[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Notices]
[Pages 47551-47554]
[FR Doc No: 2023-15626]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2023-0002-N-23]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of withdrawal; reissuance of information collection;
request for comment.

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SUMMARY: On July 5, 2023, FRA published a 30-day notice of information
collection; request for comment in the Federal Register. FR Doc. 2023-
08413. Due to technical issues as the result of which FRA did not
receive two timely-filed comment letters until after the comment period
closed, FRA is withdrawing the July 5, 2023, notice of information
collection; request for comment and re-issuing the 30-day notice to
address the two additional comments. Accordingly, this notice
supersedes the July 5, 2023, notice.

DATES: Interested persons are invited to submit comments on or before
August 23, 2023.

ADDRESSES: Written comments and recommendations for the proposed
information collection request (ICR) should be sent within 30 days of
publication of this notice to www.reginfo.gov/public/do/PRAMain. Find
the particular ICR by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Ms. Arlette Mussington, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER> or Ms. Joanne Swafford, Information
Collection Clearance Officer, at email:

[email protected] or telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On April 21, 2023, FRA
published a 60-day notice in the Federal Register soliciting public
comment on the ICR for which it is now seeking Office of Management and
Budget (OMB) approval. See 88 FR 24657. On July 5, 2023, FRA published
a 30-day notice in the Federal Register, 88 FR 42999. Due to technical
issues in which FRA did not receive two timely-filed comment letters
until after the comment period closed, FRA is withdrawing the July 5,
2023, notice of information collection; request for comment and re-
issuing it to address the two additional comment letters.\1\ In
addition, FRA has made adjustments to the total number of responses and
burden hours in the PRA table that was previously published in the 60-
day notice. At this time, FRA is forwarding the ICR to OMB for review
and comment.\2\
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    \1\ On July 5, 2023, FRA published a 30-day notice, 88 FR 42999,
that discussed and responded to one comment letter, 88 FR 24657. FRA
was made aware of two additional, timely-filed comment letters that
were received after the close of the 60-day comment period. FRA is
withdrawing and re-issuing the 30-day notice to summarize and
incorporate the two comment letters. For completeness, FRA will also
re-print its summary and response to the third comment letter
discussed in the July 5, 2023, notice.
    \2\ Once alerted to the fact that FRA received two additional
comment letters and that FRA planned to withdraw and re-issue a 30-
day notice, DOT did not certify or forward the supporting materials
for OMB review.
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    In a letter dated June 20, 2023, The President of the
Transportation Trades Department, AFL-CIO (TTD), expressed strong
support for this ICR. TTD noted that FRA's proposed collection of
information concerning train lengths, in feet, and number of crew
members aboard a controlling locomotive involved in an accident at the
time of such accident would bring FRA into compliance with the mandate
in the Infrastructure Investment and Jobs Act (IIJA). TTD requests that
FRA amend Form FRA F 6180.54 by adding this information on a permanent
basis and by incorporating it into a location on the form.
Additionally, TTD recommends that FRA take the additional step of
collecting information about train weight distribution, number of
buffer cars between cars containing hazardous materials, crew member
locations, presence of distributed power units, and synchronous or
asynchronous operating modes.
    FRA is taking TTD's suggestions under advisement and may
incorporate some or all of the suggested information at a future date.
Additionally, FRA is reviewing and considering updates to the data
collected on the Form FRA F 6180.54, and TTD's suggestions will be
considered for inclusion in a future version of the form.
    In a comment letter dated June 20, 2023, the Association of
American Railroads (AAR) raised several concerns. AAR asserts that FRA
uses an artificially low monetary reporting threshold and its failure
to incorporate the latest data decreases the utility of the reporting
process. While FRA appreciates AAR's concern, this comment does not
fall within the scope of the current ICR concerning the proposed
paperwork burdens associated with accident/incident reporting and
recordkeeping and thus, will not be addressed here.
    AAR also asserts that FRA underestimates the amount of time
required to gather information on crew size and train length because
railroads, at a minimum, need to run separate reports and conduct
searches to find this information. In response to AAR's feedback, FRA
reviewed the estimate for the average time each railroad will need to
provide information on crew size and train length in Special Study
Blocks 49a and 49b. FRA disagrees with AAR's conclusion that railroads
need more time to collect this information because the reporting data
is readily available to railroads at the onset of the accident.
Accordingly, FRA's estimate for the average time per response and the
resulting estimated paperwork burden will remain unchanged.
    AAR also notes that the IIJA limits the time period for the
information collection to four years as opposed to FRA's proposed five
years. After further consideration, FRA is revising its collection plan
and proposes to collect this information for a projected four-year
period in conformance with the time period set out by the IIJA.
However, as FRA noted in response to TTD's suggestion of a permanent
collection, FRA is reviewing and considering updates to the data
collected on the FRA F 6180.54 form.
    AAR also requests that FRA clarify reporting requirements for
Special Study Blocks 49a and 49b and notes that in the FRA Guide for
Preparing Accident/Incident Reports, Special Study Block 49a is
currently used to report the type of track an accident occurred on and
in Special Study Block 49b, FRA has instructed railroads to provide
information related to the number of cars carrying crude oil. In
response to this feedback, FRA will modify the instructions for the
Special Study Blocks on its website. Additionally, updates to the FRA
Guide for Preparing Accident/Incident Reports are in progress.
    AAR's final assertion is that FRA's delayed action undermines its
existing train crew size rulemaking activities. While FRA appreciates
this feedback, it does not fall within the scope of the current ICR
concerning the paperwork burdens associated with accident/incident
reporting and recordkeeping and thus, will not be addressed here.
    The Chief Economist of the Bureau of Economic Analysis (BEA) sent
an electronic letter dated May 30, 2023, expressing BEA's strong
support for FRA's continued collection of data on the Accident/Incident
Reporting and Recordkeeping forms. The Chief Economist noted that the
data collected on these forms are crucial to key components of BEA's
economic analyses and requested that FRA keep BEA informed of any
modifications to these forms.
    Before OMB decides whether to approve this proposed collection of
information, it must provide 30-days' notice for public comment.
Federal law requires OMB to approve or disapprove paperwork packages
between 30 and 60 days after the 30-day notice is published. 44 U.S.C.
3507(b)-(c); 5 CFR 1320.12(d); see also 60 FR 44978, 44983, Aug. 29,
1995. This ICR responds to the information collection mandate in
section 22421(b) of the IIJA and also provides routine updates to 49
CFR part 225's overall ICR renewal.
    OMB believes the 30-day notice informs the regulated community to
file relevant comments and affords the agency adequate time to digest
public comments before it renders a decision. 60 FR 44983, Aug. 29,
1995. Therefore, respondents should submit their respective comments to
OMB within 30 days of publication to best ensure having their full
effect.
    Comments are invited on the following ICR regarding: (1) whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being

collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Accident/Incident Reporting and Recordkeeping.
    OMB Control Number: 2130-0500.
    Abstract: The railroad accident/incident reporting regulations in
49 CFR part 225 require railroads to submit reports summarizing
collisions, derailments, and certain other accidents/incidents
involving damages above a periodically revised dollar threshold, as
well as certain injuries to passengers, employees, and other persons on
railroad property. As the reporting requirements and the information
needed regarding each category of accident/incident are unique, a
different form is used for each category.
    In response to the mandate in IIJA section 22421,\3\ FRA intends to
utilize Form FRA F 6180.54 Special Study Blocks 49a and 49b to collect
the following information for a projected four-year period: (1) the
length of the involved trains, in feet, and (2) the number of crew
members who were aboard a controlling locomotive involved in an
accident at the time of such accident. This modification produces a
minimal additional burden with respect to what is already being
reported, as FRA estimates that the utilization of the Special Study
Blocks will require an additional 2 minutes to complete, for a total
average burden time of approximately 2 hours and 2 minutes per form,
adding an additional 57 hours to the overall collection request.
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    \3\ Specifically, IIJA section 22421(b) requires FRA to update
Special Study Block 49 on Form FRA F 6180.54, for a period of four
years, to collect information on: (1) the number of cars and length
of trains involved in an accident/incident; and (2) the number of
crew members who were aboard a controlling locomotive involved in an
accident at the time of such accident. Railroads are already
required to report the number of cars in the consist of a train
involved in an accident on Form FRA F 6180.54, Field 35.
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    Additionally, in this 30-day notice, FRA adjusts its estimated
paperwork burden for the total number of responses and total burden
hours to correct two calculation errors. Specifically, FRA updates the
total number of responses from 85,570 to 88,176 and the total numbers
of burden hours from 30,283 to 30,284 hours.
    Specifically, under Sec.  225.19(d), FRA expects submissions will
decrease significantly from 11,636 hours to 7,040 hours due to a
reduction in the number of injuries reported in the last two years.
There is no change in the method of collection; this is a routine
update for this 3-year ICR renewal period.
    Type of Request: Revision of a currently approved collection.
    Affected Public: Businesses
    Form(s): FRA F 6180.54; .55; .55a; .56; .57; .78; .81; .97; .98;
.107; .150.
    Respondent Universe: 784 railroads.
    Frequency of Submission: On occasion.

                                                                    Reporting Burden
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                                                                                Total cost
            CFR section                Respondent universe         Total annual responses     Average time per response   Total annual    equivalent in
                                                                                burden hours     U.S. dollar
                                                               (A)..........................  (B)......................     (C = A * B)         (D = C *
                                                                                wage rates) \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.6(a)--Consolidated reporting--  784 railroads............  0.33 requests................  40.00 hours..............           13.20        $1,028.41
 Request to FRA by parent
 corporation to treat its commonly
 controlled carriers as a single
 railroad carrier for purposes of
 this part.
                                   ---------------------------------------------------------------------------------------------------------------------
    --(b) Written agreement by      The burden for this requirement is included in Sec.   225.6(a).
     parent corporation with FRA
     on specific subsidiaries
     included in its railroad
     system.
                                   ---------------------------------------------------------------------------------------------------------------------
    --(c) Notification by parent    The burden for this requirement is included in Sec.   225.6(a).
     corporation regarding any
     change in the subsidiaries
     making up its railroad system
     and amended written agreement
     with FRA.
                                   ---------------------------------------------------------------------------------------------------------------------
225.9--Telephonic reports of        784 railroads............  2,589.00 phone reports.......  15.00 minutes............          647.25        50,427.25
 certain accidents/incidents and
 other events.
225.11--Reporting of accidents/     784 railroads............  1,699.00 forms...............  2 hours + 2 minutes......        3,454.63       269,150.22
 incidents--Form FRA F 6180.54
 (IIJA created an additional
 burden of 2 minutes to what is
 already being reported.).
225.12(a)--Rail equipment accident/ 784 railroads............  732.00 forms.................  15.00 minutes............          183.00        14,257.53
 incident reports alleging human
 factor as cause--Form FRA F
 6180.81.
    --(b) Part I Form FRA F         784 railroads............  800 notices + 800 notice       10 minutes + 3 minutes...          333.83        26,008.70
     6180.78 (Notices).                                         copies + 3,200 copies + 10
                                                                copies.
    --(c) Joint operations........  784 railroads............  73.00 reports................  20.00 minutes............           24.00         1,869.84
    --(d) Late identification.....  784 railroads............  20 attachments + 20 notices..  10.00 minutes............            6.67           519.66
    --(g) Employee statement        Railroad employees.......  60.00 statements.............  1.50 hours...............           90.00         7,011.90
     supplementing railroad
     accident report (Part II Form
     FRA 6180.78).
    --(g)(3) Employee confidential  Railroad employees.......  5.00 letters.................  2.00 hours...............           10.00           779.10
     letter.
225.13(A)--Late reports--RR         784 railroads............  50.00 late reports...........  2.00 hours...............          100.00         7,791.00
 discovery of improperly omitted
 report of accident/incident.
    --(B) RR late/amended report    784 railroads............  20 amended reports + 30        1 hour + 3 minutes.......           21.50         1,675.07
     of accident/incident based on                              copies.
     employee statement
     supplementing RR accident
     report.
225.18(a)--RR narrative report of   784 railroads............  12.00 reports................  15.00 minutes............            3.00           233.73
 possible alcohol/drug involvement
 in accident/incident.
    --(b) Reports required by Sec.  784 railroads............  5.00 reports.................  30.00 minutes............            2.50           194.78
       219.209(b) appended to rail
     equipment accident/incident
     report.
225.19(a)--Rail-highway grade       784 railroads............  2,161.50 forms...............  2.00 hours...............        4,323.00       336,804.93
 crossing accident/incident
 report--Form FRA F 6180.57.

    --(d) Death, injury, or         784 railroads............  7,040.00 forms...............  1.00 hour................        7,040.00       548,486.40
     occupational illness (Form
     FRA F 6180.55a).
225.21--Railroad injury and         784 railroads............  9,408.00 forms...............  10.00 minutes............        1,568.00       122,162.88
 illness summary--Form FRA F
 6180.55.
225.21--Annual railroad report of   784 railroads............  784.00 forms.................  15.00 minutes............          196.00        15,270.36
 employee hours and casualties, by
 state--Form FRA F 6180.56.
225.21/25--Railroad employee        784 railroads............  4,000.00 forms...............  1.00 hour................        4,000.00       311,640.00
 injury and/or illness record--
 Form FRA F 6180.98.
    --Copies of forms to employees  784 railroads............  3.60 form copies.............  2.00 minutes.............            0.12             9.35
225.21--Initial rail equipment      784 railroads............  10,194.00 forms..............  30.00 minutes............        5,097.00       397,107.27
 accident/incident record--Form
 FRA F 6180.97.
                                   ---------------------------------------------------------------------------------------------------------------------
    --Completion of Form FRA F      FRA anticipates zero railroad submissions during this 3-year ICR period.
     6180.97 because of rail
     equipment involvement.
                                   ---------------------------------------------------------------------------------------------------------------------
    --Alternative record for        784 railroads............  150.00 forms.................  75.00 minutes............          187.50        14,608.13
     illnesses claimed to be work
     related--Form FRA F 6180.107.
    --Highway User Statement--RR    784 railroads............  721.00 letters/forms.........  50.00 minutes............          600.83        46,810.67
     cover letter and Form FRA F
     6180.150 sent out to
     potentially injured travelers
     involved in a highway-rail
     grade crossing accident/
     incident.
    --Form FRA F 6180.150           117 injured individuals..  117.00 forms.................  45.00 minutes............           87.75         6,836.60
     completed by highway user and
     sent back to railroad.
225.25(h)--Posting of monthly       784 railroads............  9,408.00 lists...............  5.00 minutes.............          784.00        61,081.44
 summary.
225.27(a)(1)--Retention of records  784 railroads............  7,500.00 records.............  2.00 minutes.............          250.00        19,477.50
                                   ---------------------------------------------------------------------------------------------------------------------
    --Record of Form FRA F          The estimated paperwork burden for this requirement is included in 225.21 (Alternative record for illnesses claimed
     6180.107s.                      to be work related).
                                   ---------------------------------------------------------------------------------------------------------------------
    --Record of Monthly Lists.....  784 railroads............  9,408.00 records.............  2.00 minutes.............          313.60        24,432.58
(a)(2)--Record of Form FRA F        784 railroads............  10,194.00 records............  2.00 minutes.............          339.80        26,473.82
 6180.97.
    --Record of employee human      784 railroads............  1,464.00 records.............  2.00 minutes.............           48.80         3,802.01
     factor attachments.
225.33--Internal Control Plans--    784 railroads............  10.00 amendments.............  6.00 hours...............           60.00         4,674.60
 Amendments.
225.35--Access to records and       784 railroads............  784.00 lists.................  20.00 minutes............          261.33        20,360.22
 reports.
                                   ---------------------------------------------------------------------------------------------------------------------
225.37(a)--Optical media transfer   FRA anticipates zero submissions during this 3-year ICR period.
 of reports, updates, and
 amendments.
                                   ---------------------------------------------------------------------------------------------------------------------
(c)(2)--Electronic submission of    784 railroads............  4,704.00 submissions.........  3.00 minutes.............          235.20        18,324.43
 reports, updates, and amendments.
                                   ---------------------------------------------------------------------------------------------------------------------
        Totals \5\................  784 railroads............  88,176 responses.............  N/A......................          30,284        2,359,310
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    Total Estimated Annual Responses: 88,176.
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    \4\ The dollar equivalent cost is derived from the 2021 Surface
Transportation Board Full Year Wage A&B data series using the
appropriate employee group hourly wage rage that includes a 75
percent overhead charge.
    \5\ Totals may not add due to rounding.
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    Total Estimated Annual Burden: 30,284 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
$2,359,310.
    FRA informs all interested parties that it may not conduct or
sponsor, and a respondent is not required to respond to, a collection
of information that does not display a currently valid OMB control
number.
    Authority: 44 U.S.C. 3501-3520.

Allison Ishihara Fultz,
Chief Counsel.
[FR Doc. 2023-15626 Filed 7-21-23; 8:45 am]
BILLING CODE 4910-06-P


DOE Departmental Directives Program
Types of Directives
Policies establish high level expectations in the conduct of the Department's mission impacting two or more Departmental elements. Policies do not contain requirements.  However, Orders and Notices that flow from Policies must be consistent with them.
Orders establish management objectives and requirements and assign responsibilities for DOE Federal employees consistent with policy and regulations. Requirements must be unique to DOE and must avoid duplicating information from other directives or any existing legal source. Responsibilities must impact at least two Departmental elements. The requirements identify the results needed in the performance of a job or a subject matter area.  Details on how to fulfill requirements can be appended or attached as appropriate. Orders may also establish intended requirements for contractors in the form of contractor requirements documents (CRDs).
Notices have the same effect as Orders but are issued in response to Departmental matters requiring prompt action to establish short-term management objectives.  A Notice of this nature must be converted to or incorporated into an Order within 1 year of the effective date. An extension may be granted through issuance of another Notice provided that work on converting the Notice to an Order is in progress or the Notice is being converted to a rule. A Notice may also establish intended requirements for contractors by attaching a CRD.  Additionally, a Notice can be used to communicate general information throughout the Department and may reference requirements from an existing directive. Notices of this nature are issued for immediate or short term use and also expire no later than 1 year from issuance.
Manuals supplement other directives, laws, and regulations, or other requirements by providing more instructions or details on how the provisions of these directives or laws must be carried out throughout DOE. Manuals identify procedural requirements in more detail than Orders for DOE Federal employees and intended requirements for contractors, which must be in the form of the CRD attached to the Manual.
Note: Manuals will remain in effect until revised according to DOE O 251.1C and will be phased out over time as a result of this Order.  When scheduled for renewal, they will be converted into appendices within Orders.
Guides provide acceptable, but not mandatory, means for complying with requirements of an Order or rule. Guides must not impose requirements but may quote requirements if the sources are adequately cited. Alternate methods may be used if it can be demonstrated that they provide equivalent or better level of performance.
 https://www.directives.doe.gov/directives/types-of-directives


[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Rules and Regulations]
[Pages 41834-41835]
[FR Doc No: C1-2023-11904]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 110 and 300

[EPA-HQ-OPA-2006-0090; FRL-4526-01-OLEM]
RIN 2050-AE87

National Oil and Hazardous Substances Pollution Contingency Plan;
Product Schedule Listing and Authorization of Use Requirements

Correction

    In rule document 2023-11904 beginning on page 38280 in the issue of
Monday, June 12, 2023 make the following corrections:

Appendix C to Part 300

    1. On page 38339, Equation 1 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.004

    2. On page 38340, Equation 2 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.005

    3. On the same page, Equation 3 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.006

    4. On page 38341, Equation 4 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.007

    5. On the same page, Equation 5 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.008

    6. On the same page, Equation 6 should read as follows:

[GRAPHIC] [TIFF OMITTED] TR28JN23.009

    7. On the same page, Equation 7 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.010

    8, On the same page, Equation 8 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.011

    9. On page 38342, Equation 9 and the first two words following it
should read as follows:
[GRAPHIC] [TIFF OMITTED] TR28JN23.012

where (%OD)

    10. On the same page, Equation 10 should read as follows:
    [GRAPHIC] [TIFF OMITTED] TR28JN23.013

[FR Doc. C1-2023-11904 Filed 6-27-23; 8:45 am]
BILLING CODE 0099-10-D


United States

Environmental Protection Agency

Office of Prevention, Pesticides and Toxic Substances

(7505P)

_______________________________________________________

Pesticide

Fact Sheet

Name of Chemical:	Mammalian Gonadotropin Releasing Hormone (GnRH)

Reason for Issuance:          New Chemical

                                             Nonfood Use

Date Issued:                        September 2009

_______________________________________________________

1. Description of Chemical

Peptide Chain:	pyroGlu1 -His2-Trp3- Ser4 -Tyr5- Gly6 -Leu7-Arg8-Pro9- G
ly10NH2 [GnRH]

Common Name:	Mammalian Gonadotropin Releasing Hormone (GnRH)

EPA PC Code:		      116800

Chemical Abstracts

Service (CAS) Number:		9034-40-6

Chemical Class:			Sterilant/Hormone

Registration Status:			New Chemical, nonfood use

Pesticide Type:			Mammalian Contraceptive

U.S. Producer:	U.S. Department of Agriculture, APHIS, Pocatello Supply
Depot

	238 East Dillon Street

	Pocatello, ID 83201

2. Use Pattern and Formulations

Mode of Action	The active ingredient, Mammalian Gonadotropin Releasing
               Hormone (GnRH) is conjugated into a large protein that
initiates an immune response in the animal with its own GnRH resulting
in contraceptive effects for a minimum of one year.

Application Sites			GonaCon will be used to control wild white-tailed
deer Odocoileus virginianus) populations in areas where they have become
a nuisance (e.g, urban and suburban settings).

Methods of

Application 				The vaccine will be administered to restrained female
deer using preloaded syringes with an 18 or 19 gauge stainless steel
hypodermic needle intramuscularly into a large muscle mass by hand
injection only.

							GonaCon is classified as a Restricted Use Pesticide.  Use is
restricted to USDA APHIS Wildlife Services or state wildlife management
personnel or persons working under their authority.

Application Rate:			Female deer are injected with a single injection
containing 1.0 ml of GonaCon at least two to three months prior to the
onset of rut for full contraceptive effect. If multi year contraceptive
effects are desired, a second vaccination may be given 30 to 60 days
after the first injection or during the following year.

							Two formulations (basic and alternate) are proposed for
registration.

3. Science Findings

Available data supporting the use and registration of Mammalian
Gonadotropin Releasing Hormone including product chemistry, toxicology,
efficacy, and ecological effects and environmental fate are summarized
below.

Common name	Mammalian Gonadotropin Releasing Hormone (GnRH)

CAS Reg. No.	9034-40-6

Color	white

Physical State	Active: solid:  powder

EU:  liquid: somewhat creamy in appearance

Melting Point	N/A Waiver request

Boiling Point	Waiver request: Solid at room temperature.

Odor	Active:  odorless

EU:  odorless

Stability to Normal and Elevated Temperatures, Metal, and Metal Ions	N/A
Waiver request

Oxidation/Reduction Action	N/A Waiver request

pH	Active:  NA

EU: pH = 6.49

Flammability	N/A Waiver request

Explodability	N/A Waiver request

Vapor pressure	N/A Waiver request

Water Solubility	N/A Waiver request

Storage stability	N/A product’s shelf life will be < 6 months so not
necessary

Corrosion Characteristics	N/A product’s shelf life will be < 6 months
so not necessary

TOXICOLOGY SUMMARY

The Registrant submitted the studies listed in Tables 2, which include a
number of toxicity studies. The Registrant submitted waiver requests
which were granted for acute inhalation and dermal sensitization.

Acute Toxicity Data GnRH

Table 2.  Acute Toxicity

Guideline

No.

Study Type

Results	Toxicity Category*

OPPTS

870.1100	Acute Oral

Rat	All test animals survived 1 mL exposure.

IV

OPPTS

870.1200	Acute Dermal

Rat	All test animals survived 1 mL exposure.

IV

OPPTS

870.1300	Acute Inhalation

Rat	WAIVED

IV

OPPTS

870.2400	Primary Eye Irritation

Rabbit	No corneal opacity or iritis was observed.  1-hour
post-instillation: 3/3 treated eyes exhibited conjunctival redness
(score 1-2) and discharge (score 1).  No “positive” grade irritation
was noted at the 24-hour observation.  Treated eyes were free of all eye
irritation by 72-hours.

IV

OPPTS

870.2500	Primary Skin Irritation

Rabbit	No edema was observed at any treated site.  Very slight erythema
(score 1) was noted at all 3/3 test sites within 1-hour post-pad
removal.  Irritation severity decreased thereafter.  No irritation was
noted at the 72-hour observation.  The PDII was 0.5.

IV

OPPTS

870.2600	Dermal sensitization

	WAIVED

--

Toxicity Category IV = No precautions required

Chronic toxicity data requirements were waived.  There is no human
exposure from use of GonaCon, therefore no toxicity endpoints were
selected because of the very limited potential worker and dietary
exposure.

ECOLOGICAL EFFECTS

Waivers were submitted to fulfill required ecological effects and
environmental fate guideline studies for the registration of GonaCon
because of the limited potential for environmental releases.  Since the
product is labeled only for injection to deer by hand and the substance
is expected to be rapidly metabolized in treated animals, the limited
potential risks to non-target organisms resulting from the proposed
registration of GonaCon are not expected to exceed the Agency’s
concern levels.

The proposed registration of GonaCon is expected to have no effect on
endangered or threatened species

EFFICACY

GonaCon is intended to render a vaccinated female white-tailed deer
infertile for a minimum of one year following vaccination. The label
claims that GonaCon will not affect existing pregnancies but should
cause infertility of the vaccinated animal in subsequent years. If
multi-year contraceptive effects are desired, a second vaccination may
be given 30-60 days after the first injection or during the following
year. The label claims that there is a chance that some vaccinated
females will become permanently sterile.

Product performance studies were conducted by APHIS’s National
Wildlife Research Center (NWRC) both in the field over a two year period
and in a laboratory over multiple years to compare two different
formulations.

The field test, initiated in 2004 used two sites consisting of fenced
federal land near Silver Spring, MD. Female deer in the vaccinated group
were dosed with the labeled rate of the vaccine during July and August
2004. All deer were marked with ear tags and radio telemetry collars
equipped with mortality sensors. Reproductive status was assessed in the
summers of 2005 and 2006 with visual inspection of the udders for signs
of lactation.

Results showed 88% efficacy in the summer after vaccination with
lactation evident in 3 of the 26 does vaccinated (12%). Of the control
group, reproductive status was able to be determined in 13 of the 15
deer and lactation was evident in 11 of those 13 doe (85%).

In the second summer after vaccination lactation was evident in 10 of
the remaining 19 vaccinated deer (53%) equating to an efficacy rate of
47%. In the control group, 10 of the 10 remaining deer (100%) had
reproductive success.

The lab study results showed the alternate formulation to be more
effective than the basic formulation. The alternate formulation had a
100% success rate (5/5 does remained contracepted for two years)
compared to the basic formulation with a 60% success rate after two
years (3/5 does contracepted). Due to economic and supply reasons
however, it is necessary for the product to carry both formulations.

4. Summary of Regulatory Position and Rationale

Available data provide adequate information to support the conditional
registration of GnRH as an effective population control method for
nuisance white-tailed deer.

White-tailed deer have been classified by EPA as a public health pest
because they are a host for deer ticks that may cause Lyme disease and
they are a cause of vehicle accidents.  In many urban and suburban areas
white-tailed deer populations have become over abundant and are
considered a year-round nuisance causing many human-wildlife conflicts.
Since these areas are typically non hunting areas, where building and
population densities do not allow for safe shooting zones, local laws
prohibit guns or shooting or public opinion does not support hunting,
there has not been an economically feasible solution to control
overabundant deer populations.

In many of these urban and suburban areas, deer have been known to
inflict significant economic damage to gardens and landscapes of
homeowners associations, golf courses, private residential yards, etc.
When deer are in numbers exceeding 20 per square mile, as they are
becoming in many areas, they can inflict severe damage to resident flora
and fauna. This can adversely affect the ecosystem and the wildlife that
depend on that ecosystem.

Since deer in these areas are so well fed, female deer, which normally
give birth to twins may be becoming more fertile which is evident by an
increase in triplet births. This, and the fact that deer in developed
areas appear to be more nocturnal to avoid human contact, is
contributing to rapidly increasing populations and problems.

According to a 2006 study, the National Highway Traffic Safety
Administration reported that there are about 1.5 million car accidents
with deer resulting in over $1 billion of damage and 150 human
fatalities annually. GnRH will not only help prevent increases in deer
numbers through contraception, but should decrease the number of car
accidents during the fall mating season - which is associated with a
surge in car collisions with deer as bucks chase fertile does, sometimes
for miles.

Deer can also play a role in spreading disease as they are a main host
for blacklegged ticks (Ixodes scapularis), more commonly known as deer
ticks, which are a carrier of Lyme disease. There has been a sharp
increase in cases of Lyme disease in suburban/urban areas with
significant deer populations.

Contraception of nuisance deer using GnRH is not intended to replace
hunting (where it is an option) as a population control method. GnRH is
intended to be used in combination with other population management
techniques since it cannot alone reduce already over abundant
populations. Since GnRH is a nonlethal alternative to population
control, many animal rights groups enthusiastically support this
registration.

The registration of GonaCon has received letters of support from the
Department of Natural Resources at Cornell University and White Buffalo,
Inc. a non-profit wildlife organization based out of Connecticut. At
Cornell University, deer have caused damages to plants in research and
teaching plots as well as dozens of car accidents. Currently, the
university attempts population management of deer by capturing and
surgically sterilizing deer via tubal ligation. This method however is
both time consuming and costly, with expenses of approximately $1,000
per deer along with the impracticality of finding surgery staff and
anesthesiologists during the early and late hours that deer are
typically captured.   The use of GnRH is also supported by the Humane
Society of the United States as a humane and “necessary” method of
deer population control.

GonaCon was mentioned in an April 2009 article in the Washington Post
Magazine as a possible population control method for deer in Rock Creek
Park in Washington, DC and suburban Maryland.

5. Labeling Restrictions

To mitigate any risks, the following requirements have been imposed:

Restricted -Use Pesticide classification due to non-target injection
hazard.

Application is restricted to USDA APHIS Wildlife Services or state
wildlife management agency personnel or persons working under their
authority only.

Administration of vaccine is only by hand injection to mitigate any
non-target or environmental risks that occur with administration with
darts.

Use restricted to only one species: white-tailed deer (Odocoileus
virginianus).

PPE requirements include: long sleeved shirt and long pants, gloves and
shoes plus socks to mitigate occupational exposure.

Children are not allowed in areas where product is used

A warning that pregnant women should not be involved in handling or
injecting GonaCon and that all women should be aware that accidental
self-injection may cause infertility.

6. Conditional Data Requirements

Because of the unique chemical nature of GnRH additional preliminary
analysis and certified limits data are necessary.  The registrant must
submit this data to the Agency upon completion.

Conditional data required for GonaCon consists of:

Guideline 830.1700 Validating the method of analysis of the formulation
and additional preliminary analysis

Guideline 830.1750 Certified Limits

Contact Person at USEPA

Mailing address:

Autumn Metzger

Biologist, Insecticide-Rodenticide Branch

Environmental Protection Agency

Office of Pesticide Programs

Registration Division (7505P)

Insecticide Branch

1200 Pennsylvania Avenue NW

Washington, D.C. 20460

Office location and telephone number:

Room S-7224, One Potomac Yard

2777 S. Crystal Drive

Arlington, VA 22202

703-305-5314

DISCLAIMER: The information in this Pesticide Fact Sheet is for
information only and is not to be used to satisfy data requirements for
pesticide registration. The information is believed to be accurate as of
the date on the document.

APPENDIX I

GLOSSARY OF TERMS AND ABBREVIATIONS

ADNT	Acute delayed neurotoxicity

a.i.	Active Ingredient

aPAD	Acute Population Adjusted Dose

ARI	Aggregate Risk Index

BCF	Bioconcentration Factor

CAS	Chemical Abstracts Service

ChE	Cholinesterase

ChEI	Cholinesterase inhibition

cPAD	Chronic Population Adjusted Dose

%CT	Percent crop treated

DAT	Days after treatment

DEEM-FCID	Dietary Exposure Evaluation Model - Food Consumption Intake
Database

DNA	Deoxyribonucleic acid

DNT	Developmental neurotoxicity

DIT	Developmental immunotoxicity

DWLOC  	Drinking Water Level of Comparison.

EC	Emulsifiable Concentrate Formulation

EEC		Estimated Environmental Concentration. The estimated pesticide
concentration in an environment, such as a terrestrial ecosystem.

EPA	U.S. Environmental Protection Agency

FQPA	Food Quality Protection Act

GLC	Gas Liquid Chromatography

GLN	Guideline Number

LC50   	Median Lethal Concentration. A statistically derived
concentration of a substance that can be expected to cause death in 50%
of test animals. It is usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD50  	Median Lethal Dose. A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOAEL	Lowest Observed Adverse Effect Level

LOAEC	Lowest Observed Adverse Effect Concentration

LOC	Level of Concern

LOD	Limit of Detection

LOQ	Limit of Quantitation

mg/kg/day	Milligram Per Kilogram Per Day

mg/L	Milligrams Per Liter

MOE	Margin of Exposure

MRID	Master Record Identification (number), EPA's system of recording
and tracking studies submitted

MTD	Maximum tolerated dose

NA	Not Applicable

NOEC	No Observable Effect Concentration

NOEL	No Observed Effect Level

NOAEL	No Observed Adverse Effect Level

NOAEC	No Observed Adverse Effect Concentration

NPDES	National Pollutant Discharge Elimination System

OP	Organophosphate

OPP	EPA Office of Pesticide Programs

OPPTS	EPA Office of Prevention, Pesticides and Toxic Substances

PAD	Population Adjusted Dose

PAG	Pesticide Assessment Guideline

PAM	Pesticide Analytical Method

PHED	Pesticide Handler's Exposure Data

PHI	Preharvest Interval

ppb	Parts Per Billion

PPE	Personal Protective Equipment

ppm	Parts Per Million

PRZM/EXAMS	 Tier II Surface Water Computer Model

RAC  	Raw Agriculture Commodity

RBC	Red Blood Cell

RED	Reregistration Eligibility Decision

REI	Restricted Entry Interval

RfD	Reference Dose

SCI-GROW	Tier I Ground Water Computer Model

SF	Safety Factor

TGAI	Technical Grade Active Ingredient

UF	Uncertainty Factor

µg	micrograms

µg/L	Micrograms Per Liter

µL/g	Microliter per gram

USDA	United States Department of Agriculture

WPS	Worker Protection Standard APPENDIX II

Citations Considered Part of the Data Base Supporting the Registration
of GonaCon.

  HYPERLINK "JavaScript:sortUpdate(document.sort,'1')"  MRID
HYPERLINK "JavaScript:sortUpdate(document.sort,'2')"  Citation 	Receipt
Date

47649600	United States Department of Agriculture's Animal and Plant
Health Inspection Service (USDA APHIS) (2009) Submission of Product
Chemistry, Toxicity, Efficacy and Residue Data in Support of the
Application for Registration of GonaCon Immunocontraceptive Vaccine.
Transmittal of 36 Studies.	22-Jan-2009

47649601	O'Hare, J.; Eisemann, J. (2008) Description of Materials Used
to Produce: "GoneCon Immunocontraceptive Vaccine". Project Number:
P4417. Unpublished study prepared by US Dept. of Agriculture, APHIS, WS:
National Wildlife Research Center. 168 p.	22-Jan-2009

47649602	O'Hare, J.; Eisemann, J. (2008) Description of Formulation
Process Used to Manufacture: "GonaCon Immunocontraceptive Vaccine".
Project Number: M8546, BT016/02. Unpublished study prepared by US Dept.
of Agriculture, APHIS, WS: National Wildlife Research Center. 99 p.
22-Jan-2009

47649603	O'Hare, J.; Pilon, J.; Eisemann, J. (2008) Discussion of the
Formation of Impurities "GonaCon Immunocontraceptive Vaccine".
Unpublished study prepared by US Dept. of Agriculture, APHIS, WS:
National Wildlive Research Center. 56 p.	22-Jan-2009

47649604	O'Hare, J.; Eisemann, J.; Pilon, J. (2008) Preliminary Analysis
and Certified Limits "GonaCon Immunocontraceptive Vaccine": Final
Report. Unpublished study prepared by US Dept. of Agriculture, APHIS,
WS: National Wildlife Research Center. 9 p.	22-Jan-2009

47649605	O'Hare, J.; Eisemann, J. (2008) Enforcement Analytical Method:
"GonaCon Immunocontraceptive Vaccine". Unpublished study prepared by US
Dept. of Agriculture, APHIS, WS: National Wildlife Research Center. 40
p.	22-Jan-2009

47649606	O'Hare, J.; Eisemann, J. (2007) Product Chemistry: Color,
Physical State, Odor, and pH - USDA APHIS GonaCon Immunocontraceptive
Vaccine (EPA Reg. No. 56228-xx): Final Report. Project Number: QA/1421.
Unpublished study prepared by US Dept. of Agriculture, APHIS, WS:
National Wildlife Research Center. 31 p.	22-Jan-2009

47649607	Warren, J.; Stephens, S. (2008) Stability to Normal and
Elevated Temperatures, Metal, and Metal Ions: (Gonadotropin Releasing
Hormone). Unpublished study prepared by US Dept. of Agriculture, APHIS,
WS. 8 p.	22-Jan-2009

47649608	Warren, J.; Stephens, S. (2008) Oxidation/Reduction Chemical
Incompatibility: (GonaCon Immunocontraceptive Vaccine). Unpublished
study prepared by US Dept. of Agriculture, APHIS, WS. 8 p.	22-Jan-2009

47649609	Warren, J.; Stephens, S. (2008) Flammability: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
8 p.	22-Jan-2009

47649610	Warren, J.; Stephens, S. (2008) Explodability: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
4 p.	22-Jan-2009

47649611	Warren, J.; Stephens, S. (2008) Miscibility: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
8 p.	22-Jan-2009

47649612	Warren, J.; Stephens, S. (2008) Corrosion Characteristics:
(GonaCon Immunocontraceptive Vaccine). Unpublished study prepared by
USDA APHIS. 8 p.	22-Jan-2009

47649613	Warren, J.; Stephens, S. (2008) Dielectric Breakdown Voltage:
(GonaCon Immunocontraceptive Vaccine). Unpublished study prepared by
USDA APHIS. 8 p.	22-Jan-2009

47649614	Warren, J.; Stephens, S. (2008) UV/Visible Absorption: (GonaCon
Immunocontraceptive). Unpublished study prepared by USDA APHIS. 8 p.
22-Jan-2009

47649615	Warren, J.; Stephens, S. (2008) Viscosity: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
8 p.	22-Jan-2009

47649616	Warren, J.; Stephens, S. (2008) Melting Point: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
8 p.	22-Jan-2009

47649617	Warren, J.; Stephens, S. (2008) Boiling Point: (GonoCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
4 p.	22-Jan-2009

47649618	Warren, J.; Stephens, S. (2008) Density/Relative Density/Bulk
Density: (GonaCon Immunocontraceptive Vaccine). Unpublished study
prepared by USDA APHIS. 4 p.	22-Jan-2009

47649619	Warren, J.; Stephens, S. (2008) Dissociation Constant in Water:
(GonaCon Immunocontraceptive Vaccine). Unpublished study prepared by
USDA APHIS. 8 p.	22-Jan-2009

47649620	Warren, J.; Stephens, S. (2008) Octanol/Water Partition
Coefficient: (GonaCon Immunocontraceptive Vaccine). Unpublished study
prepared by USDA APHIS. 8 p.	22-Jan-2009

47649621	Warren, J.; Stephens, S. (2008) Water Solubility: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
8 p.	22-Jan-2009

47649622	Warren, J.; Stephens, S. (2008) Vapour Pressure: (GonaCon
Immunocontraceptive Vaccine). Unpublished study prepared by USDA APHIS.
8 p.	22-Jan-2009

47649623	Eisemann, J.; O'Hare, J. (2008) Chemical Identity: "GonaCon
Immunocontraceptive Vaccine". Unpublished study prepared by US Dept. of
Agriculture, APHIS, WS: Natiional Wildlife Research Center. 27 p.
22-Jan-2009

47649624	Eisemann, J.; O'Hare, J. (2008) Direction for Use: GonaCon
Immunocontraceptive Vaccine. Unpublished study prepared by US Dept. of
Agriculture, APHIS, WS: National Research Center. 12 p.	22-Jan-2009

47649625	Lowe, C. (2008) GonaCon Immunocontraceptive Vaccine: Acute Oral
Toxicity - Limit Dose Procedure in Rats. Project Number: P320/USDA,
23211. Unpublished study prepared by Product Safety Laboratories. 28 p.
22-Jan-2009

47649626	Lowe, C. (2008) GonaCon Immunocontraceptive Vaccine: Acute
Dermal Toxicity - Limit Dose Procedure in Rats. Project Number: 23212,
P322/USDA. Unpublished study prepared by Product Safety Laboratories. 28
p.	22-Jan-2009

47649627	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Acute Inhalation
Toxicity: (GonaCon Immunocontraceptive Vaccine). Unpublished study
prepared by USDA APHIS. 4 p.	22-Jan-2009

47649628	Lowe, C. (2007) GonaCon Immunocontraceptive Vaccine: Primary
Eye Irritation Study in Rabbits. Project Number: P324, 22806.
Unpublished study prepared by Product Safety Laboratories. 29 p.
22-Jan-2009

47649629	Lowe, C. (2008) GonaCon Immunocontraceptive Vaccine: Primary
Skin Irritation Study in Rabbits. Project Number: P326, 22807.
Unpublished study prepared by Product Safety Laboratories. 27 p.
22-Jan-2009

47649630	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Dermal
Sensitization: (GonaCon Immunocontraceptive Vaccine). Unpublished study
prepared by USDA APHIS. 4 p.	22-Jan-2009

47649631	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Chronic Dietary
Toxicity: (GonaCon Immunocontraceptive Vaccine). Unpublished study
prepared by USDA APHIS. 4 p.	22-Jan-2009

47649632	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Gene Mutation:
(GonaCon Immunocontraceptive Vaccine): (Human). Unpublished study
prepared by USDA APHIS. 4 p.	22-Jan-2009

47649633	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Stuctural
Chromosomal Aberration: (GonaCon Immunocontraceptive Vaccine): (Human).
Unpublished study prepared by USDA APHIS. 4 p.	22-Jan-2009

47649634	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Other Genotoxic
Effects: (GonaCon Immunocontraceptive Vaccine): (Human). Unpublished
study prepared by USDA APHIS. 4 p.	22-Jan-2009

47649635	O'Hare, J.; Eisemann, J.; Stephens, S. (2008) Acute Delayed
Neurotoxicity: (GonaCon Immunocontraceptive Vaccine): (Hen). Unpublished
study prepared by USDA APHIS. 4 p.	22-Jan-2009

47649636	Gionfriddo, J.; Eisemann, J.; O'Hare, J. (2008) Product
Performance: Field Test of a Single-Injection of GonaCon
Immunocontraceptive Vaccine In Female White-Tailed Deer. Project Number:
QA/1112. Unpublished study prepared by US Dept. of Agriculture, APHIS,
WS: National Wildlife Research Center. 31 p.	22-Jan-2009

 PAGE

 PAGE   7


[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Notices]
[Pages 30738-30740]
[FR Doc No: 2020-10829]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0042]

Gear Certification Standard; Revision 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 comments.

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

SUMMARY: OSHA solicits public comments concerning the proposal to
extend the Office of Management and Budget (OMB) approval of the
information collection requirements specified in the Gear Certification
Standard.

DATES: Comments must be submitted (postmarked, sent, or received) by
July 20, 2020.

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 a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2010-0042, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Docket Office's normal business hours, 10:00 a.m.
to 3:00 p.m., ET.
    Instructions: All submissions must include the agency name and the
OSHA docket number (OSHA-2010-0042) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, such as social security numbers and dates of birth, 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 above address. 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 from the website. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney or
Seleda Perryman at the below phone number to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Seleda Perryman,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of the 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 (PRA) (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 to reduce
to the maximum extent feasible unnecessary duplication of effort in
obtaining information (29 U.S.C. 657).
    The ICR addresses the burden hours associated with gathering
information to complete the OSHA 70 Form. The OSHA 70 Form is used by
applicants seeking accreditation from OSHA to be able to test or
examine certain equipment and material handling devices as required
under the maritime regulations, part 1917 (Marine Terminals), and part
1918 (Longshoring). The OSHA 70 Form application for accreditation
provides an easy means for companies to apply for accreditation.

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

    The agency is requesting an adjustment decrease of 94 hours (from
203 to 109 hours) associated with this Information Collection Request.
The decrease is primarily attributed to a decline in the issuance of
exams from 8,701 to 5,000 and the number of applicants seeking
accreditation from 39 to 35. The agency determined that it had over
counted the number of quadrennial exams since they are conducted every
4 years rather than annually. Additionally, the cost to the government
was not factored in during previous years. This new program change
factors in the Cost of the Government to run this program.
    Type of Review: Revision of a currently approved collection.
    Title: Gear Certification Standard (29 CFR part 1919); OSHA 70
Form.
    OMB Control Number: 1218-0003.
    Affected Public: Business or other for-profits.
    Number of Respondents: 664.
    Frequency of Responses: On occasion; Monthly; Quadrenially.
    Total Responses: 5,035.
    Average Time per Response: Varies from one minute (1/60 hour) for a
clerical to maintain certifications to 45 minutes (45/60 hour) for a
prospective accredited agency to complete the OSHA 70 Form.
    Estimated Total Burden Hours: 109.
    Estimated Cost (Operation and Maintenance): $2,612,500.

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 the OSHA docket number for this ICR (Docket No. OSHA-2010-0042).
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
dates 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 from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
    Contact the OSHA Docket Office for information about materials not
available from the website, and for assistance in using the internet to
locate docket submissions.

V. Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor
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. 1-2012 (77 FR
3912).

    Signed at Washington, DC.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-10829 Filed 5-19-20; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15359-15361]
[FR Doc No: 2017-06078]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0932]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study on Warning Statements for Cigarette
Graphic Health Warnings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings that is being
conducted in support of the graphic label statement provision of the
Family Smoking Prevention and Tobacco Control Act (the Tobacco Control
Act).

DATES: Submit either electronic or written comments on the collection
of information by May 30, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-0932 for ``Agency Information Collection Activities,
Proposed Collection; Comment Request; Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

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

Experimental Study on Warning Statements for Cigarette Graphic Health
Warnings

OMB Control Number--0910-New

    The health risks associated with the use of cigarettes can be
significant and far-reaching. In 2009, Congress enacted the Tobacco
Control Act (Pub. L. 111-31), which amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
the public health and to reduce tobacco use by minors. Section 201 of
the Tobacco Control Act amends section 4 of the Federal Cigarette
Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require FDA to
issue ``regulations that require color graphics depicting the negative
health consequences of smoking to accompany the label statements
specified in subsection (a)(1).'' Section 202(b) of the Tobacco Control
Act further amends section 4 the FCLAA by adding that the Secretary,
through notice and comment rulemaking, may adjust the ``text of any of
the label requirements . . . if the Secretary finds that such a change
would promote greater public understanding of the risks associated with
the use of tobacco products.''
    In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued
a final rule entitled ``Required Warnings for Cigarette Packages and
Advertisements,'' which specified nine images to accompany the new
textual warning statements for cigarettes. Although the rule was
scheduled to become effective 15 months after it issued, a panel of the
U.S. Court of Appeals of the District of Columbia held, on August 24,
2012, that the rule in its current form violated the First Amendment.
In a letter to Congress on March 15, 2013, the Attorney General
reported FDA's intention to undertake research to support a new
rulemaking consistent with the Tobacco Control Act. Preliminary
research has been underway since 2013. Informed by the previous court
decisions on this matter, including on the First Amendment, the next
phase of the research includes the study proposed here, which is an
effort by FDA to collect data concerning revised textual warning
statements for use with new images as part of cigarette graphic health
warnings, and their potential impact on public understanding of the
risks associated with the use of cigarettes.
    As currently proposed, this Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings is a voluntary online
experiment conducted with consumers. The purpose of the proposed study
is to assess whether potential textual warnings statements, which have
been revised from those enumerated in section 4 of FCLAA, promote
greater public understanding of the negative health consequences of
cigarette smoking. The study will collect data from various groups of
consumers, including adolescent (under age 18) current cigarette
smokers, adolescents who are susceptible to initiation of cigarette
smoking, young adult (ages 18- to 24) current cigarette smokers, and
older adult (ages 25 and above) current cigarette smokers. The results
will inform the Agency's development of cigarette graphic health
warnings to be tested in future studies with the goal of implementing
the mandatory graphic warning label statement consistent with section
4(d) of FCLAA and the First Amendment.
    Proposed Study Overview: In this study, adolescent current
cigarette smokers, adolescents who are susceptible to initiation of
cigarette smoking, young adult current cigarette smokers, and older
adult current smokers will be recruited from an Internet panel of more
than 1.2 million people and screened for inclusion into the study.
Participants who meet the inclusion criteria will be randomized into
one of 17 conditions in a between-subjects design. In each condition,
participants will be exposed to a series of nine warning statements,
presented sequentially. Participants randomized to the control
condition will view all nine of the warning statements listed in
section 4(a)(1) of FCLAA:

 WARNING: Cigarettes are addictive.
 WARNING: Tobacco smoke can harm your children.
 WARNING: Cigarettes cause fatal lung disease.
 WARNING: Cigarettes cause cancer.
 WARNING: Cigarettes cause strokes and heart disease.
 WARNING: Smoking during pregnancy can harm your baby.
 WARNING: Smoking can kill you.
 WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
 WARNING: Quitting smoking now greatly reduces serious risks to
your health.

    Participants randomized to 1 of the 16 experimental conditions will
view 8 of the warning statements listed in section 4(a)(1) of FCLAA
(above) plus 1 statement that is a revised version of a statutory text
warning. The revised warning statements being tested in this proposed
study are:

 WARNING: Smoking causes mouth and throat cancer.
 WARNING: Smoking causes head and neck cancer.
 WARNING: Smoking causes bladder cancer, which can lead to
bloody urine.
 WARNING: Smoking during pregnancy causes premature birth.
 WARNING: Smoking during pregnancy stunts fetal growth.
 WARNING: Smoking during pregnancy causes premature birth and
low birth weight.
 WARNING: Secondhand smoke causes respiratory illnesses in
children, like pneumonia.
 WARNING: Smoking can cause heart disease and strokes by
clogging arteries.
 WARNING: Smoking causes COPD, a lung disease that can be
fatal.
 WARNING: Smoking causes serious lung diseases like emphysema
and chronic bronchitis.
 WARNING: Smoking reduces blood flow, which can cause erectile
dysfunction.
 WARNING: Smoking reduces blood flow to the limbs, which can
require amputation.
 WARNING: Smoking raises blood sugar, which can cause type 2
diabetes.
 WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness.
 WARNING: Smoking causes cataracts, which can lead to
blindness.

    In all conditions, after viewing each statement, participants will
respond to a small number of questions about that specific statement.
Following viewing all nine statements, participants will respond to a
larger set of questions. Next, participants will view an additional
nine revised warning statements, drawn from the revised statements
listed above, and respond to an additional set of questions. Primary
study outcomes include beliefs and knowledge of the negative health
consequences of cigarette smoking. Prior to the main data collection,
two pretests, each with 50 participants, will take place to ensure
correct programming and to identify any issues with the proposed study
design and implementation.
    Estimated Burden: FDA estimates the burden of this collection of
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
       Portion of study            Number of    responses  per   Total  annual   Average  burden    Total hours
                                  respondents      respondent      responses      per  response
----------------------------------------------------------------------------------------------------------------
Screening for pretest.........             762               1             762  .033 (2 minutes)              25
Pretest.......................             100               1             100  .25 (15 minutes)              25
Screening for main data                 19,082               1          19,082  .033 (2 minutes)             630
 collection.
Main data collection..........           2,500               1           2,500  .25 (15 minutes)             625
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................           1,305
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's burden estimate is based on prior experience with research
that is similar to this proposed study. Screening potential
participants for the 2 pretests will occur with 762 respondents (487
adults and 275 adolescents) identified and recruited through the
Internet panel. This brief screening will take an average of 2 minutes
(0.033 hours) per respondent. Each of the 2 pretests will consist of 50
respondents (34 adults and 16 adolescents) conducted during a single
session and take an average of 15 minutes (0.25 hours) per respondent.
Screening potential participants for the main data collection will
occur with 19,082 respondents (11,925 adults and 7,157 adolescents)
identified and recruited through the same Internet panel as used for
the pretests. This brief screening will take an average of 2 minutes
(0.033 hours) per respondent. Recent national estimates of the numbers
of adolescent current cigarette smokers, adolescents who are
susceptible to initiation of cigarette smoking, young adult current
cigarette smokers, and older adult current cigarette smokers informed
the estimates of 13.9 percent qualification rate for adults and 11.6
percent qualification rate for adolescents. Applying these estimates
and other assumptions from previous experience conducting similar
studies to the number of adolescents and adults to be screened results
in the desired sample size for the main data collection of 2,500
participants, of which 1,667 will be adults and 833 will be
adolescents. The main data collection will occur with those 2,500
respondents during a single session. The main data collection will take
an average of 15 minutes (0.25 hours) per respondent. The total
estimated burden is 1,305 hours (25 hours + 25 hours + 630 hours + 625
hours).

    Dated: March 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-06078 Filed 3-27-17; 8:45 am]
 BILLING CODE 4164-01-P


NCS Herald Cohort Study Instrument # 25 Mental Health and Financial Security Self Administered Questionnaire for Females 6 Month Visit Eligibility: All women who gave birth Mode of administration: Self administered, take home 8/ 4/ 2005 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Dr. Pauline Mendola, US EPA, MD 58A, Research Triangle Park, NC 27711. E mail: mendola. pauline@ epa. gov. Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

1 SECTION A. MOS For this section, please think about the past month.

A. 1. How many relatives do you have that you feel close to people you feel comfortable with, can talk with about personal things, or can ask for help if you need it? ( Include your husband, parents, children and other relatives.)

_____ relatives A. 2. How many close friends do you have that you feel close to people you feel comfortable with, can talk with about personal things, or can ask for help if you need it?

_____ friends People sometimes look to others for companionship, assistance, or other types of support. Please circle one number to indicate how often you feel each of the following kinds of support has been available to you if you needed it. Remember to think about how you have felt during the past month.

DURING THE PAST MONTH, HOW OFTEN WAS THIS SUPPORT AVAILABLE TO YOU: rarely or none of the time a little of the time some of the time most of the time all of the time A. 3. Someone to help me if I were confined to bed 1 2 3 4 5 A. 4. Someone I could count on to listen to me when I need to talk 1 2 3 4 5 A. 5. Someone to give me good advice about a crisis 1 2 3 4 5 A. 6. Someone to take me to the doctor if I needed it 1 2 3 4 5 A. 7. Someone who shows me love and affection 1 2 3 4 5 A. 8. Someone to have a good time with 1 2 3 4 5 Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

2 DURING THE PAST MONTH, HOW OFTEN WAS THIS SUPPORT AVAILABLE TO YOU: rarely or none of the time a little of the time some of the time most of the time all of the time A. 9. Someone to give me information to help me understand a situation 1 2 3 4 5 A. 10. Someone to confide in or talk to about myself or my problems 1 2 3 4 5 A. 11. Someone who hugs me 1 2 3 4 5 A. 12. Someone to get together with for relaxation 1 2 3 4 5 A. 13. Someone to prepare my meals if I were unable to do it myself 1 2 3 4 5 A. 14. Someone whose advice I really want 1 2 3 4 5 A. 15. Someone to do things with to help me get my mind off things 1 2 3 4 5 A. 16. Someone to help with daily chores if I were sick 1 2 3 4 5 A. 17. Someone to share my most private worries and fears with 1 2 3 4 5 A. 18. Someone to turn to for suggestions about how to deal with a personal problem 1 2 3 4 5 A. 19. Someone to do something enjoyable with 1 2 3 4 5 A. 20. Someone who understands my problems 1 2 3 4 5 A. 21. Someone to love and make me feel wanted 1 2 3 4 5 Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

3 SECTION B. CESD For this section, please think about the past week.

Below is a list of some of the ways you may have felt or behaved. Please indicate how often you have felt this way during the past week by circling one number for each item.

DURING THE PAST WEEK, HOW OFTEN DID YOU FEEL THIS WAY? rarely or none of the time ( less than one day) some or a little of the time ( 1 2 days) occasionally or moderate amount of time ( 3 4 days) most or all of the time ( 5 7 days)

B. 1. I was bothered by things that didn't usually bother me. 1 2 3 4 B. 2. I did not feel like eating; my appetite was poor. 1 2 3 4 B. 3. I felt that I could not shake off the blues even with help from my family and friends. 1 2 3 4 B. 4. I felt that I was just as good as other people. 1 2 3 4 B. 5 I felt I had trouble keeping my mind on what I was doing. 1 2 3 4 B. 6. I felt depressed. 1 2 3 4 B. 7 I felt that everything I did was an effort. 1 2 3 4 B. 8. I felt hopeful about the future. 1 2 3 4 B. 9 I thought my life had been a failure. 1 2 3 4 B. 10. I felt fearful. 1 2 3 4 B. 11. I felt my sleep was restless. 1 2 3 4 Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

4 DURING THE PAST WEEK, HOW OFTEN DID YOU FEEL THIS WAY? rarely or none of the time ( less than one day) some or a little of the time ( 1 2 days) occasionally or moderate amount of time ( 3 4 days) most or all of the time ( 5 7 days)

B. 12. I was happy. 1 2 3 4 B. 13. I talked less than usual. 1 2 3 4 B. 14. I felt lonely. 1 2 3 4 B. 15. I felt people were unfriendly. 1 2 3 4 B. 16. I enjoyed life. 1 2 3 4 B. 17. I had crying spells. 1 2 3 4 B. 18. I felt sad. 1 2 3 4 B. 19. I felt that people disliked me. 1 2 3 4 B. 20. I could not A get going." 1 2 3 4 Female Mental Health/ Financial Security 6 Month ( Instrument # 25) 5 SECTION C.

Listed below are some things that might have occurred to you during the past month ( the last 4 weeks or so).

Please circle yes for those items you have experienced during the past month, and circle no if you have not experienced the item.

If you circle yes, then circle one of the next numbers to show whether you think this had a negative or bad impact, or a positive or good impact.

For example, circle   3 if it was an extremely negative or bad impact. Circle 0 if you thought there was no impact. Circle + 3 to indicate an extremely positive impact. Negative/ Bad or Positive/ Good impact on your life?

 Negative/ Bad   Positive/ Good

DURING THE PAST MONTH,

HAVE YOU: Did this happen during the past month? Extremely negative Moderately negative somewhat negative no impact somewhat positive moderately positive extremely positive C. 1. gotten married [ wedding during past month] no yes

 3  2  1 0 + 1 + 2 + 3 C. 2. been in jail or a similar institution no yes

 3  2  1 0 + 1 + 2 + 3 C. 3. had your spouse or partner die no yes

 3  2  1 0 + 1 + 2 + 3 C. 4. had a major change in your sleeping habits ( much more sleep or much less sleep) no yes

 3  2  1 0 + 1 + 2 + 3 C. 5. experienced the death of a close family member ( your child, father, mother, sister, brother,

grandparent or other) no yes

 3  2  1 0 + 1 + 2 + 3 C. 6. had a major change in your eating habits ( ate much more or less food) no yes

 3  2  1 0 + 1 + 2 + 3 C. 7. experienced a foreclosure on a mortgage or a loan no yes

 3  2  1 0 + 1 + 2 + 3 C. 8. experienced the death of a close friend no yes

 3  2  1 0 + 1 + 2 + 3 C. 9. had an outstanding personal achievement no yes

 3  2  1 0 + 1 + 2 + 3 Female Mental Health/ Financial Security 6 Month ( Instrument # 25) 6 Negative/ Bad or Positive/ Good impact on your life?

 Negative/ Bad   Positive/ Good

DURING THE PAST MONTH,

HAVE YOU: Did this happen during the past month? extremely negative Moderately negative somewhat negative no impact somewhat positive moderately positive extremely positive C. 10. had a minor law violation ( such as a traffic ticket or disturbing the peace) no yes

 3  2  1 0 + 1 + 2 + 3 C. 11. changed your work situation ( such as different work responsibility, a major change in working conditions or working hours) no yes

 3  2  1 0 + 1 + 2 + 3 C. 12. started a new job no yes

 3  2  1 0 + 1 + 2 + 3 C. 13. had one of your close family members have a serious illness or injury ( your spouse/ partner,

child, father, mother, sister, brother,

grandparent or other) no yes

 3  2  1 0 + 1 + 2 + 3 C. 14. had sexual difficulties no yes

 3  2  1 0 + 1 + 2 + 3 C. 15. had trouble with your boss ( such as you were in danger of losing your job, being suspended, or demoted) no yes

 3  2  1 0 + 1 + 2 + 3 C. 16. had trouble with your in laws no yes

 3  2  1 0 + 1 + 2 + 3 C. 17. had a major change in your financial status ( a lot better off or a lot worse off) no yes

 3  2  1 0 + 1 + 2 + 3 C. 18. had a major change in your closeness to family members ( increased or decreased closeness) no yes

 3  2  1 0 + 1 + 2 + 3 C. 19. gained a new family member ( through adoption or a family member moving in) no yes

 3  2  1 0 + 1 + 2 + 3 C. 20. moved to a new place no yes

 3  2  1 0 + 1 + 2 + 3 Female Mental Health/ Financial Security 6 Month ( Instrument # 25) 7 Negative/ Bad or Positive/ Good impact on your life?

 Negative/ Bad   Positive/ Good

DURING THE PAST MONTH,

HAVE YOU: Did this happen during the past month? extremely negative Moderately negative somewhat negative no impact somewhat positive moderately positive extremely positive C. 21. had a separation from your spouse or partner because you were not getting along no yes

 3  2  1 0 + 1 + 2 + 3 C. 22. had a major change in church activities ( increased or decreased attendance) no yes

 3  2  1 0 + 1 + 2 + 3 C. 23. got back together with your spouse or partner no yes

 3  2  1 0 + 1 + 2 + 3 C. 24. had a major change in the number of arguments you have with your spouse or partner ( a lot more or a lot fewer arguments) no yes

 3  2  1 0 + 1 + 2 + 3 C. 25. had a change in your spouse's or partner's work ( lost job or started a new job) no yes

 3  2  1 0 + 1 + 2 + 3 C. 26. had a major change in the usual type and/ or amount of recreation no yes

 3  2  1 0 + 1 + 2 + 3 C. 27. borrowed more than $ 15,000 ( such as buying a home or business) no yes

 3  2  1 0 + 1 + 2 + 3 C. 28. borrowed less than $ 15,000 ( such as buying a car or getting a school loan) no yes

 3  2  1 0 + 1 + 2 + 3 C. 29. been fired from a job no yes

 3  2  1 0 + 1 + 2 + 3 C. 30. had a major personal illness or injury no yes

 3  2  1 0 + 1 + 2 + 3 C. 31. had a major change in social activities, such as parties, movies, visiting, either increased or decreased no yes

 3  2  1 0 + 1 + 2 + 3 Female Mental Health/ Financial Security 6 Month ( Instrument # 25) 8 Negative/ Bad or Positive/ Good impact on your life?

 Negative/ Bad   Positive/ Good

DURING THE PAST MONTH,

HAVE YOU: Did this happen during the past month? extremely negative Moderately negative somewhat negative no impact somewhat positive moderately positive extremely positive C. 32. had a major change in living conditions of your family ( built a new home, remodeled, had your home or neighborhood decline) no yes

 3  2  1 0 + 1 + 2 + 3 C. 33. got a divorce no yes

 3  2  1 0 + 1 + 2 + 3 C. 34. had a close friend with a serious injury or illness no yes

 3  2  1 0 + 1 + 2 + 3 C. 35. had a son or daughter leave home, such as because of a marriage or school no yes

 3  2  1 0 + 1 + 2 + 3 C. 36. ended your formal schooling no yes

 3  2  1 0 + 1 + 2 + 3 C. 37. had a separation from your spouse because of work, travel, or family needs no yes

 3  2  1 0 + 1 + 2 + 3 C. 38. got engaged to be married no yes

 3  2  1 0 + 1 + 2 + 3 C. 39. left home for the first time no yes

 3  2  1 0 + 1 + 2 + 3 Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

9 Section D Cohen Perceived Stress Scale Now think about how often you felt or thought these certain ways during the past month.

Although some of the questions are similar, there are differences between them. Be sure to treat each one as a separate question. Don't spend too much time thinking about your answer  the best approach is to answer each question quickly.

In the past month, how often have you

Never Almost never Sometimes Fairly Often Very Often D. 1. been upset because of something that happened unexpectedly? 0 1 2 3 4 D. 2. felt that you were unable to control the important things in your life? 0 1 2 3 4 D. 3. felt nervous and Astressed?@ 0 1 2 3 4 D. 4. felt confident about your ability to handle your personal problems? 0 1 2 3 4 D. 5. felt that things were going your way? 0 1 2 3 4 D. 6. found that you could not cope with all the things that you had to do? 0 1 2 3 4 D. 7. been able to control irritations in your life? 0 1 2 3 4 D. 8. felt that you were on top of things? 0 1 2 3 4 D. 9. been angered because of things that happened that were outside your control? 0 1 2 3 4 D. 10. felt difficulties were piling up so high that you could not overcome them? 0 1 2 3 4 Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

10 Section E Child rearing support 1. Is there a man who is acting as this child's father? This might be the baby's biological father or it might be another man who is currently your partner, but not the biological father?

1 YES 2 NO 2. After the baby was born, would you say your relationship with him got better, worse, or stayed the same?

1 BETTER 2 WORSE 3 STAYED THE SAME 3. How pleased and excited is he about the baby?

1 VERY PLEASED 2 SOMEWHAT PLEASED 3 NOT PLEASED 4. How often have you talked with him about concerns you have about your baby, such as how you're feeling about the time it takes to care for the baby, the baby's health, or how your lives have changed since the baby was born?

1 ALMOST EVERY DAY 2 A FEW TIMES A WEEK 3 A FEW TIMES A MONTH 4 ONCE OR TWICE SINCE THE BABY WAS BORN 5 NEVER 5. Since the baby was born, has he done extra things for you so you do not have as much to do, such as taking care of the house, shopping, or taking care of your other children?

1 A LOT OF EXTRA THINGS 2 A FEW EXTRA THINGS 3 NO CHANGE IN THE AMOUNT OF HELP 6. How often does he get up at night to care for the baby? Would you say... 1 AT LEAST ONCE A NIGHT 2 A FEW NIGHTS A WEEK 3 A FEW NIGHTS A MONTH 4 NEVER 5 HE DOESN'T LIVE WITH YOU 6 BABY ALMOST ALWAYS SLEEPS THROUGH THE NIGHT OR SLEEPS IN THE SAME BED 7. How much emotional support would you say you get from him?

1 A LOT 2 SOME Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

11 3 NOT MUCH 4 NONE AT ALL 8. Now please think about the first person, ( other than the man we were just talking about), to whom you turn when you need to talk or get some help. What is this person's relationship to you?

1 MOTHER OR MOTHER IN LAW 2 GRANDMOTHER 3 SISTER 4 ANOTHER RELATIVE 5 A FRIEND 6 ANOTHER PERSON 7 NONE OF THE ABOVE

SKIP TO QUESTION 11 9. What was this person's reaction when you had the baby?

1 VERY EXCITED 2 SOMEWHAT EXCITED 3 NOT EXCITED 10. How often have you talked to this person about any concerns you have about your baby, such as how you are feeling or how your life has changed after the baby was born?

1 ALMOST EVERY DAY 2 A FEW TIMES A WEEK 3 A FEW TIMES A MONTH 4 ONCE OR TWICE SINCE BABY WAS BORN 5 NEVER 11. Since your baby was born, would you say the baby's father has provided the most emotional support to you or has it been someone else?

1 BABY'S FATHER 2 ANOTHER PERSON 3 ABOUT THE SAME AMOUNT OF SUPPORT FROM EACH Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

12 SECTION F.

The next few questions are about whether you feel you have enough money for yourself and the people in your house.

F. 1. At this time, do you feel you are able to afford a home suitable for yourself and your family?

1 YES 2 NO F. 2. Do you feel you are able to afford the furniture or household equipment that you need at this time?

1 YES 2 NO F. 3. Do you feel you are you able to afford the kind of car you need?

1 YES 2 NO F. 4. At this time, do you have enough money for the kind of food you think you and your family should have?

1 YES 2 NO F. 5. Do you have enough money for the kind of medical care you and your family should have?

1 YES 2 NO F. 6. At this time, do you have enough money for the kind of clothing you and your family should have?

1 YES 2 NO F. 7. Do you have enough money for the leisure activities you and your family want?

1 YES 2 NO Female Mental Health/ Financial Security 6 Month ( Instrument # 25)

13 F. 8. How difficult is it for you and your family to pay your bills?

1. Very difficult 2. Somewhat difficult 3. Not very difficult 4. Not difficult at all F. 9. At the end of the month, how much money would you say you end up with?

1. Not enough money 2. Just enough money 3. Some money left over 4. A lot of money left over F. 10 Since your child was born, have you received benefits from the WIC program, that is, the Women, Infants and Children program?

1 YES 2 NO F. 11 Since your child was born, have you or any members of your household been authorized to receive Food Stamps ( which includes a food stamp card or voucher, or cash grants from the state for food)?

1 YES 2 NO [ END]