## 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 Publication No. 03–4504. Research Triangle 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. OECD. 2009. Test No 455: The Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals. In: OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects. Paris: OECD Publishing. Available: http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicalssection-4-health-effects

_20745788.

Rogers JM, Denison MS. 2000. Recombinant cell bioassays for endocrine disruptors: Development of a stably transfected human ovarian cell line for the detection of estrogenic and anti-estrogenic 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