[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45974-45975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18849]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2013-0171; FRL 9925-37-OEI]
Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Tier 2 Data Collection for Certain Chemicals
Under the Endocrine Disruptor Screening Program (EDSP)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA has submitted the following information collection request
(ICR) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (PRA): ``Tier 2
Data Collection for Certain Chemicals Under the Endocrine Disruptor
Screening Program (EDSP)'' and identified by EPA ICR No. 2479.01 and
OMB Control No. 2070-New. The ICR, which is available in the docket
along with other related materials, provides a detailed explanation of
the collection activities and the burden estimate that is only briefly
summarized in this document. EPA has addressed the comments received in
response to the previously provided public review opportunity issued in
the Federal Register on June 24, 2013, 78 FR 37803. With this
submission, EPA is providing an additional 30 days for public review.
DATES: Comments must be received on or before September 2, 2015.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0171, to both EPA and OMB as follows:
To EPA online using http://www.regulations.gov (our
preferred method) or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460.
To OMB via email to [email protected]. Address
comments to OMB Desk Officer for EPA.
EPA's policy is that all comments received will be included in the
docket without change, including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.
FOR FURTHER INFORMATION CONTACT: Jane Robbins, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-6625; email address: [email protected].
SUPPLEMENTARY INFORMATION:
Docket: Supporting documents, including the ICR that explains in
detail the information collection activities and the related burden and
cost estimates that are summarized in this document, are available in
the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The telephone number for the Docket Center is (202)
566-1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
ICR status: This ICR is for a new information collection activity.
Under PRA, 44 U.S.C. 3501 et seq., 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.
The OMB control numbers are displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers for certain EPA regulations is consolidated in 40 CFR
part 9.
Abstract: This ICR covers the information collection activities
associated with Tier 2 data collection activities for certain chemicals
under EPA's EDSP. The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)), which
requires EPA to develop a chemical screening program using appropriate
validated test systems and other scientifically relevant information to
determine whether certain substances may have hormonal effects. The
EDSP consists of a two-tiered approach to screen chemicals for
potential endocrine disrupting effects. The purpose of Tier 1 screening
is to identify substances that have potential bioactivity in the
estrogen, androgen, or thyroid hormone systems using a battery of
assays. Substances that have potential bioactivity with estrogen,
androgen or thyroid hormone systems may proceed to Tier 2, which is
designed to identify any adverse endocrine-related effects caused by
the substance, and establish a quantitative relationship between the
dose and that endocrine effect. Additional information about the EDSP
is available through the Agency's Web site at http://www.epa.gov/endo.
[[Page 45975]]
This ICR addresses the information collection activities for those
chemicals that were screened under Tier 1 of the EDSP and are now
proceeding to testing under Tier 2 of the EDSP. The ICR covers the
information collection activities associated with Tier 2 of the EDSP.
As such, this ICR addresses the paperwork activities associated with
generating the data requested, and submitting the data to EPA pursuant
to the order.
Respondents/Affected Entities: Those individuals and companies that
receive an EDSP Tier 2 order issued by the Agency. Under FFDCA section
408(p)(5)(A), EPA ``shall issue'' EDSP test orders ``to a registrant of
a substance for which testing is required . . . or to a person who
manufactures or imports a substance for which testing is required.''
Respondent's obligation to respond: FFDCA section 408(p)(5)
obligates test order recipients to respond.
Estimated total number of potential respondents: 100.
Frequency of response: On occasion.
Estimated total burden: 83,116 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Estimated total costs: $5,861,023 (per year). This primarily
represents estimated labor cost, with related administrative costs of
$104. Given the nature of the activities, there are no costs estimated
for capital investment or maintenance and operational costs.
Changes in the estimates: This is a request for a new approval from
OMB.
Authority: 44 U.S.C. 3501 et seq.
Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-18849 Filed 7-31-15; 8:45 am]
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