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

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.

The Food and Drug Administration (FDA) has determined ROCEPHIN (ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for any of these products if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. The Agency believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling.

The Food and Drug Administration (FDA) is reopening until June 30, 2011, the comment period for the notice of public meeting, published in the Federal Register of August 9, 2010 (75 FR 47820), entitled ``Generic Drug User Fee; Public Meeting; Request for Comments.'' In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period for the expected duration of the active negotiation phase to ensure that all interested stakeholders have the opportunity to share their views on the matter.

The Department of Health and Human Services published a notice in the Federal Register of March 4, 2011, announcing a call for comment on the draft report of the Adult Immunization Working Group to the National Vaccine Advisory Committee. It was announced that the draft report and recommendations could be found on the Web at https:// www.hhs.gov/nvpo/nvac/subgroups/adultimmunization. The Web address where the draft report and recommendations can be found is https:// www.hhs.gov/nvpo/nvac/subgroups/adultimmunization.html.

This interim final rule with comment period 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 resident cap reductions.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title IIIA New Paradigm for Importers.'' The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the import safety provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is seeking information on importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing a public hearing to provide stakeholders the opportunity to discuss FDA's use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed and lessons learned through equivalence determinations. The public hearing will include a separate discussion of FDA's efforts to gather information from regulators in other countries regarding the regulatory policies, practices, and programs they currently use to ensure the safety of foods and animal feed imported into their countries.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 026'' (Recognition List Number: 026), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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 National Cancer Institute (NCI), 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: Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study. Type of Information Collection Request: New. Need and Use of Information Collection: The AARP-based study is one component of a multi-center biomarker validation study project involving two other large cohorts in the United States. The iDATA study involves large cohorts and provides the necessary sample size to evaluate the measurement error structure of the diet and physical activity assessment instruments and the heterogeneity of the measurement error structure across multiple and diverse study populations. The iDATA study will include 1,500 participants from the NIH-AARP Diet and Health Study and current AARP membership. The data collection instruments adhere to The Public Health Service Act, which provides authority to the Risk Factor Monitoring and Methods Branch in the Division of Cancer Control and Population Sciences and the Division of Cancer Epidemiology and Genetics. Both divisions work to reduce cancer in the U.S. population by establishing and supporting programs for the detection, diagnosis, prevention and treatment of cancer; and by collecting, identifying, analyzing and disseminating information on cancer research, diagnosis, prevention and treatment. Dietary and physical activity data will be gathered using the instruments as detailed below. In addition, biospecimen and clinic data will be also gathered. Frequency of Response: Monthly. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-74). The annual reporting burden is provided for each study component as shown in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

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 National Institute of Drug Abuse (NIDA), 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.

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 medical device labeling regulations.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft guidance provides recommendations to applicants considering whether to request a waiver or reduction in user fees. This guidance is a revision of the draft guidance entitled ``Draft Interim Guidance Document for Waivers of and Reductions in User Fees,'' issued July 16, 1993.

The National Institute for Occupational Safety and Health (NIOSH), CDC, HHS, in collaboration with the National Truck Equipment Association, Ambulance Manufacturers Division (NTEA-AMD) has developed a series of proposed ambulance component test standards. One such standard, AMD STANDARD 026Seat, Seat Mount and Occupant Restraint Dynamic TestProposed (draft), seeks to improve occupant and seat retention during crash conditions. As a part of the standard development process, NIOSH will be conducting a series of tests to evaluate existing, redesigned, and/or new seating to validate the test methods proposed. It is anticipated testing will be conducted in up to three phases over approximately 15 months. NIOSH will contract with an independent test facility and provide funding for all testing, instrumentation, data collection, and data analysis. Prospective industry partners will provide the following test assets: Seating, seat retention devices, and occupant restraints. This project has three key goals: (1) To validate test and data collection methodologies proposed in AMD 026 (draft) to support standard development; (2) to support and facilitate the transition of the industry from the current seating design parameters to those proposed in SAE J2917 Surface Vehicle Recommended Practice, Occupant Restraint and Equipment Mounting IntegrityFrontal Impact System-Level Ambulance Patient Compartment, published May 2010, and SAE J2956 Surface Vehicle Recommended Practice, Occupant Restraint and Equipment Mounting IntegritySide Impact System-Level Ambulance Patient Compartment (draft); and, (3) to develop the design and production ``cost-of-change'' to meet the proposed design parameters.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee''). 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 the outcomes associated with the use of unilateral and bilateral cochlear implant technology for hearing loss. 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 National Cancer Institute, Division of Cancer Treatment and Diagnosis, is announcing the final revision of the NCI Cancer Therapy Evaluation Program's Intellectual Property Option to Collaborator.

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 IT Tool Evaluation.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The NIEHS is updating its strategic plan. To anticipate, meet, and set priorities for environmental health research, training, resources, and technologies, NIEHS requests input from scientists, staff, stakeholders, members of the public, and all interested parties. The goal of this strategic planning process is to define an overarching Vision Statement, Strategic Goals, and Implementation Strategies for the NIEHS. To begin the process, the institute is asking for the online submission of Visionary Ideas. In addition, the NIEHS seeks the nomination of interested individuals to participate in a Stakeholder Community Workshop to identify, discuss, and develop the draft strategic goals that will form the basis of the Strategic Plan. The current NIEHS Strategic Plan can be viewed at: https:// www.niehs.nih.gov/about/od/strategicplan/strategicplan2006/in dex.cfm.

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 issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Mark E. Van Wormer, MD, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Van Wormer was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Van Wormer was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. In a January 1, 2011, letter to FDA, Dr. Van Wormer notified FDA that he did not plan to seek a hearing and therefore has waived his right to a hearing concerning this action.

On January 5, 2011 HHS/CDC published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (76 FR 678) proposing to amend its regulations (42 CFR 71.53) for the importation of live nonhuman primates (NHPs). Written comments were to be received on or before March 7, 2011. We have received a request asking for a 45 day extension of the comment period. In consideration of that request, HHS/ CDC is extending the comment period by 45 days to April 25, 2011.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the 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 December 17, 2010 (75 FR 79009) and allowed 60 days for public comment. No public comments were received. 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. Proposed Collection: Title: Questionnaire Cognitive Interview and Pretesting. Type of Information Collection Request: Extension. Need and Use of Information Collection: The purpose of the data collection is to conduct cognitive interviews, focus groups, Pilot household interviews, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common evaluation method is the cognitive interview, in which a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews. When possible, cognitive interviews are conducted in the survey's intended mode of administration. Cognitive interviewing provides useful information on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. There are no costs to respondents other than their time. Frequency of Response: Once. Affected Public: Individuals and households, Private Sector (business or other for-profits, not-for-profit institutions) and possibly, State, Local or Tribal Governments. The table below represents the burden over a three-year data collection period, which is a typical request for a generic submission. The estimated total burden hours requested is 3,600 for the three-year clearance period. There are no annualized costs to respondents. The annualized costs to the Federal Government are estimated at $244,000 and include cost of NCI staff to plan, conduct, and analyze outcomes of questionnaire development, contracting for pretesting activities and research, travel costs, and additional materials needed to conduct and recruit participants for the research. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined the regulatory review period for AMPYRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Anastasios Pappas, MD, for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Pappas was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Pappas was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Pappas failed to respond. Dr. Pappas' failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Drug Evaluation and Research. A goal of the Center for Drug Evaluation and Research is to raise consumers' awareness of the importance of good medication adherence, a vital first step toward improved adherence behavior and better public health outcomes.

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, OHS leadership, and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)]. Dates & Locations: The initial 2011 OHS Tribal Consultation Sessions will be held as follows: Friday, March 25, 2011Rapid City, South DakotaBest Western Ramkota. Friday, April 1, 2011Boston, MassachusettsJFK Federal Building.

The Food and Drug Administration (FDA) is issuing a proposed rule to reclassify benzocaine from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status. Although, in the Federal Register of February 26, 1982, an advanced notice of proposed rulemaking (ANPR) included the recommendation of an Advisory Panel, consisting of health care providers from outside FDA, recommended that benzocaine should be generally recognized as safe and effective (GRASE) for weight control, this document includes our first evaluation of benzocaine for this use. Based on our evaluation of the available data and information, we have tentatively concluded that the data are not sufficient to support the safety and effectiveness of benzocaine for this use. This proposed rule, if finalized, would require an approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical investigations of medical devices indicated for the treatment of urinary incontinence.

The Food and Drug Administration (FDA) is clarifying that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests comments from the public on implementing the provisions of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111- 347). A copy of the Act is posted on the Internet at https:// www.cdc.gov/niosh/docket in the NIOSH Docket number 226. The Federal government is developing an implementation plan, and comments from the public will assist in this process by gaining perspectives from interested parties on ways to meet the Act's requirements. The public is invited to submit written comments to the NIOSH Docket number 226. A public meeting on March 3, 2011, was previously announced in the Federal Register (76 FR 7862) on February 11, 2011 to accept oral comments from the public. Public Comment Period: All comments must be received by April 29, 2011.

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 National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Section 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC ``to develop recommendations for establishing a comprehensive, sustainable, national adult immunization program that will lead to vaccine-preventable disease reduction by improving adult immunization coverage levels.'' The Adult Immunization Working Group (AIWG) of NVAC has developed a draft report and recommendations for the consideration of the NVAC. Individuals and organizations are encouraged to submit their comments on the draft report and recommendations. It is anticipated that the draft report and recommendations, as revised in accordance with public comment and stakeholder input, will be presented to the NVAC for deliberation and decision for adoption in mid- or late 2011.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Albert Poet, MD from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Poet was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Poet was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Poet failed to respond. Dr. Poet's failure to respond constitutes a waiver of his right to a hearing concerning this action.

This notice announces that the charter of the Advisory Panel on Medicare Education (APME), as renamed the Advisory Panel on Outreach and Education (APOE), has been renewed and the scope of the charter has been expanded. It also requests nominations for individuals to serve on the APOE.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled ``Infant Formula Label Statements Experimental Study.''

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Testing Communications on Medical Devices and Radiation-Emitting Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough, cold, or allergy, Docket Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N- 0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), have been withdrawn. Therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar (IRS) product that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice.

The Food and Drug Administration (FDA) is amending its regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature- indicating devices, in addition to mercury-in-glass thermometers, during processing. This final rule also establishes recordkeeping requirements relating to temperature-indicating devices and reference devices maintained by the processor and allows for the use of advanced technology for measuring and recording temperatures during processing. Finally, this final rule includes metric equivalents of avoirdupois (U.S.) measurements where appropriate. This final rule will allow low- acid canned food processors to transition from mercury-in-glass thermometers to alternative temperature-indicating devices. Use of temperature-indicating devices that do not contain mercury will eliminate concerns about potential contamination of the food or the processing environment from broken mercury-in-glass thermometers. Elsewhere in this issue of the Federal Register, FDA is publishing a 30-day notice announcing that it has submitted the information collection provisions of this final rule to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). The notice also invites the public to submit comments on the information provisions to OMB. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions of the final rule.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation. The Advisory Council on Blood Stem Cell Transplantation was established pursuant to Public Law 109-129 as amended by Public Law 111-264; 42 U.S.C. 274k; Section 379 of the Public Health Service Act. In accordance with Public Law 92-463, the Council was chartered on December 19, 2006.

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 PRA).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the 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 December 23, 2010 (75 FR 80830) and allowed 60-days for public comment. No public comments were received. 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. Proposed Collection: Title: Generic Submission of Technology Transfer Center (TTC) External Customer Satisfaction Surveys (NCI). Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of these web-based surveys are to: obtain information on the satisfaction of TTC's external customers with TTC customer services; collect information of preferred and expected communications channels of TTC's external customers; and assess the strategic direction of companies engaging in collaborations and alliances with the NIH. The needs of external technology transfer customers and stakeholders have never been assessed systematically. Input from these groups is essential for defining workflow process improvements for services provided by the NCI TTC to the research community. The results will be used to strengthen the operations of the NCI TTC, including the Competitive Service Center. This questionnaire adheres to The Public Health Service Act, Section 413 (42 USC 285a-2) which authorizes the Director of the National Cancer Institute in carrying out the National Cancer Program to ``encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research;'' Frequency of Response: Once. Affected Public: Private Sector. Type of Respondents: Managers, Executives and Directors from Foundations, Not-for-Profit and For- profit organizations that conduct research and development in biomedical applications. The three year reporting burden is estimated in Table 1, as is a standard request for generic submissions. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined that NILSTAT (nystatin powder (oral, 100%)) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nystatin powder (oral, 100%) if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is confirming the effective date of March 30, 2011, for the final rule that appeared in the Federal Register of November 15, 2010 (75 FR 69586). The direct final rule amends the regulations regarding new animal drugs for minor use and minor species (MUMS) to update language and clarify the intent of the regulations consistent with the preambles to the proposed and final rules. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

The Food and Drug Administration (FDA) is amending the food additive regulations to permit the use of hydrogen peroxide as an antimicrobial agent in the manufacture of modified whey by ultrafiltration methods. This action is in response to a petition filed by Fonterra (USA), Inc.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-fourth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ ohrp/sachrp/mtgings/.