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

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 ``Experimental Study on Comparing Data Obtained From Landline Telephone and Cell Phone Surveys.''

This interim final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to establish rules governing the distribution of rebates by issuers in group markets for non-Federal governmental plans.

This final rule implements Section 10332 of the Affordable Care Act regarding the release and use of standardized extracts of Medicare claims data for qualified entities to measure the performance of providers of services (referred to as providers) and suppliers. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers and suppliers. This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries.

The Food and Drug Administration (FDA) is extending the comment period until January 19, 2012, for an advance notice of proposed rulemaking (ANPRM) that was published in the Federal Register of September 9, 2011 (76 FR 55835). In that document, FDA requested 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, email, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients. The Agency is extending the comment period in response to a request to give interested parties additional time to comment.

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Department of Agriculture's (USDA) Agricultural and Marketing Service, Farm Service Agency, and Food Nutrition Service. The purpose of the MOU is to provide a framework for the parties to communicate and cooperate in the timely and full exchange of information to optimize controls essential to minimizing potential for the distribution or use of USDA foods which may be unsafe. For the purpose of this MOU, the term ``USDA foods'' will mean commodities procured by USDA for use in domestic nutrition assistance programs.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to inform our Pressure Ulcer Treatment Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

The National Institutes of Health (NIH) has analyzed public comments received regarding adoption and implementation of the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide) and has determined to adopt the 8th Edition of the Guide. (The comments, received by NIH from February 24 to May 24, 2011, may be viewed at https://grants.nih.gov/grants/olaw/2011guidecomments/web listing.htm.) In NIH's judgment, the 8th Edition of the Guide empowers continued advancement in the humane care and use of vertebrate animals in research, research training, and biological testing. Effective January 1, 2012, institutions that receive Public Health Service (PHS) support for animal activities must base their animal care and use programs on the 8th Edition of the Guide and must complete at least one semiannual program review and facilities inspection using the 8th Edition of the Guide as the basis for evaluation by December 31, 2012. It is not required that all necessary changes be completed by December 31, 2012, but rather that an evaluation must be conducted and a plan and schedule for implementation of the standards in the 8th Edition of the Guide must be developed by December 31, 2012. Institutions must verify to the Office of Laboratory Animal Welfare (OLAW), the organizational component of NIH that provides guidance and interpretation of the PHS Policy on Humane Care and Use of Laboratory Animals, that they have met the required schedule. This will be done through the Annual Report to OLAW covering the 2012 reporting period due January 31, 2013. In addition, institutions must document the implementation of the 8th Edition of the Guide in their next Animal Welfare Assurance renewal. OLAW has developed Position Statements located at https:// grants.nih.gov/grants/olaw/2011positionstatement.htm. The Position Statements clarify the ways in which NIH expects Assured institutions to implement the 8th Edition of the Guide by addressing the following concerns: cost of implementing the 8th Edition of the Guide; animal housing specifications; use of nonpharmaceutical-grade compounds; food and fluid restrictions; multiple surgical procedures; and application of the 8th Edition of the Guide to agricultural animals used in biomedical research. In addition, there is a summary of OLAW's position on performance standards and practice standards. The public is invited to submit comments on their understanding of the Position Statements for a period of 60 days from December 1, 2011, to January 29, 2012. In response, OLAW may further clarify the Position Statements.

The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2013 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2012 through September 30, 2013. This notice announces the calculated FMAP and eFMAP rates that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid) and Children's Health Insurance Program (CHIP) expenditures, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. Table 1 gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice also announces the disaster-recovery FMAP adjustments for qualifying states for FY 2013 that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid) and title IV-E Foster Care, Adoption Assistance and Guardianship Assistance programs. Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits given in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 States. Section 1905(b) of the Act specifies the formula for calculating FMAPs as follows:

This notice announces a new application deadline for participation in the Advance Payment Model for certain accountable care organizations participating in the Medicare Shared Savings Program scheduled to begin in 2012.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) for CY 2012 to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we set forth the relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other ratesetting information for the CY 2012 ASC payment system. We are revising the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, adding new requirements for ASC Quality Reporting System, and making additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are allowing eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. Finally, we are making changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces a series of Webinars to provide information for individuals and groups interested in learning more about the National Healthy Worksite Program. The National Healthy Worksite Program is an HHS/CDC initiative to establish and evaluate comprehensive workplace health programs to improve the health of workers and their families. Registration for the Webinars is free.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 facility in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

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 Department of Bioethics, 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.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, as amended on February 25, 2009, and on August 23, 2010, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). Following issuance of FDA's August 23, 2010, amended Authorization letter, on April 8, 2011, BARDA submitted a request on behalf of ASPR to further amend the Authorization to reflect certain programmatic changes, including by replacing references to the CRI with the National Postal Model (NPM). In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization in its entirety on October 14, 2011. The Authorization, as amended and reissued, includes explanations for its reissuance and is reprinted in this document.

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: ``Medical Office Survey on Patient Safety Culture Comparative Database.'' 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 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 (PRA). The proposed collection of information concerns a guidance document that outlines the criteria and the process through which firms may request a reduction of fees based on severe economic hardship of the FDA Food Safety Modernization Act (FSMA) reinspection and recall user fees that are mandated by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

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 long range (75 year) projection methods and assumptions in projecting Medicare health expenditures and projecting National Health Expenditures and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. 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 project 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 Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for addition of a warning statement against the use of eprinomectin topical solution in preruminating calves intended for veal.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adverse Experience Reporting for Licensed Biological Products; and General Records'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This final rule exempts the system of records (09-15-0054, the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, HHS/HRSA/BHPr) for the National Practitioner Data Bank (NPDB) from certain provisions of the Privacy Act (5 U.S.C. 552a). The exemption is necessary due to the recent expansion of the NPDB under section 1921 of the Social Security Act to include the investigative materials compiled for law enforcement purposes reported to the Healthcare Integrity and Protection Data Bank (HIPDB). The system of records for the HIPDB is exempt from certain provisions of the Privacy Act (see 45 CFR 5b.11(b)(2)(ii)(F)). In order to maintain the exemption for the HIPDB investigative materials, which will now also be available through the NPDB, it is necessary to extend the same exemption to the NPDB.

Under the provisions of Section 3507(a) (1)(D) of the Paperwork Reduction Act of 1995, 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 July 27, 2011, (76 FR 44937) and allowed 60 days for public comment. Twelve 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: The Genetic Testing Registry; Type of Information Collection Request: New collection; Need and Use of Information Collection: Laboratory tests for more than 2,000 genetic conditions are available; however, there is no centralized public resource that provides information about the availability and scientific basis of these tests. Recognizing the importance of making this information easily accessible to health care providers, patients, consumers, and others, NIH is developing a voluntary registry of genetic tests. The Genetic Testing Registry (GTR) will provide a centralized, online location for test developers, manufacturers, and researchers to submit detailed information about genetic tests. The overarching goal of the GTR is to advance the public health and research in the genetic basis of health and disease. As such, the Registry will have several key functions, including (1) Encouraging providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; (2) providing an information resource for the public, including health care providers, patients, and researchers, to locate laboratories that offer particular tests; and (3) facilitating genetic and genomic data-sharing for research and new scientific discoveries. Frequency of Response: The information will be submitted voluntarily on a non-repeating, continual basis. Submitters will be requested to update their test information at least once every 12 months. Respondents: Submitters to the GTR are expected to include clinical laboratories, researchers, and entities that report and interpret tests performed elsewhere. The GTR is not limited to U.S. respondents; it will also include submissions from outside the United States. Information will be collected and managed using an online submission system. Estimate of Burden: Although participation in the GTR is voluntary, in order to participate, respondents must provide information for a certain subset of fields, identified as the ``minimal fields.'' GTR includes 31 minimal fields and 85 optional fields. Sixteen of the 31 minimal fields refer to contact data and other information about the laboratory, which the respondent completes only once. These data will autopopulate new test records, leaving 15 minimal fields that require completion. The GTR will also support bulk submission as an XML file or uploading subsets of information from spreadsheets, which will significantly reduce the burden for laboratories that want to provide information on multiple genetic tests. The annualized cost to respondents is estimated at $1,103.

The National Health and Nutrition Examination Survey (NHANES) will not be receiving DNA proposals in 2012. NHANES is changing its plan for making DNA available for genetic research and its proposal guidelines. NHANES anticipates that the DNA Bank will be open for proposals approximately January 2013.

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.

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: ``Assessing the Feasibility of Disseminating EHC Products through Educational Activities.'' 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 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 NIEHS and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) request public comments that can be considered by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and agencies' program offices in updating The NICEATM- ICCVAM Five-Year Plan (2008-2012) (ICCVAM, 2008). The current plan addresses: (1) Identification of areas of high priority for new and revised non-animal and alternative assays to reduce, refine (enhance animal well-being and lessen or avoid pain and distress), and replace the use of animals in testing and (2) research, development, translation, and validation of new and revised non-animal and other alternatives assays for integration of relevant and reliable methods into Federal agencies' testing programs.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Medication Guides Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the guidance addresses when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be provided with a drug or biological product that is dispensed to a health care professional for administration to a patient instead of being dispensed directly to the patient for self-administration or to the patient's caregiver for administration to the patient. Second, the guidance addresses when a Medication Guide will be required as part of a REMS. The guidance is intended to answer questions that have arisen concerning these topics.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Followup Study for Infant Feeding Practices Study II'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, January 25, 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 the management of carotid atherosclerosis. 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 its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods. FDA is issuing a final regulation in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by requiring, among other things, the listing on food labels of the common or usual names of all color additives required to be certified by FDA. An additional purpose of this final rule is to make these regulations consistent with the regulations regarding the declaration of certified color additives on the labels of human food. The final rule also suggests appropriate terminology for the declaration of certification-exempt color additives on the labels of animal food.

AHRQ has accepted a notification of voluntary relinquishment from Emergency Medicine Patient Safety Foundation of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

AHRQ has accepted a notification of voluntary relinquishment from Child Health Patient Safety Organization, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

The NTP announces that the public listening session on the proposed review process for the Report on Carcinogens on November 29, 2011, has been extended from 1-5 p.m. (EST) to 1-7 p.m. (EST). Registration to present oral remarks is increased from the first 15 to the first 23 registrants who wish to speak, with one time slot per organization. However, the total number of connections available for all registrants (including speakers plus observers) remains at 50. Presenters will speak in the order that they are registered. The agenda, including the list of speakers, will be posted on the NTP Web site (https://ntp.niehs.nih.gov/go/rocprocess) prior to the November 29, 2011, listening session. Information regarding the listening session was published on October 31, 2011, in the Federal Register (76 FR 67200) and is available on the NTP Web site (https://ntp.niehs.nih.gov/go/rocprocess). The guidelines and deadlines published in the Federal Register notice still apply except as noted above. Any updates or additional information will be posted on the NTP Web site.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption for Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined that TRAVATAN (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for travoprost ophthalmic solution, 0.004%, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Recall Regulations'' 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 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.

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: ``Assessing the Feasibility of Disseminating Effective Health Center Products through Mobile Phone Applications.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Brookhaven National Laboratory, Upton, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Brookhaven National Laboratory. Location: Upton, New York. Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor agencies, and its contractors and subcontractors. Period of Employment: January 1, 1980 through December 31, 1993.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (FDA Form 3671)'' 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 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 information collection requirements for reclassification petitions for medical devices.