8260 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 

References 

EPA. 2009. Endocrine Disruptor Screening 

Program Test Guidelines. OPPTS 890.1300: 

Estrogen Receptor Transcriptional Activation 

(Human Cell Line (HeLa-9903)). Washington, 

DC: U.S. Environmental Protection Agency. 

Available: http://www.regulations.gov/ 

#!documentDetail;D=EPA-HQ-OPPT-2009- 

0576-0006. 

ICCVAM. 2011. ICCVAM Test Method 

Evaluation Report: The LUMI–CELL® ER 

(BG1Luc ER TA) Test Method: An In Vitro 

Assay for Identifying Human Estrogen 

Receptor Agonist and Antagonist Activity of 

Chemicals. Research Triangle Park, NC: 

National Institute of Environmental Health 

Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

ERTA-TMER.htm. 

ICCVAM. 2006. Addendum to ICCVAM 

Evaluation of In Vitro Test Methods for 

Detecting Potential Endocrine Disruptors. 

Research Triangle Park, NC: National 

Institute of Environmental Health Sciences. 

Available: http://iccvam.niehs.nih.gov/docs/ 

endo_docs/EDAddendFinal.pdf. 

ICCVAM. 2003a. ICCVAM Evaluation of In 

Vitro Test Methods For Detecting Potential 

Endocrine Disruptors: Estrogen Receptor and 

Androgen Receptor Binding and 

Transcriptional Activation Assays. NIH 

Publication No. 03–4503. Research Triangle 

Park, NC: National Institute of Environmental 

Health Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

end_TMER.htm. 

ICCVAM. 2002a. Background Review 

Document. Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Estrogen Receptor Transcriptional Activation 

Assays. NIH Publication No. 03–4505. 

Research Triangle Park, NC: National 

Institute of Environmental Health Sciences. 

Available: http://iccvam.niehs.nih.gov/ 

methods/endocrine/end_bckgnd.htm#ERTA. 

ICCVAM. 2002b. Background Review 

Document. Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Androgen Receptor Binding Assays. NIH 

Publication No. 03–4506. Research Triangle 

Park, NC: National Institute of Environmental 

Health Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

end_bckgnd.htm#ARBnd. 

ICCVAM. 2002c. Background Review 

Document: Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Estrogen Receptor Binding Assays. NIH 

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Park, NC: National Institute of Environmental 

Health Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

end_bckgnd.htm#ERBnd. 

ICCVAM. 2002d. Background Review 

Document. Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Androgen Receptor Transcriptional 

Activation Assays. NIH Publication No. 03– 

4507. Research Triangle Park, NC: National 

Institute of Environmental Health Sciences. 

Available: http://iccvam.niehs.nih.gov/ 

methods/endocrine/end_bckgnd.htm#ARTA. 

ICCVAM. 2002e. Expert Panel Evaluation 

of the Validation Status of In Vitro Test 

Methods for Detecting Endocrine Disruptors: 

Estrogen Receptor and Androgen Receptor 

Binding and Transcriptional Activation 

Assays. Expert Panel Final Report. Research 

Triangle Park, NC: National Institute of 

Environmental Health Sciences. Available: 

http://iccvam.niehs.nih.gov/methods/ 

endocrine/end_EPrpt.htm. 

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http://www.oecd-ilibrary.org/environment/ 

oecd-guidelines-for-the-testing-of-chemicalssection-4-health-effects_20745788. 

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Recombinant cell bioassays for endocrine 

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transfected human ovarian cell line for the 

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chemicals. In Vitro Mol Toxicol 13(1):67–82. 

Dated: February 7, 2012. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2012–3437 Filed 2–13–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10421] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

Correction 

In notice document 2012–2821 

appearing on pages 6123–6124 in the 

issue of February 7, 2012, make the 

following correction: 

On page 6124, in the first column, in 

the last line, ‘‘April 9, 2012’’ should 

read ‘‘April 3, 2012’’. 

[FR Doc. C1–2012–2821 Filed 2–13–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0110] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Reporting: Manufacturer, Importer, 

User Facility, and Distributor Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 extension of 

an existing collection of information, 

and to allow 60 days for public 

comment in response to the notice. This 

notice solicits comments on medical 

device reporting (MDR); manufacturer, 

importer, user facility, and distributor 

reporting. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 16, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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 

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