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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (214) entitled ``Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data'' (VICH GL35). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommended standards to construct a single electronic message to transmit data elements for submission of adverse event reports (AERs) to all member regions.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health Literacy Item Set Supplemental to CAHPS Health Plan SurveyPretest of Proposed Questions and Methodology.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 7th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (208) entitled ``Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide a general description of the criteria that have been found by the European Union, Japan, the United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (206) entitled ``Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals'' (VICH GL47). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary drugs produced by laboratory animals used for toxicological testing for the purpose of comparison to the residues of veterinary drugs in edible tissues of food-producing animals.

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This 2.5-day public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ``how to'' aspects of improving outsourced product quality through topics such as Strategic Procurement, End-to-End lifecycle product management, Managing Global Complex Supply Chains, and other topics. The experience level of our audience has fostered engaged dialog that has lead to innovative initiatives. Dates and Times: The public conference will be held on October 3, 2011, from 8:30 a.m. to 5 p.m., October 4, 2011, from 8:30 a.m. to 5 p.m., and October 5, 2011, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this document: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, e-mail: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, dinners, and dinner speakers for the 2.5 days of the conference. Prior online registration or registration by mail must be done by October 3, 2011. There will also be onsite registration. The cost of registration is as follows:

This notice is a request for information regarding section 1331 of the Affordable Care Act, which provides States with the option to establish a Basic Health Program. This option permits States to enter into contracts to offer one or more ``standard health plans'' providing at least the essential health benefits described in section 1302(b) of the Affordable Care Act to eligible individuals in lieu of offering such individuals coverage through the Affordable Insurance Exchange (Exchange).

The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its Tobacco Products Scientific Advisory Committee, notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $2,100,000 (total costs) for up to one year to Link2Health Solutions, Inc. the current grantee for the National Suicide Prevention Lifeline. This is not a formal request for applications. Assistance will be provided only to Link2Health Solutions, Inc based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-11-015.

This notice extends the deadline for hospitals to apply to the Centers for Medicare & Medicaid Services (CMS) to receive St. Vincent's Medical Center's full time equivalent (FTE) resident cap slots. The application deadline, which was September 28, 2011, has been extended to December 1, 2011.

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 requirements for filing objections and requests for a hearing on a regulation or order.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This draft guidance document is intended to assist persons submitting warning plans to FDA under the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act; and under the Federal Cigarette Labeling and Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control Act, when that requirement takes effect.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products. FDA is taking this action as part of its implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is requesting comments, data, research, or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, e-mail, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients.

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 revisions to Form FDA 3500 and Form FDA 3500A, and proposed consumer version of Form FDA 3500 (known as the MedWatch reporting form) used in the FDA Medical Products Reporting Program.

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the report of the International Research Panel titled, Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, available for review at https:// www.bioethics.gov.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, 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: The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT tools. Type of Information Collection Request: NEW. Need and Use of Information Collection: The Epidemiology and Biostatistics section in RMD will be collecting information through a contractor (Boston UniversityHealth and Disability Research Institute (BU-HDR)) and subcontractor for validation of the Computer Adaptive Tests which are being developed to assist in the SSA disability determination process. The utilization of CAT technology could potentially allow the SSA to collect more relevant and precise data about human functioning in a faster, more efficient fashion. To validate the CAT assessments that have been developed, the contractor will administer both the BU-HDR CAT and established legacy instruments in a small sample of adults who report their current employment status as ``permanently disabled''. Individuals will complete the CAT tools for the functional domains of Physical Demands and Interpersonal Interactions along with established legacy instruments. For the domain of physical function, individuals will complete the BU-HDR CAT; the PROMIS Item Bank v 1.0Physical Functioning (copyright) PROMIS Health Organization and PROMIS Cooperative Group; and The Short Form (36) Health SurveyTM (SF-36). For the domain of interpersonal interactions, individuals will complete the BU-HDR CAT, the SF-36 and the BASIS- 24(copyright) (Behavior and Symptom Identification Scale). Data collected will be used to validate the BU-HDR CAT tools. Without this information, completion of the BU-HDR CAT tools will not be possible. Frequency of Response: Once. Affected Public: Individuals who have opted in to participate in web surveys through a survey research firm. Type of Respondents: Adults who indicate ``permanently disabled'' as a working status. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. The annual reporting burden is as follows:

This document contains the final Administration for Children and Families (ACF) Tribal Consultation Policy outlining the policy to engage in meaningful consultation with federally recognized tribes and the procedures and processes to be followed by tribes and the ACF bureaus and offices when the need for consultation is requested or required.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent.'' The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and will supersede OHRP's November 15, 1996 guidance document entitled ```Exculpatory Language' in Informed Consent'' and question number 52 in FDA's January 1998 guidance entitled, ``Institutional Review Boards Frequently Asked Questions Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.'' The draft guidance is intended primarily for institutional review boards (IRBs), investigators, sponsors, and funding agencies that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS or regulated by FDA.

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 contained in existing FDA regulations regarding the general administrative procedures for a person to petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to file a petition for an administrative reconsideration or an administrative stay of action; and to request an advisory opinion from the Commissioner.

The NTP is postponing the release of the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy during Pregnancy and the peer review panel meeting. Release of the draft monograph was scheduled for September 9, 2011, and the meeting for October 19-20, 2011; both were announced on August 17, 2011 (76 FR 51034). Information about rescheduling the release of the draft monograph and the peer review will be announced in the Federal Register and posted on the NTP Web site at https://ntp.niehs.nih.gov/go/36639.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, August 12, 2011 (76 FR 50231). The document announced a public workshop entitled ``Mobile Medical Applications Draft Guidance.'' The document was published with an outdated address in the section entitled ``Will there be transcripts of the meeting?'' This document corrects that error.

A notice was published in the Federal Register on Tuesday, July 5, 2011, Vol. 76, No. 128, to announce that a meeting of the Advisory Committee on Minority Health (ACMH) was scheduled to be held on Monday, August 29, 2011 from 9 a.m. to 5 p.m., and Tuesday, August 30, 2011, from 9 a.m. to 1 p.m. This meeting has been cancelled in its entirety. The meeting was cancelled because of the weather projections that the Washington, DC metropolitan area would be affected by a significant hurricane. The meeting was cancelled to ensure the safety of the Committee members, Federal staff, and all other interested parties. Information about this meeting being rescheduled will be posted on the Committee's Web site, which can be accessed at https:// minorityhealth.hhs.gov.

The Health Resources and Services Administration published a notice in the Federal Register, (76 FR 50442, Doc. 2011-20690), on August 15, 2011, announcing the meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas on September 20, 21, and 22, 2011. The dates of the meeting and contact information were incorrect.

This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under REACH CORE, Racial and Ethnic Approaches to Community Health Communities Organized to Respond and Evaluate. These applications have been previously received and competed in response to CDC Funding Opportunity CDC-RFA- DP10-1014. It is the intent of CDC to provide continuation funding to one (1) previously received and reviewed application with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, August 12, 2011 (76 FR 50230). The document announced a public workshop entitled ``Recommendations Proposed in Institute of Medicine Report: `Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years.' '' The document was published with an outdated address in the section entitled ``Will there be transcripts of the meeting?'' This document corrects that error.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``PET Drug ApplicationsContent and Format for NDAs and ANDAs.'' This document is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.

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)).