Document ID: EPA-HQ-OPPT-2013-0171-0008
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program
Posted Date: 2015-08-03T04:00Z

[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 oira_submission@omb.eop.gov. 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: robbins.jane@epa.gov.

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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