U.S.C. 30162, requesting that the
agency commence a proceeding to determine the existence of a defect
related to motor vehicle safety in 2015 Volvo VNL 780 vehicles. After a
review of the petition and other information, NHTSA has concluded that
further expenditure of the agency's investigative resources on the
issues raised by the petition does not appear warranted. The agency
accordingly has denied the petition. The petition is hereinafter
identified as DP15-006.

FOR FURTHER INFORMATION CONTACT: Mr. Nate Seymour, Medium & Heavy Duty
Vehicle Division, Office of Defects Investigation (ODI), NHTSA, 1200
New Jersey Ave. SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: By letter dated August 7, 2015, Mr. Albert
Cusson and Nancy Younger-Cusson wrote to

NHTSA requesting that the agency investigate the issues they previously
identified in vehicle owner questionnaires (VOQ) 10701592 and 10747593
filed with the Agency. While the Petitioner's letter did not comply
precisely with the requirements for petitions found in 49 CFR 552.4,
the Agency is treating it as a petition in accordance with the
regulation.
    ODI understands these issues to include: Cab sway, cab alignment/
bottoming out, and loss of vehicle control due to false triggering of
the advanced vehicle safety systems. NHTSA has reviewed the material
provided by the petitioners and other pertinent data that the agency
gathered as well as test drove the petitioners' vehicle. The results of
this review and NHTSA's analysis of the petition's merit is set forth
in the DP15-006 Evaluation Report, appearing in the public docket
referenced in the heading of this notice.
    For the reasons presented in the Evaluation Report, it is unlikely
that an order concerning notification and remedy of a safety-related
defect would be issued as a result of granting Mr. Albert Cusson and
Nancy Younger-Cusson's request. Therefore, in review of the need to
allocate and prioritize NHTSA's investigative resources, an
investigation on the issues raised by the petition does not appear to
be warranted. Therefore, the petition is denied.

    Authority: 49 U.S.C. 30162(d); delegations of authority at CFR
1.95 and 501.8.

Gregory K. Rea,
Associate Administrator for Enforcement.
[FR Doc. 2016-08497 Filed 4-20-16; 8:45 am]
 BILLING CODE 4910-59-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 								PC Code 	129099

				DP Barcode	D367105

Date                  August 4, 2009

MEMORANDUM

SUBJECT:	Tier I Estimated Environmental Concentrations of Imidacloprid
for the Use in the Human Health Risk Assessment, Registration of a New
Product for Seed Treatment, Sepresto 75WS, and New Use on Bulb
Vegetables (Crop Group 3) for GAUCHO 550SC

FROM:	José L. Meléndez, Chemist

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

THROUGH:	Mah T. Shamim, Branch Chief

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

TO:		Kable Davis, Risk Manager Reviewer

		Venus Eagle, Risk Manager #1

		Insecticide-Rodenticide Branch

		Registration Division (7505P)

AND:		Jennifer R. Tyler, Risk Assessor

		Dana Vogel, Branch Chief

		Registration Action Branch I

		Health Effects Division (7509P)

This memo presents the Tier I Estimated Surface Drinking Water
Concentrations and Estimated Ground Water Concentrations (EDWCs) for
Imidacloprid, calculated using the Tier I aquatic models FIRST and
SCI-GROW, respectively, for use in the human health risk assessment.  It
was found that caneberries and citrus are still the uses with the major
exposure, with an application rate of 0.5 lb a.i./A, and the highest
percent crop area (PCA=0.87), and, therefore, the drinking waters
assessment results do not change from the previous ones.  The previous
Drinking Waters Assessment (DWA) still applies. An electronic copy of
the previous assessment is attached.

The Estimated Drinking Water Concentrations (EDWCs) for imidacloprid
were calculated based on a maximum application rate of 0.5 lb
a.i./A/season.  The acute drinking water concentration in surface water
is 36.0 ppb of imidacloprid, based on applications of the chemical to
citrus.  The cancer/chronic surface drinking water concentration is 17.2
ppb (based on applications to citrus).  The SCI-GROW generated EDWC is
2.09 ppb of imidacloprid, which is recommended for use, both for acute
and chronic exposures.  Table I provides a summary of the Tier I modeled
drinking water concentrations.  Should there be a need for additional
refinements, the EFED can perform a Tier II aquatic assessment, for
surface waters.

Data Gaps and Uncertainties:

The environmental fate database is substantially complete.  An aerobic
aquatic metabolism (Guideline No. 835.4300) study has been required.

Table 1.  Maximum Tier I Estimated  Drinking Water Concentrations
(EDWCs) for drinking water  risk assessment based on ground application
of imidacloprid (for additional details, refer to Attachment A).

DRINKING WATER SOURCE (MODEL USED) 	USE (rate modeled)	MAXIMUM ESTIMATED
DRINKING WATER CONCENTRATION (EDWC) (ppb)

Groundwater             (SCI-GROW)	Citrus  (0.5 lb a.i./A)	Acute and
chronic	     2.09

Surface water        (FIRST)	Citrus  (0.5 lb a.i./A)	Acute	    36.0

	Citrus  (0.5 lb a.i./A)	Chronic	    17.2

Use Characterization

Table 2 is a summary of all agricultural use patterns for imidacloprid
in the proposed labels.  Uses were arranged according to crop groups.
The uses shaded gray are the proposed new ones under Pesticide Amendment
for GAUCHO 550SC (new use added to the label), or Registration
Application for Sepresto 75WS (a proposed new product for seed
treatment, containing imidacloprid and clothianidin as active
ingredients).  The use information was obtained from the proposed labels
for GAUCHO® 550SC (EPA Reg. No. 264-827) and Sepresto 75WS (EPA Reg.
No. 264-XXX, Proposed New Product).

From Table 2 it is noted that of the new uses, only bulb vegetables
(Crop Group 3-07, e.g. onion & garlic) could involve the highest use
rate for a single application at 0.5 lb a.i./A, applied foliarly.  This
rate was assessed for caneberries, using FIRST, in memorandum dated
4/13/07 from R.D. Parker to J.R. Tyler and B. Madden (Attachment A).
Therefore, a new assessment is not required.

Table 2.  Summary use information for imidacloprid, including proposed
(shaded gray) and current (not shaded) uses [labels for GAUCHO® 550SC
(EPA Reg. No. 264-827) and Sepresto 75WS (EPA Reg. No. 264-XXX,
Proposed)].

PURPOSE/ SOURCE	USE	a.i.  oz/ 1000 seed	APP. RATE max. lb a.i./
A/applic.	APP. RATE lb. a.i./     A/season	LABELED METHODS OF
APPLICATION4	COMMENTS

Sepresto 75WS	Root & Tuber veg. (CG 1)	0.00525	0.305	0.5	Seed treatment

	GAUCHO 550SC	Root veg.         (CSG 1B except sugarbeet + kava)	N/A
0.38	0.38	Seed treatment, soil, foliar

	GAUCHO 550SC	Tuberous & Corm veg.      (CSG 1C)	N/A	0.38	0.38	Seed
treatment, soil, foliar

	GAUCHO 550SC	Sugarbeet       (CA only)	N/A	0.18	0.18	Seed treatment,
soil

	Sepresto 75WS	Potato Seed pieces	N/A	0.092	0.092	Seed treatment	0.35 oz
prod/100 lb seed; 7.7 oz prod/A2

GAUCHO 550SC	Potato &     Potato Seed  Piece Treatment	NA	0.31	0.31	Seed
treatment, soil, foliar

	Sepresto 75WS	Leafy Greens veg. (CSG 4A)	0.0094	0.0256	0.5	Seed
treatment

	GAUCHO 550SC	Leafy veg.   (CSG 4A plus watercress)	N/A	0.38	0.38	Seed
treatment, soil, foliar

	Sepresto 75WS	Brassica (Cole) Leafy veg (CG 5)	0.01387	0.0387	0.5	Seed
treatment

	GAUCHO 550SC	Brassica (Cole) Leafy veg (CG 5)	N/A	0.38	0.38	Seed
treatment, soil, foliar

	Sepresto 75WS	Fruiting veg.  (CG 8)	0.00581	0.000358	0.5	Seed treatment

	GAUCHO 550SC	Fruiting veg.  (CG 8) (except pepper & okra)	N/A	0.38	0.38
Seed treatment, soil, foliar	Additional use for planthouses

	Pepper & Okra	N/A	0.5	0.5

Sepresto 75WS	Cucurbit veg. (CG 9)	0.011	0.0459	0.5	Seed treatment

	GAUCHO 550SC	Cucurbit veg. (CG 9)	N/A	0.38	0.38	Seed treatment, soil,
foliar	Addl use for planthouses

Sepresto 75WS	Bulb veg. (CG 3)	0.0024	0.06410	0.5	Seed treatment

	GAUCHO 550SC	Bulb veg.       (CG 3-07)	N/A	0.5	0.5	Seed treatment,
soil, foliar

	Sepresto 75WS	Cereal Grain (CG 15 w/o rice)	N/A	0.031	0.031	Seed
treatment	2.0 oz/100 lb seed; 2.6 oz/A1

GAUCHO 550SC	Cotton	N/A	0.33	0.5	Seed treatment, soil, foliar	Max. 6
applics. a.i./ season

GAUCHO 550SC	Peanut	N/A	0.38	0.38	Seed treatment, soil, foliar

	GAUCHO 550SC	Tobacco	N/A	NS	0.5	Soil, foliar	Max. 1.2 oz prod/ 1000
plants

GAUCHO 550SC	Greenhouse veg. (cucumber & tomato)	N/A	NA	NA3	Foliar	0.6
oz product/ 1000 plants

GAUCHO 550SC	Globe Artichoke	N/A	0.5	0.5	Seed treatment, soil, foliar

	GAUCHO 550SC	Herbs (CS 19A)	N/A	0.38	0.38	Seed treatment, soil, foliar

	GAUCHO 550SC	Leafy Petiole veg. (CSG 4B)	N/A	0.38	0.38	Seed treatment,
soil, foliar

	GAUCHO 550SC	Legume veg.  (CG 6 except   dry soybean	N/A	0.38	0.38	Seed
treatment, soil, foliar

	GAUCHO 550SC	Strawberry	N/A	0.5	0.5	Soil, foliar	Do not use both app.
methods in the same season.

	Use Post-Harvest	N/A	0.38	0.38	Soil, foliar

	NA = Not Available; N/A = Not Applicable; NS = Not Specified; For
GAUCHO 550SC, seed treatment is in the field at planting or shortly
thereafter.

1. Seeding rate 131 lb seeds/A for wheat (representative crop); Source:
 HYPERLINK "http://www.uky.edu/Ag/Wheat/seedrate.html"
http://www.uky.edu/Ag/Wheat/seedrate.html

2. Seeding rate 1600-2200 lb seeds/A

Source:   HYPERLINK
"http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/potat
o.html"
http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/potato
.html

3. Greenhouse uses are not assessed by EFED.

4. General instructions for GAUCHO 550SC:  Aerial applications of GAUCHO
550SC are not allowed.  The product may be applied with ground equipment
or via chemigation.  Applications of GAUCHO 550SC should direct product
into the seed or root zone of crop.  Broadcast foliar applications are
only recommended to seedling flats or trays, or where product is
intended to be washed from foliage to soil prior to drying on foliage.

5. Carrots, representative crop, source for approximate seeding rate:
HYPERLINK "http://pmep.cce.cornell.edu/piap/carrot96/agpractices.html"
http://pmep.cce.cornell.edu/piap/carrot96/agpractices.html  - and
HYPERLINK
"http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/carro
t.html"
http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/carrot
.html  (23000 seeds/oz and 2-2.5 lb seeds/A => 920,000 seeds/A; app rate
for carrots 0.00525 oz/1000 seeds  => 0.30 lb a.i./A)

6. Lettuce, representative crop, source of approximate seeding rate:
HYPERLINK "http://www.ipmcenters.org/cropprofiles/CP_form.cfm"
http://www.ipmcenters.org/cropprofiles/CP_form.cfm     (ultimately,
43000 plants/A => 0.025 lb a.i./A

7. Same source as above (6).  In CA about 44,000 plants cabbage /A =>
0.0038 lb a.i./A

8. Same source as above (6):  In FL, maximum plant density of tomatoes
is around 4,840/A; for tomatoes, the max. application rate is 0.00116 oz
a.i./1000 seed => 0.00035 lb a.i./A (note, transplants are not
considered)

9. Same source as above (6), in FL, cucumbers maximum plant population
is 21,780/A => 0.015 lb a.i./A

10. Onions, representative crop, source for approximate seeding rate:
HYPERLINK "http://www.ag.ndsu.edu/pubs/alt-ag/onions.htm"
http://www.ag.ndsu.edu/pubs/alt-ag/onions.htm    (8000 seeds/oz and 2-4
lb/A => 512000 seeds/A; app. rate for onions 0.0020 oz a.i/1000 seeds.
=> 0.064 lb a.i./A)

  PAGE   1

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[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Notices]
[Pages 20030-20034]
[FR Doc No: 2012-7766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]

Draft Guidance for Industry: Reporting Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke Under the
Federal Food, Drug, and Cosmetic Act; 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 ``Reporting
Harmful and Potentially Harmful Constituents in Tobacco Products and
Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and
Cosmetic Act.'' The purpose of this draft guidance is to assist persons
reporting to FDA the quantities of harmful and potentially harmful
constituents (HPHCs) in tobacco products and tobacco smoke under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance
explains that FDA does not intend, at this time, to enforce reporting
on the entire established HPHC list where a manufacturer or importer
completes testing and reporting for an abbreviated list of HPHCs within
the timeframes specified in the guidance.

DATES: Although you can comment on any guidance at any time (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 June 4, 2012. Submit either electronic or written comments
on the proposed collection of information by June 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive label to assist that office in processing
your request or a fax number to which the draft guidance may be sent.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance, including
comments on the proposed collection of information 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: With regard to the draft guidance:
James Flahive, Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-877-
287-1373<EMAIL_ADDRESS>    With regard to the proposed collection of information: Daniel
Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amends the FD&C Act and
grants FDA authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect public health generally and
to reduce tobacco use by minors. Section 904(a)(3) of the FD&C Act (21
U.S.C. 387d(a)(3)) requires each tobacco product manufacturer or
importer, or an agent, to begin reporting to FDA no later than June 22,
2012, ``all constituents, including smoke constituents, identified by
[FDA] as harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco product.''
Reports must be by the brand and by quantity in each brand and
subbrand. Section 904(c)(1) states that manufacturers of tobacco
products not on the market as of June 22, 2009, must also provide
information reportable under section 904(a)(3) at least 90 days prior
to introducing the product into interstate commerce.
    FDA has taken several steps to identify HPHCs to be reported under
section 904(a)(3), including issuing a final guidance discussing FDA's
current thinking on the meaning of ``harmful and potentially harmful
constituent'' in the context of implementing the HPHC list requirement
(76 FR 5387, January 31, 2011). The guidance is available on the
Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. In addition, on
August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226)
in the Federal Register describing the criteria we tentatively
concluded we would use in identifying the HPHCs for the established
list, including a table of the 96 HPHCs we identified using those
criteria, and asking the public and interested parties to submit
relevant scientific and other information by October 11, 2011. FDA
reviewed comments received in response to the HPHC notice. Elsewhere in
this issue of the Federal Register, FDA is publishing a notice
announcing the established list of HPHCs as required by section 904(e)
of the FD&C Act.
    This draft guidance discusses the information to be reported on
HPHCs in tobacco products and tobacco smoke under section 904(a)(3) of
the FD&C Act. This draft guidance document discusses, among other
things: The statutory requirement for testing and

reporting quantities of HPHCs, who tests and reports quantities of
HPHCs to FDA, what HPHCs will be the focus of FDA enforcement at this
time, when reports are submitted to FDA, what information is reported
to FDA, and how the reports should be submitted to FDA. The draft
guidance notifies manufacturers and importers that at this time, while
industry is developing laboratory capacity to comply with section
904(a)(3), FDA does not intend to enforce the statutory requirement to
submit quantities of all constituents identified by FDA as HPHCs by
June 22, 2012, where manufacturers or importers complete testing and
reporting for an abbreviated list of HPHCs as set forth in the draft
guidance. In particular, at this time, for products that were first
marketed before June 22, 2012, FDA does not intend to enforce the
section 904(a)(3) requirement to test and report quantities of all
HPHCs on FDA's established list where: (1) A manufacturer or importer
(or agents thereof), other than a small tobacco product manufacturer,
submits quantities of the HPHCs on an abbreviated list described in the
draft guidance for all of its products, by brand and subbrand, no later
than September 22, 2012; or (2) a small tobacco product manufacturer
(or agents thereof) submits quantities of HPHCS on the abbreviated list
for all of its products, by brand and subbrand, by December 22, 2012.
In addition, for products first marketed on or after June 22, 2012, the
draft guidance explains that FDA does not intend, at this time, to
enforce the requirement in section 904(c)(1) to test and report
quantities of all HPHCs on FDA's established list for products not
previously on the market if a manufacturer or importer reports
quantities for the abbreviated list of HPHCs at least 90 days prior to
marketing the product in the United States. In addition, the draft
guidance explains that at this time, FDA intends to enforce the HPHC
reporting requirements with respect to manufacturers of finished
tobacco products for consumer use--cigarettes, smokeless tobacco, and
roll-your-own tobacco--and not with respect to manufacturers and
importers of other products, such as components sold to manufacturers
or consumers for incorporation into finished products.
    Although this draft guidance announces an intent to exercise
enforcement discretion for a limited time, FDA intends to move toward
full implementation and enforcement of the statutory requirement to
test and report quantities of all HPHCs on FDA's established list, as
appropriate. We anticipate that this guidance will be revised or
withdrawn as we move toward full implementation. We intend to use the
information submitted under sections 904(a)(3) and 904(c)(1) of the
FD&C Act to meet the requirements of section 904(e) of the FD&C Act
regarding a list of HPHCs in each tobacco product by brand and by
quantity in each brand and subbrand. Also, the information will be used
to comply with section 904(d)(1) of the FD&C Act, which requires FDA to
publish a list of HPHCs, by brand and by quantity in each brand and
subbrand, in a format that is understandable and not misleading to lay
persons.

II. Significance of Guidance

    FDA is issuing this draft guidance document 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
reporting HPHCs in tobacco products and tobacco smoke under section
904(a)(3) of the FD&C Act. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing a notice
of the proposed collection of information set forth in the draft
guidance for industry entitled ``Reporting Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke Under
Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act.''
    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.

Draft Guidance for Industry: Reporting Harmful and Potentially Harmful
Constituents in Tobacco Products and Tobacco Smoke Under Section
904(a)(3) of the Federal Food, Drug, and Cosmetic Act (OMB Control
Number 0910-NEW)

    The purpose of the proposed information collection is to allow FDA
to collect statutorily mandated information regarding HPHCs in tobacco
products and tobacco smoke, by brand and by quantity in each brand and
subbrand. The draft guidance provides an abbreviated list of HPHCs on
which FDA intends to focus enforcement at this time for each of the
following: Cigarette smoke, smokeless tobacco products, and roll-your-
own tobacco and cigarette filler.
    To facilitate the submission of HPHC information, FDA has developed
forms in both paper and electronic formats. Manufacturers or importers,
or an agent, may submit information either electronically or in paper
format. The FDA eSubmitter tool provides electronic forms to streamline
the data entry and submission process for reporting HPHCs. Users of
eSubmitter may also populate an Excel file and import data into
eSubmitter. FDA also provides paper forms for the submission of section
904(a)(3) reports. FDA intends to place draft copies of the paper forms
and screen shots of the electronic form and spreadsheet in this docket.
    Whether respondents decide to submit reports electronically or on
paper, each form provides instructions for filling out and submitting
HPHC information to FDA. The forms contain fields for company
information, product information, and HPHC information. The draft
guidance provides an abbreviated list of HPHCs on which FDA intends to
focus enforcement at this time, and information to assist in the
testing and reporting of HPHCs for cigarette smoke and filler,
smokeless tobacco, and roll-your-own tobacco. FDA has created forms to
assist in the

reporting of HPHC information for each of these product types.
    Description of Respondents: The respondents to this collection of
information include manufacturers or importers who complete testing and
reporting for HPHCs in tobacco products and tobacco smoke under section
904(a)(3) of the FD&C Act. Respondents could also include agents of
manufacturers or importers who complete HPHC testing and reporting.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
      Information collected          Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
            Part 1--Section 904(a)(3) of the FD&C Act (Annualized Estimate of One-time Reporting) \2\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
    Cigarette...................             120           10.10           1,212               2           2,424
    Roll-Your-Own...............              46            3.22             148               2             296
    Smokeless...................             200            1.44             288               2             576
                                                                                ---------------
        Total...................  ..............  ..............  ..............  ..............           3,296
----------------------------------------------------------------------------------------------------------------
2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
    Cigarette Filler............             120           10.1            1,212            9.42          11,417
    Roll-Your-Own...............              46            3.22             148            9.42           1,394
    Smokeless...................             200            1.44             288           12.06           3,473
                                                                                ---------------
        Total...................  ..............  ..............  ..............  ..............          16,284
----------------------------------------------------------------------------------------------------------------
3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
    Cigarette: International                 120           10.1            1,212           23.64          28,652
     Organization for
     Standardization (ISO)
     Regimen....................
    Cigarette: Health Canada                 120           10.1            1,212           23.64          28,652
     Regimen....................
                                                                                ---------------
        Total...................  ..............  ..............  ..............  ..............          57,304
                                                                                ---------------
        Total Section 904(a)(3)   ..............  ..............  ..............  ..............          76,884
         Annualized One-Time
         Burden.................
----------------------------------------------------------------------------------------------------------------
             Part 2--Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) \3\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
    Cigarette...................              18           10.10             182               2             364
    Roll-Your-Own...............               7            3.22              23               2              46
    Smokeless...................              30            1.44              43               2              86
                                                                                ---------------
        Total...................  ..............  ..............  ..............  ..............             496
----------------------------------------------------------------------------------------------------------------
2. Reporting of HPHC Quantities
 in Products
----------------------------------------------------------------------------------------------------------------
    Cigarette Filler............              18           10.1              182            9.42           1,714
    Roll-Your-Own...............               7            3.22              23            9.42             217
    Smokeless...................              30            1.44              43           12.06             519
                                                                                ---------------
        Total...................  ..............  ..............  ..............  ..............           2,450
----------------------------------------------------------------------------------------------------------------
3. Reporting of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
    Cigarette: ISO Regimen......              18           10.1              182           23.64           4,302
    Cigarette: Health Canada                  18           10.1              182           23.64           4,302
     Regimen....................
                                                                                ---------------
        Total...................  ..............  ..............  ..............  ..............           8,604
                                                                                ---------------
        Total Section 904(c)(1)   ..............  ..............  ..............  ..............          11,550
         Burden.................
                                                                                ---------------
        Total Reporting Burden    ..............  ..............  ..............  ..............          88,434
         Hours..................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid
  overcounting the burden each year.
\3\ Annual new product reporting under section 904(c)(1) is estimated to be 15% of the annualized one-time
  burden.

    FDA estimates the one-time reporting burden for this guidance would
be 230,652 hours during the first year for section 904(a)(3) reporting
plus ongoing annual burden of 11,550 hours for section 904(c)(1)
reporting. The burden estimate for this collection of information
includes the time it will take to read the guidance document, test the
products, and prepare the HPHC report.
    To avoid overcounting the one-time reporting burden, FDA has
divided the first year burden by three, annualizing the one-time burden
over the 3-year expected OMB period of approval to avoid double-
counting the one-time projected burden. The one-time burden for year
one is located in part 1 of table 1 of this document, and includes
burden for collections of information gathered under section 904(a)(3).
The annualized total one-time burden in part 1 of table 1 is 76,884
hours (230,652 hours divided by 3), which includes 3,296 hours for
reporting manufacturer or importer company and product information,
16,284 hours for reporting HPHC quantities in products, and 57,304
hours for reporting HPHC quantities in mainstream smoke.
    As shown in table 1, the total annual burden for this collection of
information is estimated to be 88,434 hours, which is the annualized
one-time burden estimate for section 904(a)(3) associated with the
submission of an HPHC (76,884 hours) and the annual burden estimate for
section 904(c)(1) (11,550 hours). We have assumed a one-time burden for
section 904(a)(3) because this draft guidance is intended to remain in
effect while industry is developing laboratory capacity to comply fully
with section 904(a)(3) of the FD&C Act. We also assume any new product
reporting requirements under section 904(c)(1) will be provided
annually to FDA. We also anticipate this guidance will be revised or
withdrawn as FDA moves toward full implementation and enforcement of
the statutory requirement to report quantities by brand and subbrand of
all HPHCs on FDA's established HPHC list.
    Part one of table 1 estimates that 366 respondents (120 cigarette
manufacturers or importers, 200 smokeless manufacturers, and 46 roll-
your-own tobacco manufacturers) will submit 4,942 HPHC reports on a
one-time basis (e.g., 1,648 reports on an annualized basis). As noted
previously, FDA estimates that it will take the manufacturer, importer,
or their agents 230,652 hours on a one time basis, or 76,884 hours
annually, to collect the information necessary to test the products and
submit an HPHC report by brand and subbrand.
    Part one, section one of table 1 addresses the time required for
manufacturers and importers to report their company information:
Company name; mailing address; telephone and FAX numbers; FDA
Establishment Identifier (FEI) number; Data Universal Numbering System
(D-U-N-S) number; and point of contact name, mailing address, and
telephone and FAX numbers. The first section of table 1 also addresses
the time required for manufacturers and importers to report their
product information by entering testing information onto the forms:
Brand and subbrand name; unique product identification number; type of
product identification number; product category and subcategory; and
mean weight and standard deviation of tobacco in product. We estimate
that the burden is no more than 2 hours per response to report company
and product information testing regardless of whether the paper or
electronic form (Form FDA 3787) is used. This estimate is not dependent
on product type, so the estimated burden is the same for cigarettes,
roll-your-own tobacco, and smokeless tobacco products. We estimate that
there are 3,636 cigarette subbrands, 445 roll-your-own tobacco
subbrands, and 861 smokeless tobacco subbrands (4,942 total subbrands)
that must comply with section 904(a)(3) of the FD&C Act. Therefore, the
total annualized burden for reporting company and product information
is 3,296 hours (4,942 respondents x 2 hours = 9,884 one-time hours
divided by 3).
    Part one, section two of table 1 addresses the time required from
manufacturers and importers to report quantities for HPHCs in their
products: Number of replicate measurements; test date range;
manufacture date range; extraction method; separation method; detection
method; and mean quantity and standard deviation of HPHCs. The burden
hour estimates in this section include the time needed to test the
tobacco products, draft testing reports, draft the report for FDA, and
submit the report to FDA. For cigarette filler, smokeless, and roll
your own products, we estimate the burden to draft testing reports,
draft the report for FDA, and submit the report to FDA to be 48,852
one-time hours, or 16,284 annualized burden hours. The burden for each
product type reflects our estimate of the burden to test the tobacco
products (i.e., carry out laboratory work). The per-response burden for
testing cigarette filler and roll-your-own tobacco is the same, as the
same HPHCs must be measured for both product types. The per-response
burden for testing smokeless products is greater than that for the
other two product types because more HPHCs must be tested for smokeless
products than the other two product types.
    Part one, section three of table 1 addresses the time required for
manufacturers and importers to report quantities for HPHCs in cigarette
smoke: The number of replicate measurements; test date range;
manufacture date range; extraction method; separation method; detection
method; and mean quantity and standard deviation of HPHCs. The burden
estimates include the burden to test the tobacco products, draft
testing reports, draft the report for FDA, and submit the report to
FDA. We estimate the one-time burden for this section to be 171,912
hours, or 57,304 annualized hours. The annualized burden reflects our
estimate of the burden to test the tobacco products (i.e., carry out
laboratory work). The burden estimate assumes that manufacturers and
importers report HPHC quantities in cigarette mainstream smoke
according to the two recommended smoking regimens. The total annualized
burden for part one of table 1 (section 904(a)(3) reporting) is 76,884
hours (3,296 hours plus 16,284 hours plus 57,304 hours).
    Part two of table 1 contains estimates for new product information
received under section 904(c)(1). Manufacturers and importers must
report HPHC information under section 904(c)(1) at least 90 days prior
to delivery for introduction into interstate commerce. We estimate that
approximately 15 percent of FDA currently regulated tobacco products in
any given year will require submission of this information. The
estimated total annual burden for section 904(c)(1) is 11,550 hours,
which includes 496 hours to report manufacturer/importer company and
product information, 2,450 hours to report HPHC quantities in products,
and 8,604 hours to report HPHC quantities in mainstream smoke.
    The estimated total annual burden for the reporting of HPHC under
sections 904(a)(3) and 904(c)(1) is 88,434 hours (76,884 annualized
burden hours for section 904(a)(3) reporting plus 11,550 annual burden
hours for section 904(c)(1) reporting).
    We have not estimated any capital costs because we do not believe
there are any capital costs associated with this collection. However,
you may comment on any specific capital costs that you have identified.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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 documents may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain an electronic
version of this guidance document at http://www.regulations.gov and
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7766 Filed 3-30-12; 11:15 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Rules and Regulations]
[Pages 30162-30164]
[FR Doc No: 2021-11810]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0196; Project Identifier 2018-SW-021-AD; Amendment
39-21571; AD 2021-11-09]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Airbus Helicopters Deutschland GmbH Model MBB-BK 117 A-1, MBB-BK 117 A-
3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2, and MBB-BK 117 C-1
helicopters. This AD was prompted by an analysis of the main rotor (M/
R) blade loop area. This AD requires repetitive inspections of certain
M/R blade thimble areas and corrective actions if necessary, as
specified in a European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD, which is incorporated by reference
(IBR). The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective July 12, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 12,
2021.

ADDRESSES: For EASA material in this AD, contact EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
material on the EASA website at https://ad.easa.europa.eu. You may view
this material at the 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 (817)
222-5110. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0196.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0196; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the EASA AD, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Community, has issued EASA AD 2018-0061, dated March 20, 2018
(EASA AD 2018-0061), to correct an unsafe condition for Airbus
Helicopters Deutschland GmbH (AHD) (formerly Eurocopter Deutschland
GmbH, Eurocopter Hubschrauber GmbH, Messerschmitt-B[ouml]lkow-Blohm
GmbH), Airbus Helicopters Inc. (formerly American Eurocopter LLC) Model
MBB-BK117 A-1, MBB-BK117 A-3, MBB-BK117 A-4, MBB-BK117 B-1, MBB-BK117
B-2, and MBB-BK117 C-1 helicopters, all serial numbers.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Airbus Helicopters
Deutschland GmbH Model MBB-BK 117 A-1, MBB-BK 117 A-3, MBB-BK 117 A-4,
MBB-BK 117 B-1, MBB-BK 117 B-2, and MBB-BK 117 C-1 helicopters with an
``affected `angle 0' parts'' or ``affected `angle 1' parts'' installed,
as identified in EASA AD 2018-0061. The NPRM published in the Federal
Register on March 26, 2021 (86 FR 16121). The NPRM was prompted by new
test results from an analysis of the M/R blade loop area, which
revealed that certain M/R blade thimbles require reduced inspection
intervals. The NPRM proposed to require repetitive inspections of
certain M/R blade thimble areas and corrective actions if necessary, as
specified in EASA AD 2018-0061. The FAA is issuing this AD to address
composite failure of the M/R blades, resulting in loss of control of

the helicopter. See EASA AD 2018-0061 for additional background
information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed.

Related Service Information Under 1 CFR Part 51

    EASA AD 2018-0061 specifies compliance intervals to repetitively
inspect certain M/R blades, with a blade sweep angle of 1 degree, for
cracks and resin chippings in the area of the greater thimble radius
and corrective actions, if there is a crack or anomaly. EASA AD 2018-
0061 also specifies compliance intervals to repetitively inspect
certain M/R blades, with a blade sweep angle of 0 degrees, for cracks
and bulging in the teflon foil in the area of the greater thimble
radius and corrective actions, if there is a crack or bulge. Corrective
actions include dispatching the M/R blades to an authorized repair
station, as required.
    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.

Differences Between This AD and the EASA AD

    EASA AD 2018-0061 applies to Model MBB-BK117 A-1, MBB-BK117 A-3,
MBB-BK117 A-4, MBB-BK117 B-1, MBB-BK117 B-2 and MBB-BK117 C-1
helicopters, whereas this AD applies to Model MBB-BK 117 A-1, MBB-BK
117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2, and MBB-BK 117
C-1 helicopters with certain M/R blades installed instead. The service
information required by EASA AD 2018-0061 requires accomplishment of
certain corrective action by ``ECD'' or an authorized service or repair
station, whereas this AD requires performing the corrective action in
accordance with FAA-approved procedures instead. EASA AD 2018-0061
requires revising the Aircraft Maintenance Program (AMP), whereas this
AD does not. EASA AD 2018-0061 allows a tolerance to compliance times,
whereas this AD does not.

Costs of Compliance

    The FAA estimates that this AD affects 216 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates that operators may incur the following
costs in order to comply with this AD.
    Inspecting an M/R blade thimble area takes about 1 work-hour for an
estimated cost of about $85 per M/R blade thimble, per inspection
cycle.
    Repairing or replacing an M/R blade takes up to about 20 work-hours
and parts cost up to about $23,100 for an estimated cost of up to
$24,800 per blade.

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.
    The FAA is 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

    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) Will not affect intrastate aviation in Alaska, 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.

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:

2021-11-09 Airbus Helicopters Deutschland GmbH: Amendment 39-21571;
Docket No. FAA-2021-0196; Project Identifier 2018-SW-021-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective July 12, 2021.

(b) Affected ADs None

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
MBB-BK 117 A-1, MBB-BK 117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-
BK 117 B-2, and MBB-BK 117 C-1 helicopters, certificated in any
category, with an ``affected `angle 0' parts'' or ``affected `angle
1' parts'' installed, as identified in European Aviation Safety
Agency (now European Union Aviation Safety Agency) (EASA) AD 2018-
0061, dated March 20, 2018 (EASA AD 2018-0061).

(d) Subject

    Joint Aircraft System Component (JASC) Code: 6200, Main Rotor
System.

(e) Reason

    This AD was prompted by new test results from a composite
analysis of the main rotor (M/R) blade loop area, which revealed
that certain M/R blade thimbles require reduced inspection
intervals. The FAA is issuing this AD to address composite failure
of an M/R blade, which if not addressed could result in subsequent
loss of control of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2018-0061.

(h) Exceptions to EASA AD 2018-0061

    (1) Where EASA AD 2018-0061 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2018-0061 refers to flight hours, this AD
requires using hours time-in-service (TIS).
    (3) Where Table 1, Table 2, and Note 2 of EASA AD 2018-0061
specify inspection

thresholds, intervals, and a non-cumulative compliance time
tolerance of 10% for certain required compliance times, this AD
requires accomplishing those requirements, as follows:
    (i) For helicopters with an ``affected `angle 0' parts,'' the
compliance time is before accumulating 660 total hours TIS on the
affected part or within 100 hours TIS after the effective date of
this AD, whichever occurs later, and without accumulating 1,600
total hours TIS on the affected part. Thereafter, the compliance
time is at intervals not to exceed 330 hours TIS.
    (ii) For helicopters with an ``affected `angle 1' parts,'' the
compliance time is before accumulating 110 total hours TIS on the
affected part or within 50 hours TIS after the effective date of
this AD, whichever occurs later, and without accumulating 950 total
hours TIS on the affected part. Thereafter, the compliance time is
at intervals not to exceed 110 hours TIS.
    (iii) For helicopters specified in paragraph (c) of this AD,
Note 1 of EASA AD 2018-0061 specifies accumulated FH as, ``Unless
otherwise specified, the FH specified in Table 2 of this AD are
those accumulated since the previous M/R blade thimble inspection.''
This AD requires intervals thereafter to be accumulated since
accomplishment of paragraph (g) of this AD.
    (4) While paragraph (5) and Note 3 of EASA AD 2018-0061 specify
revising the Aircraft Maintenance Program (AMP), this AD does not
require this action.
    (5) Where the service information referenced in EASA AD 2018-
0061 specifies accomplishment of certain corrective action by
``ECD'' or an authorized service or repair station, this AD requires
the corrective actions to be performed by a qualified mechanic.
    (6) Where the service information referenced in EASA AD 2018-
0061 specifies contacting ``ECD'' or an authorized service or repair
station, this AD requires performing the corrective action in
accordance with FAA-approved procedures.
    (7) The ``Remarks'' section of EASA AD 2018-0061 does not apply
to this AD.

(i) Alternative Methods of Compliance (AMOCs):

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (j) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

 (j) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA; telephone (206)
231-3218; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) 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) European Aviation Safety Agency (EASA) AD 2018-0061, dated
March 20, 2018.
    (ii) [Reserved]
    (3) For EASA AD 2018-0061, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the 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, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 15, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-11810 Filed 6-4-21; 8:45 am]
BILLING CODE 4910-13-P


                                                  Attachment E

             Work Sheet used to Calculate State (Reporting Agency) and Applicator Labor Costs
  This attachment is available as part of the electronic docket EPA-HQ-OPP-2016-0460 and is part of the ICR's Supporting Statement

 NAICS: 999200
 State Government
 Labor Category:
 Formula
  Managerial
  Technical
   Clerical
 Unloaded Hourly Rate1
 = W
                                    $41.65
                                    $28.45
                                    $19.47
 Benefits Percentage2
 Lb = B/W
                                     46.0%
                                     46.0%
                                     46.0%
 Benefits per hour
 B = W*Lb
                                    $19.17
                                    $13.09
                                    $8.96
 Loaded Hourly Rate
 Wb = W + B =
 W(1+Lb)
                                    $60.82
                                    $41.54
                                    $28.43
 Overhead Percentage3
 Lo = OH/Wb
                                      50%
                                      50%
                                      50%
 Overhead per hour
 OH = Wb*Lo
                                    $30.41
                                    $20.77
                                    $14.22
 Fully Loaded Hourly
 Rate
 Wf = Wb + OH
 = W + B + OH
                                    $91.23
                                    $62.31
                                    $42.65

 1.  Data Source:  BLS http://www.bls.gov/oes/current/naics4_999200.htm May 2015 data
    NAICS 999200 - State Government
    Standard Occupational Codes:
     Management:   11-0000, Management Occupations
     Technical:	19-0000, Life, Physical, and Social Science Occupations
     Clerical:	43-0000, Office and Administrative Support Occupations
 2. Fringe benefits/wage per hour.
 3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.


[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Rules and Regulations]
[Pages 52407-52410]
[FR Doc No: 2013-19438]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0341; Directorate Identifier 2012-SW-025-AD;
Amendment 39-17557; AD 2013-16-19]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter France (Eurocopter) Model EC120B and EC130B4 helicopters
with a certain emergency flotation gear (float) installed. This AD
requires inspecting the float for chafing of the fabric covering and
adding protectors to the float installation to prevent contact between
the float and the protruding

sections of the installation. This AD was prompted by a report of a
float that would not inflate during overhaul because one of the float
compartments was punctured due to chafing. The actions of this AD are
intended to prevent failure of float and subsequent loss of control of
the helicopter during an emergency water landing.

DATES: This AD is effective September 27, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of September 27,
2013.

ADDRESSES: For service information identified in this AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

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 foreign authority's AD,
any incorporated-by-reference service information, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S.
Department of Transportation, Docket Operations Office, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On April 15, 2013, at 78 FR 22213, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 to include an AD that would apply to Eurocopter Model
EC120B helicopters with a left-hand (LH) emergency flotation gear, part
number (P/N) 215674-0, 215674-1, or 215674-2 installed, fitted with a
float, P/N 215481-0; or with a right-hand (RH) emergency flotation
gear, P/N 215675-0, 215675-1, or 215675-2 installed, fitted with a
float, P/N 215482-0; and Model EC130B4 helicopters with a LH emergency
flotation gear P/N 217227-0 installed, fitted with a float P/N 217174-
0; or with a RH emergency flotation gear P/N 217228-0 installed, fitted
with a float, P/N 217195-0. The NPRM proposed to require inspecting the
float for chafing of the fabric covering and adding protectors to the
float installation to prevent contact between the float and the
protruding sections of the installation. The proposed requirements were
intended to prevent failure of float and subsequent loss of control of
the helicopter during an emergency water landing.
    The NPRM was prompted by AD No. 2011-0185, dated September 23, 2011
(AD 2011-0185), issued by the European Aviation Safety Agency (EASA),
which is the Technical Agent for the Member States of the European
Union. EASA issued AD 2011-0185 to correct an unsafe condition for
Eurocopter Model EC120 and EC130 helicopters. EASA advises that during
overhaul of an emergency flotation gear installation, it was impossible
to inflate the RH float according to the instructions in the equipment
manufacturer's manual. An investigation revealed that one of the
compartments in the float was punctured and several areas of the LH and
RH floats were damaged, caused by chafing between the float and the
protruding sections of the supply bars and banjo unions. To address
this potentially unsafe condition, EASA issued AD No. 2009-0190, dated
August 26, 2009 (AD 2009-0190), which required repetitive inspections
of the floats to detect chafing. Aerazur, the float manufacturer, later
developed protectors to be installed on the floats to eliminate
interference between the float and the blunt parts of the installation.
EASA then issued AD 2011-0185, which superseded AD 2009-0190 and
required installation of the protectors on the floats as terminating
action for the repetitive inspections.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM (78 FR 22213,
April 15, 2013).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed

Related Service Information

    Eurocopter has issued Alert Service Bulletin (ASB) No. 05A011,
Revision 0, dated June 8, 2009 (ASB 05A011), for Model EC120B
helicopters and ASB No. 05A008, Revision 0, dated June 8, 2009 (ASB
05A008), for Model EC130B4 helicopters. Both ASBs specify inspecting
the floats for deterioration and chafing at specified intervals and, if
necessary, repairing the floats.
    Eurocopter has also issued ASB No. EC120-25A026, Revision 0, dated
July 11, 2011 (ASB EC120-25A026), for Model EC120B helicopters and ASB
No. EC130-25A042, Revision 0, dated July 11, 2011 (ASB EC130-25A042),
for Model EC130B4 helicopters. Both ASBs specify modifying certain
part-numbered LH and RH emergency flotation gear by adding protectors
onto the rear bracket and supply couplings of the float installation.
The ASBs specify following procedures in Aerazur Service Bulletin (SB)
No. 25-69-87, dated March 14, 2011, for floats installed on Model
EC120B helicopters and Aerazur SB No. 25-69-58, dated March 14, 2011,
for floats installed on Model EC130B4 helicopters. Each Aerazur SB is
incorporated as an appendix to the corresponding Eurocopter ASB.

Costs of Compliance

    We estimate that this AD will affect 60 helicopters of U.S.
Registry. Based on an average labor rate of $85 per work-hour, we
estimate that operators may incur the following costs to comply with
this AD. Inspecting the floats for chafing will require about .5 hour,
for a cost per helicopter of $43, and a cost to U.S. operators of
$2,580. Modifying the floats with protective covers will require about
1 hour and required parts cost about $500, for a cost per helicopter of
$585, and a cost to U.S. operators of $35,100. The total estimated cost
of this AD is $628 per helicopter and $37,680 for the U.S. operator
fleet.

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 helicopters identified in this
rulemaking action.

Regulatory Findings

    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 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):

2013-16-19 Eurocopter France: Amendment 39-17557; Docket No. FAA-
2013-0341; Directorate Identifier 2012-SW-025-AD.

(a) Applicability

    (1) This AD applies to the following helicopters, certificated
in any category:
    (i) Model EC120B helicopters with a left-hand (LH) emergency
flotation gear, part number (P/N) 215674-0, 215674-1, or 215674-2
installed, fitted with a float, P/N 215481-0; or with a right-hand
(RH) emergency flotation gear, P/N 215675-0, 215675-1, or 215675-2
installed, fitted with a float, P/N 215482-0; and
    (ii) Model EC130B4 helicopters with a LH emergency flotation
gear P/N 217227-0 installed, fitted with a float P/N 217174-0; or
with a RH emergency flotation gear P/N 217228-0 installed, fitted
with a float, P/N 217195-0.

 (b) Unsafe Condition

    This AD defines the unsafe condition as chafing of the float due
to contact with the protruding sections of the supply bars and banjo
sections of the emergency flotation gear installation. This
condition could result in the float becoming punctured, failure of
the float to inflate, and subsequent loss of control of the
helicopter during an emergency water landing.

(c) Effective Date

    This AD becomes effective September 27, 2013.

(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 emergency flotation gear that have accumulated 250 or
more hours time-in service (TIS), within 50 hours TIS, accomplish
the following:
    (i) Undo the Velcro tapes and remove the break laces. Remove the
caps from the cover end. Unfold the cover.
    (ii) Inspect each float area in contact with the emergency
flotation gear protruding parts (supply bar, banjo union, and
fittings) for chafing as shown in Figure 1 of Eurocopter Alert
Service Bulletin (ASB) No. 05A011, Revision 0, dated June 8, 2009,
or Eurocopter ASB No. 05A008, Revision 0, dated June 8, 2009, as
appropriate for your model helicopter.
    (iii) If there is any chafing between the protruding parts and
the float fabric, before further flight, inspect the flotation gear.
    (A) Unfold and visually inspect the float assemblies for any
cuts, tears, punctures, or abrasion. Replace the cover if the
internal polycarbonate sheet is cut or if the cover is cut or
punctured.
    (B) Lightly inflate the floats to approximately 50 hectopascals
through the manual inflating valve and inspect the fabric panels and
girts for any cuts, tears, punctures, or abrasion. If there is a
cut, tear, puncture, or any abrasion, repair the float.
    (2) For emergency floatation gear that have accumulated less
than 250 hours TIS, on or before accumulating 300 hours TIS, inspect
the float gear as described in paragraph (e)(1)(i) through (iii) of
this AD.
    (3) Within 300 hours TIS:
    (i) For Model EC120B helicopters, install protectors on and re-
identify the P/N of each LH and RH emergency floatation gear as
described in the Operating Instructions, paragraph 2.C., of Aerazur
Service Bulletin (SB) No. 25-69-87, dated March 14, 2011. The
Aerazur SB is attached as an appendix to Eurocopter Alert Service
Bulletin (ASB) No. EC120-25A026, Revision 0, dated July 11, 2011.
    (ii) For Model EC130B4 helicopters, install protectors on and
re-identify the P/N of each LH and RH emergency floatation gear as
described in the Operating Instructions, paragraph 2., of Aerazur SB
No. 25-69-58, dated March 14, 2011. The Aerazur SB is attached as an
appendix to Eurocopter ASB No. EC130-25A042, Revision 0, dated July
11, 2011.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Gary Roach, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; 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

    (1) The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2011-0185, dated September 23, 2011, which can
be found in the AD Docket on the Internet at http://www.regulations.gov.
    (2) Eurocopter ASB No. EC120-25A026, Revision 0, dated July 11,
2011, and Eurocopter ASB No. EC130-25A042, Revision 0, dated July
11, 2011, which are not incorporated by reference, contain
additional information about the subject of this AD. You may view
this service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 3212: Emergency
Flotation Section.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) 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) Aerazur SB No. 25-69-58, dated March 14, 2011, which is
attached as an appendix to Eurocopter ASB No. EC130-25A042, Revision
0, dated July 11, 2011.
    (ii) Aerazur SB No. 25-69-87, dated March 14, 2011, which is
attached as an appendix to Eurocopter ASB No. EC120-25A026, Revision
0, dated July 11, 2011.
    (iii) Eurocopter ASB No. 05A008, Revision 0, dated June 8, 2009.
    (iv) Eurocopter ASB No. 05A011, Revision 0, dated June 8, 2009.
    (3) For Eurocopter and Aerazur service information identified in
this AD, contact American Eurocopter Corporation, 2701 N. Forum
Drive, Grand Prairie, TX 75052; telephone<PHONE_NUMBER> or (800)
232-0323; fax<PHONE_NUMBER>; or at http://www.eurocopter.com/techpub.
    (4) You may view this service information that is incorporated
by reference in the AD Docket on the Internet at http://www.regulations.gov.
    (5) You may also 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 August 2, 2013.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2013-19438 Filed 8-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 29, 2009 (Volume 74, Number 208)]
[Notices]
[Page 55860-55861]
[DOCID:fr29oc09-104]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0040]

The Standard on 4,4'-Methylenedianiline in General Industry;
Extension of the Office of Management and Budget's (OMB) Approval of
Information Collection (Paperwork) Requirements

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

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Standard on 4,4'-
Methylenedianiline in General Industry (29 CFR 1910.1050).

DATES: Comments must be submitted (postmarked, sent, or received) by
December 28, 2009.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2009-0040,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2009-
0040). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Jamaa N. Hill
at the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Jamaa N. Hill or Todd Owen,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and reduce to
the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    The information collection requirements specified in the 4,4'-
Methylenedianiline Standard in General Industry (the ``MDA Standard'')
(29 CFR 1910.1050) protect workers from the adverse health effects that
may result from their exposure to MDA, including cancer, liver and skin
disease. The major paperwork requirements specify that employers must
perform initial, periodic, and additional exposure monitoring; notify
each worker in writing of their results as soon as possible but no
later than 5 days after receiving exposure monitoring results; and
routinely inspect the hands, face, and forearms of each worker
potentially exposed to MDA for signs of dermal exposure to MDA.
Employers must also: Establish a written compliance program; institute
a respiratory protection program in accordance with 29 CFR 1910.134
(OSHA's Respiratory Protection Standard); and develop a written
emergency plan for any construction operation that could have an
emergency (i.e., an unexpected and potentially hazardous release of
MDA).
    Employers must label any material or products containing MDA,
including containers used to store MDA-contaminated protective clothing
and

equipment. They also must inform personnel who launder MDA-contaminated
clothing of the requirement to prevent release of MDA, while personnel
who launder or clean MDA-contaminated protective clothing or equipment
must receive information about the potentially harmful effects of MDA.
In addition, employers are to post warning signs at entrances or
accessways to regulated areas, as well as train workers exposed to MDA
at the time of their initial assignment, and at least annually
thereafter.
    Other paperwork provisions of the MDA Standard require employers to
provide workers with medical examinations, including initial, periodic,
emergency and follow-up examinations. As part of the medical
surveillance program, employers must ensure that the examining
physician receives specific written information, and that they obtain
from the physician a written opinion regarding the worker's medical
results and exposure limitations.
    The MDA Standard also specifies that employers are to establish and
maintain exposure monitoring and medical surveillance records for each
worker who is subject to these respective requirements, make any
required record available to OSHA compliance officers and the National
Institute for Occupational Safety and Health (NIOSH) for examination
and copying, and provide exposure monitoring and medical surveillance
records to workers and their designated representatives. Finally,
employers who cease to do business within the period specified for
retaining exposure monitoring and medical surveillance records, and who
have no successor employer, must notify NIOSH at least 90 days before
disposing of the records and transmit the records to NIOSH if so
requested.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the collection
of information requirements contained in the 4,4'-Methylenedianiline in
General Industry Standard (29 CFR 1910.1050). The Agency is requesting
an adjustment to the burden hours from 293 hours to 310 hours (an
increase of 17 burden hours). This increase is the result of increasing
the job turnover rate from 10% to 27%, resulting in an increased number
of workers that are receiving medical examinations and being trained.
    OSHA will summarize the comments submitted in response to this
notice, and will include this summary in its request to OMB to extend
the approval of the information collection requirements contained in
the Standard.
    Type of Review: Extension of a currently approved collection.
    Title: 4,4'-Methylenedianiline in General Industry (29 CFR
1910.1050).
    OMB Number: 1218-0184.
    Affected Public: Business or other for-profits; not-for-profit
institutions; Federal Government; State, Local, or Tribal Governments.
     Total Respondents: 10.
    Frequency: On occasion.
    Estimated Time per Response: Varies from 5 minutes (.08 hour) for
employers to provide information to the physician to 2 hours for
initial monitoring.
    Total Burden Hours: 310.
    Estimated Cost (Operation and Maintenance): $21,428.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and OSHA docket number for the ICR (Docket No. OSHA-2009-0040). You may
supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as Social Security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available through the Web site's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available through the Web site, and for assistance
in using the Internet to locate docket submissions.

V. Authority and Signature

    Jordan Barab, Acting Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2007 (72 FR
31160).

    Signed at Washington, DC, this 26th day of October 2009.
Jordan Barab,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E9-26075 Filed 10-28-09; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6730-6731]
[FR Doc No: 2018-03028]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-2014]

Reports, Forms, and Record Keeping Requirements Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted below is being forwarded to the Office of Management and
Budget (OMB) for review and comments. A Federal Register Notice with a
60-day comment period soliciting comments on the following information
collection was published on October 20, 2017 (82 FR 48891). Two
comments were received. The content of neither comment related to the
proposed data collection.

DATES: Comments must be submitted on or before March 16, 2018.

ADDRESSES: Send comments, within 30 days, regarding the burden
estimate, including suggestions for reducing the burden, to the Office
of Management and Budget, Attention: Desk Officer for the Office of the
Secretary of Transportation, 725 17th Street NW, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Ms. Laurie Flaherty, Coordinator,
National 911 Program, Office of Emergency Medical Services (NPD-400),
National Highway Traffic Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, Room W44-322, Washington, DC
20590. Ms. Flaherty's phone number is<PHONE_NUMBER> and her email
address is [email protected]. Please identify the relevant
collection of information by referring to its OMB Control Number.

SUPPLEMENTARY INFORMATION:

    Title: National 911 Profile Database.
    OMB Control Number: 2127-0679.
    Type of Request: Renewal/New of an information collection.
    Abstract: The National 911 Profile Database is funded by the
National 911 Program, which is housed within the Office of Emergency
Medical Services at the National Highway Traffic Safety Administration,
part of the U.S. Department of Transportation. The National 911 Program
is proposing to continue to collect and aggregate information from
State level reporting entities that can be used to measure the progress
of 911 authorities across the country in upgrading their existing
operations--and migrating to--digital, internet-Protocol-based
emergency communication networks. The data will be maintained in a
``National 911 Profile Database.''
    One of the objectives of the National 911 Program is to develop,
collect, and disseminate information concerning practices, procedures,
and technology used in the implementation of 911 services and to
support 911 Public Safety Answering Points (PSAPs) and related State
and local agencies for 911 deployment and operations. The National 911
Profile Database can be used to follow the progress of 911 authorities
in enhancing their existing systems and implementing next-generation
networks for more advanced systems. The information can also be used to
identify ways in which the National 911 Program can support State and
local 911 authorities in the transition process.
    Affected Public: Under this proposed effort, the National 911
Program would specifically request reporting entities to voluntarily
collect and annually report the data described above utilizing a Web-
based data collection tool. Reporting entities are State-level 911
program officials, and the data reported will reflect State-level
aggregated data.
    Estimated Number of Respondents: The total maximum number of
respondents is identified as 56, including the 50 States and the six
U.S. Territories of Guam, U.S. Minor Outlying Islands, American Samoa,
Mariana Islands, U.S. Virgin Islands, and Puerto Rico.
    Frequency: The reporting entities will be requested to submit data
annually relating to their State or territory, using the Web-based tool
described above.
    Estimated Total Annual Burden Hours: NHTSA estimates that
submitting responses to the questions included in the proposed survey
instrument utilizing the Web-based tool would require an average of 98
hours per state to collect, aggregate and submit. Estimating the
maximum number of respondents to be 56, this would result in a total
burden of 5,488 hours. The respondents would not incur any reporting
costs from the information collection beyond the time it takes to
gather the information, prepare it for reporting, and then populate the
Web-based data collection tool. The respondents also would not incur
any recordkeeping burden or recordkeeping costs from the information
collection. The total estimated costs to respondents or record-keepers
are based on the following: The total hour burden of the collection of
information equaling 5,488 hours. Respondents will be State, territory,
and tribal government management personnel. To estimate reasonable
staff expenses to respond to this information collection, the Agencies
reviewed the Bureau of Labor Statistics (BLS) Occupational Outlook
Handbook and determined that the Administrative Services Manager
description closely aligns with the positions of recipient staff
responsible for completing this request. BLS lists a median salary of
$86,100 annually, amounting to $41.40 per hour. There are no capital,
start-up, or annual operation and maintenance costs involved in the
collection of information. Total cost based on hour's burden equals
$227,203.20.
    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department and whether the information will have
practical utility; (b) the accuracy of the Department's estimate of the
burden of the proposed information collection; (c) ways to enhance the
quality, utility, and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information on
respondents, including the use of automated collection techniques or
other forms of information technology.

    Authority:  44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC, on February 9, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-03028 Filed 2-13-18; 8:45 am]
 BILLING CODE 4910-59-P