Department of Health and Human Services August 2011 – Federal Register Recent Federal Regulation Documents

In FY 2011, HHS/ASPR/BARDA plans to supplement the FY2010 ``Single-Source Cooperative Agreement with the World Health Organization (WHO) to Continue Development of Sustainable Influenza Vaccine Production Capacity in Under Resourced Nations''. BARDA currently funds the development of vaccine manufacturing capacity in ten developing and emerging-economy countries worldwide via a cooperative agreement with the World Health Organization (WHO). The amount of Single Source Award is $6,021,535. The project period is September 1, 2011, through August 31, 2012.

The Office of Refugee Resettlement, ACF, HHS published a document in the Federal Register of August 16, 2011 (76 FR 50744), concerning the issuance of an urgent single-source grant to Survivors of Torture, International (SOTI), San Diego, CA. The document contained incorrect information in citing the statutory authority for making this award. Correction: In the Federal Register of August 16, 2011 (76 FR 50744), ORR omitted the primary authority for issuing this award. The notice should have included the following: Awards announced in this notice are authorized by the Torture Victims Relief Act (TVRA) of 1998,'' Public Law 105-320 (22 U.S.C. 2152 note), reauthorized by Public Law 109-165 in January 2006. Section 5 (a) of the TVRA of 1998 provides for ``Assistance for Treatment of Torture Victims. The Secretary of Health and Human Services may provide grants to programs in the United States to cover the cost of the following services: (1) Services for the rehabilitation of victims of torture, including treatment of the physical and psychological effects of torture. (2) Social and legal services for victims of torture. (3) Research and training for health care providers outside of treatment centers, or programs for the purpose of enabling such providers to provide the services described in paragraph (1).'' And by Section 412 (c)(1)(A) of the Immigration and Nationality Act (INA) (8 U.S.C. 1522(c)(1)(A), as amended, and the Refugee Assistance Extension Act of 1986, Public Law 99-605, Nov 6, 1986, 100 Stat. 3449.

The Food and Drug Administration (FDA) has determined that TALWIN COMPOUND (aspirin; pentazocine hydrochloride (HCl)) tablets, 325 milligrams (mg); equivalent to (EQ) 12.5 mg base, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for aspirin; pentazocine HCl tablets, 325 mg; EQ 12.5 mg base, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) extended-release tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended- release tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Anesthetic and Life Support Drugs Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.

This notice announces the availability of one toxicological profile, prepared by ATSDR for the Department of Defense, on Royal Demolition eXplosive (RDX), chemical name hexahydro-1,3,5-trinitro- 1,3,5-triazine, also known as cyclonite.

The Food and Drug Administration (FDA) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2012.

Under the provisions of Section 3507(a)(l)(D) of the Paperwork Reduction Act of 1995 for the opportunity for public comment on the proposed data collection projects, the Center for Scientific Review (CSR), National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 22, 2011 (Vol. 76, No. 141, p. 44020) and allowed 60-days for public comment. There was one public comment received during this time. The purpose of this notice is to allow 30 days for public comment. The National Institutes of Health may not conduct or sponsor and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Extension of Generic Clearance for Voluntary Partner and Customer Satisfaction Surveys. Type of Information Collection Request: Extension. Need and Use of Information Collection: The information collected in these surveys will be used by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys will almost certainly lead to quality improvement activities to enhance and/or streamline CSR's operations. The major mechanism by which CSR will request input is through surveys. The major initiatives ongoing at the present time include: Shortening the review and application process, shortening the grant application, recruiting the best reviewers by developing additional review modes, improving study section alignment to ensure the best reviews, and others. Surveys will be collected via Internet. Information gathered from these surveys will be presented to, and used directly by, CSR management to enhance the operations, processes, organization of, and services provided by the Center. Frequency of Response: The participants will respond once, unless there is a compelling reason for a subsequent survey. Affected public: Universities, not-forprofit institutions, business or other forprofit, small businesses and organizations, and individuals. Type of Respondents: Adult scientific professionals.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-146-2004/0, Purcell et al., ``Monoclonal Antibodies That Neutralize Anthrax Protective Antigen (PA) Toxin'', U.S. Patent Application Number 60/ 639,074, filed on December 22, 2004, PCT Application Number PCT/US2005/ 046/790, filed on December 21, 2005, and U.S. Patent Application Number 11/793,735, filed on December 8, 2009, (2) E-123-2007/0, Purcell et al., ``Monoclonal Antibodies that Neutralize B. anthracis Protective Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)'', U.S. Patent Application Number 60/903,022, filed on February 23, 2007, PCT Application Number PCT/US2008/054609, filed on February 21, 2008, and U.S. Patent Application Number 12/528,427, filed on August 24, 2009, and European Patent Application Number 08730415.0, filed on September 23, 2009, (3) E-125-2008/0, Purcell et al., ``Monoclonal Antibodies That React With the Capsule of Bacillus anthracis'', U.S. Patent Application Number 61/116,222, filed on November 19, 2008, PCT Application Number PCT/US2009/065198, filed on November 19, 2009, and U.S. Patent Application Number 13/130,044, filed on May 18, 2011, (4) E-343-2002/0, Schneerson et al., ``gammaPGA Conjugates for Eliciting Immune Responses Directed Against Bacillus anthracis and Other Bacilli'', U.S. Patent Application Number 60/476,598, filed on June 5, 2003, PCT Application Number PCT/US2004/17736, filed on June 4, 2004, U.S. Patent Application Number 10/559,825, filed December 2, 2005, now U.S. Patent Number 7,803,386, European Patent Application Number 04754360.8, filed June 4, 2004, Canadian Patent Application Number 2,528,067, filed June 4, 2004, and Australian Patent Application Number 2004252091, filed June 4, 2004, now Australian Patent Number 2004252091, and (5) E-040-2005/0, Schneerson et al., ``Methods for Preparing Immunogenic Conjugates'', U.S. Patent Application Number 11/ 005,851, filed on December 6, 2004, now U.S. Patent Number 7,625,736, PCT Application Number PCT/US2005/19678, filed June 3, 2005, European Patent Application Number 05758048.2, filed June 3, 2005, now European Patent Number 1765394 (rights were validated in Germany (Patent Number 602005015855), France (Patent Number 1765394), Great Britain (Patent Number 1765394), and Ireland (Patent Number 1765394)), Indian Patent Application Number 7703/DELNP/2006, filed June 3, 2005, Chinese Patent Application Number 200580018108.2, filed June 3, 2005, Australian Patent Application Number 2005249571, filed June 3, 2005, now Australian Patent Number 2005249571, Canadian Patent Application Number 2,568,364, filed June 3, 2005, and U.S. Patent Application Number 12/ 582,420, filed October 20, 2009, to Biologics Resources LLC, having a place of business in Boyds, Maryland, United States of America. The patent rights in these inventions have been assigned to the United States of America.

This notice announces the cancellation of the September 21, 2011 public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the July 22, 2011 Federal Register (76 FR 44011 through 44012). This notice also announces a public meeting on Wednesday, March 21, 2012. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding antivascular endothelial growth factor (anti-VEGF) treatment of diabetic macular edema (DME). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and readability of the regulations.

This notice announces a request for applications for organizations to participate in one or more of the initial four models under the Bundled Payments for Care Improvement initiative beginning in 2012.

The NIEHS is hosting a workshop entitled ``Advancing Research on Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects'' on September 26-27, 2011 at the Sheraton Chapel Hill, Chapel Hill, NC. This workshop is organized to include plenary sessions and small group breakout sessions on specific topics. It is open to the public to attend as observers. For more information and to register for this workshop, please visit https://tools.niehs.nih.gov/ conferences/dert/mixtures/. The deadline to register for this workshop is Monday, September 12, 2011. Registration is limited to 85 observers based on available space.

This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the short- term (10 year) projection methods and assumptions in projecting Medicare health spending for Parts C and D and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. They will also discuss the long term (75 year) projection methods and assumptions in projecting the National Health Expenditures and Medicare expenditures. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy.

The NIH Office of Technology Transfer extends invitations to attend the 2011 Technology Transfer Summit North America Conference.

The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register of August 4, 2011 (76 FR 47211). The Agency is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. The August 4, 2011, notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. The document was published with an error. This document corrects that error.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E2F Development Safety Update Report.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR can be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.

This notice provides public announcement of CDC's intent to fund Approved cooperative agreement applications previously received and competed in response to CDC Funding Opportunity, RFA-DP-09-001, ``Health Promotion and Disease Prevention Research Centers (U48).'' It is the intent of CDC to fund the applications with Patient Protection Affordable Care Act (ACA), Section 4002, appropriations. CFDA Number 93.542 is the ACA-specific CFDA number for this initiative.

The Food and Drug Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011. This meeting was announced in the Federal Register of July 19, 2011 (76 FR 42715). The postponement is due to the fact that the Agency recently received submissions from some of the investigational new drug (IND) application holders for anti-nerve growth factor (Anti-NGF) antibody drug products that contain large quantities of new information that will require additional time for Agency review prior to the advisory committee meeting.

This document contains proposed regulations regarding disclosure of the summary of benefits and coverage and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. This document implements the disclosure requirements to help plans and individuals better understand their health coverage, as well as other coverage options. The templates and instructions to be used in making these disclosures are being issued separately in today's Federal Register.

The Food and Drug Administration (FDA) has determined that PENTETATE ZINC TRISODIUM (zinc trisodium diethylenetriaminepentaacetate (Zn-DTPA)) solution for intravenous or inhalation administration, equivalent to (EQ) 1 gram (g) base/5 milliliters (mL) (EQ 200 milligrams (mg) base per mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)), if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is extending to October 12, 2011, the comment period for the notice that appeared in the Federal Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document entitled ``In Vitro Companion Diagnostic Devices.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source cooperative agreement with the University of Oklahoma Health Sciences Center. The goal of the FDA, Center for Drug Evaluation and Research, Office of Chief Scientist, is to develop technology to molecularly characterize peptide epitopes that are processed and presented on soluble HLA (human leucocyte antigen) expressed by human cells. Initial studies will examine and characterize influenza peptides isolated from several different soluble Class I HLAs produced from influenza infected human lung cell lines. There is a growing interest in developing universal vaccines for influenza by targeting conserved internal proteins to stimulate cross-protective CTLs (cytolytic T lymphocyte) to provide long-lasting immunity. It is therefore critically important to identify which viral epitopes are generated by antigen processing in influenza infected lung cells, the target cells of cell mediated immune response to respiratory viruses. FDA seeks a collaboration to develop this technology for this purpose which can then be applied to identifying and characterizing other HLA-presented epitopes in viral infections, cancer, and immune toxicities.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. We are updating the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implementing certain statutory changes made by the Affordable Care Act. In addition, we are finalizing an interim final rule with comment period that implements section 203 of the Medicare and Medicaid Extenders Act of 2010 relating to the treatment of teaching hospitals that are members of the same Medicare graduate medical education affiliated groups for the purpose of determining possible full-time equivalent (FTE) resident cap reductions.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: National Institutes of Health Construction Grants 42 CFR Part 52b (Final Rule). Type of Information Collection Request: Extension of OMB Control No. 0925-0424, expiration date 10/31/2011. Need and Use of the Information Collection: This request is for OMB review and approval of a renewal for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ``Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007.

The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER) by establishing four new Divisions under the Office of Generic Drugs. This reorganization includes the organization and their substructure components as listed in this document. This document is announcing the availability of the Staff Manual Guide that explains the details of this reorganization.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and developmentas well as during manufacturing and product life-cycle managementto ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The guidance is applicable to investigational new drug applications, new drug applications, abbreviated new drug applications, and supplemental new drug applications for TDDS, TMDS, and topical patch products.

This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges (``Exchanges''), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This proposed rule would implement sections of the Affordable Care Act related to Medicaid and CHIP eligibility, enrollment simplification, and coordination. In addition, this proposed rule also sets out the increased Federal Medical Assistance Percentage (FMAP) rates and the related conditions and requirements that will be available for State medical assistance expenditures relating to ``newly eligible'' individuals and certain medical assistance expenditures in ``expansion States'' beginning January 1, 2014, including a proposal of three alternative methodologies to use for purposes of applying the appropriate FMAP for expenditures in accordance with section 2001 of the Affordable Care Act.

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, including 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 the reporting requirements associated with extra label drug use in animals.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Procedures for Handling Section 522 Postmarket Surveillance Studies.'' This guidance document is intended to assist device manufacturers subject to a section 522 postmarket surveillance order imposed by FDA by providing an overview of section 522 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance study submissions. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Mobile Medical Applications Draft Guidance.'' The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment on the following topics: FDA's recently issued draft guidance document entitled ``Mobile Medical Applications,'' how FDA should approach accessories and particularly mobile medical applications that are accessories to other medical devices, and standalone software that provides clinical decision support. Date and Time: The public workshop will be held on September 12 and 13, 2011. Submit electronic and written comments by October 19, 2011. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Contact Person: Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993, 301-796-5528, Bakul.Patel@fda.hhs.gov. Registration and Requests for Oral Presentations: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this workshop must register online by 5 p.m. on September 9, 2011. For those without Internet access, please call the contact person to register. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should register as soon as possible. If you need special accommodations due to a disability, please contact Susan Monahan (e-mail: Susan.Monahan@fda.hhs.gov or phone: 301- 796-5661) no later than September 9, 2011. This workshop will also be provided via webcast. Persons interested in participating by webcast must register online by 5 p.m. on September 9, 2011. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but view using one connection per location. Webcast participants will be sent connection requirements. To register for the public workshopwhether attending in person or for the webcastplease visit https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, telephone, and FAX number. Registrants will receive confirmation once they have been accepted. You will be notified if you are on a waitlist. This workshop includes a public comment session. During online registration you may indicate if you wish to make an oral presentation during a public comment session at the public workshop, and which topic you wish to address in your presentation. FDA has included topics for comment in this document. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. All requests to make oral presentations, as well as presentation materials, must be sent to the contact person by September 9, 2011. Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments until October 19, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 24, 2011, Vol 76, 100, page 30177-30178, and allowed 60 days for public comment. One request for the draft instruments was received from the public. These were provided to the requestor. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), conducted an analysis to determine classification criteria using results from 3-animal tests that would provide eye hazard classification equivalent to testing conducted in accordance with current U.S. Federal Hazardous Substances Act (FHSA) regulations, which require the use of 6 to 18 animals. The results showed that using a classification criterion of at least 1 positive animal in a 3-animal test to identify eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals. ICCVAM developed draft recommendations based on the results of this analysis. NICEATM invites public comments on these draft ICCVAM recommendations.