Department of Health and Human Services September 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing this notice to request that industry trade associations, whose members include drug companies currently engaged in development or manufacture of biosimilar biological products in the U.S., or drug companies intending to engage in these activities during the period of FY 2018-2022, notify FDA of their intent to participate in industry stakeholder meetings in support of timely reauthorization of the Biosimilar User Fee Act of 2012 (BsUFA). The statutory authority for BsUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees to fund the biosimilar biological product review process. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA engage in negotiations with regulated industry to develop recommendations to present to Congress with respect to the reauthorization of BsUFA. The purpose of this request for notification is to ensure that qualifying industry organizations notify FDA of their intention to participate in the planned negotiation process.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (PRA). This notice invites comment on the three- year extension of information collection clearance for the ``Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation'' project (OMB Control No. 0923-0046; expiration date 05/31/2016). The purpose of the study is to examine the potential association between environmental contaminants (i.e., uranium and other heavy metal exposures) and reproductive birth outcomes by recruiting Navajo mothers to assess and follow theirs and their children's uranium exposures at birth and at key developmental milestones.

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide and guidance for industry #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' This guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule that published in the Federal Register on June 3, 2015. The purpose of this document is to describe the Veterinary Feed Directive requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a Veterinary Feed Directive drug (VFD feed).

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Public Health Service, Department of Health and Human Services, is contemplating the grant of an exclusive license to Research Think Tank Molecular Diagnostics, Inc. (RTTMDx) having a principal place of business in Georgia, U.S.A., to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 577,696, filed June 07, 2004, entitled ``Real-Time PCR Point Mutation Assays for Detecting the 103N and 184V Mutations in the Reverse Transcriptase of HIV-1'' (HHS Ref. No. E-198-2013/0-U.S.-01); PCT Application No. PCT/U.S.2005/019907, filed June 07, 2005, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-PCT-02); U.S. Patent Application No. 14/059,085, filed October 21, 2013, entitled ``Real- Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-11); U.S. Patent No. 8,043,809, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-07); U.S. Patent No. 8,318,428, filed January 24, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance for Antiviral Drugs'' (HHS Ref. No. E-198- 2013/0-U.S.-08); U.S. Patent No. 8,592,146, filed September 04, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-09); Australian Patent No. 20055252685, issued March 31, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs,'' (HHS Ref. No. E-198-2013/0-AU-03); Indian Patent No. 19/DELNP/2007, issued December 19, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-IN-06); Canadian Patent Application No. 2,891,079, filed May 19, 2015, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-12); Canadian Patent Application No. 259747, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-04); U.S. Provisional Patent Application No. 61/443,926, filed February 17, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-01); PCT Patent Application No. PCT/ U.S.2012/025638, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-PCT-02); U.S. Application No. 13/ 985,499, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-06); Canadian Patent Application No. 2827324, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-CA-03); European Patent Application No. 12747199.3, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-EP-04); Indian Patent Application No. 7110/ DELNP/2013, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-IN-05); U.S. Provisional Patent Application No. 61/829,473, filed May 31, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs (HHS Ref. No. E-511-2013/0-U.S.-01); PCT Application No. PCT/U.S.2014/ 040514, filed June 02, 2014, entitled, ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-511-2013/0-PCT-02). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Patent License may be worldwide, and the field of use may be limited to ``Development, manufacture, and sale of an FDA-approved or foreign equivalent-approved Class III real-time PCR diagnostic assay for HIV-1 genotyping utilizing whole HIV-1 pol viral sequencing, limited to use in humans.''

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

The Food and Drug Administration (FDA or Agency) has determined that ORTHO EVRA (norelgestromin/ethinyl estradiol) Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin and 0.035 mg/24hr ethinyl estradiol was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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 U.S. Centers for Disease Control and Prevention (CDC) is providing $1,300,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the New York City Department of Health (NYC HD)to combat an outbreak of Legionella. As of August 18, 2015 NYC HD has identified 127 cases and 12 deaths associated with this public health emergency. These funds will be used by NYC HD to (1) create sustainable environmental and laboratory capacity at NYC HD to respond to Legionella outbreak, (2) enhance laboratory capacity of detection, isolation, and molecular characterization of clinical and environmental strains at the New York City public health laboratory, (3) include sequence-based typing and eventually whole genome sequencing, and (4) allow NYC HD to characterize the geographic distribution of Legionella strains throughout New York City, support the new public health engineering program to monitor the compliance of building owners with the new cooling tower regulations, and work with CDC to evaluate the impact of these regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound- Specific Acceptable Intakes.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance, an addendum to the ICH M7 guidance of May 28, 2015, provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagens and carcinogens, and that were selected because they are commonly used in pharmaceutical manufacturing or are useful in illustrating the principles for deriving compound-specific intakes as described in ICH M7. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 and outlines the payment procedures for such fees.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) invites nominations of individuals qualified to serve as members of the Community Preventive Services Task Force (CPSTF).

HRSA announces its intent to award a program expansion supplement in the amount of $75,000 for the Bright Futures Pediatric Implementation (BFPI) cooperative agreement. The purpose of the BFPI cooperative agreement, as stated in the funding opportunity announcement, is to improve the quality of health promotion and preventive services for all infants, children, adolescents, and their families, including children with special health care needs, through the effective national implementation of Bright Futures Guidelines for Health Supervision of Infants, Children and Adolescents, Third Edition (Bright Futures). The purpose of this notice is to award supplemental funds to collect baseline information to measure the improvement of coordination activities between home visiting and primary care providers by the American Academy of Pediatrics, the cooperative agreement awardee who serves as the BFPI, during the budget period of February 1, 2015, to January 31, 2016. The BFPI is authorized by the Social Security Act, Title V, Sections 501(a)(2) (42 U.S.C. 701(a)(2)), as amended. The BFPI is a national resource to promote integration of the Bright Futures through strengthening, aligning, and fostering partnerships among families, health professionals, public health, and the broader community to promote children's health.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2016. The calendar year 2016 AIC threshold amounts are $150 for ALJ hearings and $1,500 for judicial review.

This final notice announces our decision to approve the American Association of Diabetes Educators (AADE) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Angio360 Diagnostics, LLC, a company having a place of business in Wauwatosa, Wisconsin, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 858,068, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed November 9, 2006 (HHS Ref. No.: E- 285-2006/0-US-01); US Provisional Patent Application No. 60/879,457, entitled ``Organ And Tumor Associated Endothelial Markers,'' filed January 8, 2007 (HHS Ref. No. E-285-2006/1-US-01); PCT Application No. PCT/US2007/072395, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 8, 2007 (HHS Ref. No. E-285-2006/2-PCT-01); U.S. Patent Application No. 12/514,297, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed May 8, 2009 (HHS Ref No. E-285-2006/ 2-US-02); Australian Patent No. 2007-317753, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref No. E-285-2006/2-AU-03); Canadian Patent Application No. 2,669,260, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref. No. E-285-2006/2-CA-04); U.S. Patent No.: 8,440,411, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed March 21, 2011 (HHS Ref. No. E-285-2006/2-US-05); U.S. Patent Application No. 13/052,878, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed April 16, 2013 (HHS Ref. No.: E-285-2006/2-US-06); and Australian Application Patent No.: 2014-200453, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed January 28, 2014 (HHS Ref No. E-285-2006/2-AU-07). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development of diagnostic tests and kits to determine or monitor pathological angiogenesis related to cancer in animals or humans.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Angio360 Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.

The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.

The HIV/AIDS Bureau (HAB) is requesting a class deviation from the competition requirements in order to provide a one-year extension with funds to nineteen Part C HIV Early Intervention Services Program Existing Geographic Service Area (EISEGA) grantees. HAB is currently evaluating the EISEGA program and intends to recompete the entire program in fiscal year (FY) 2017. Nineteen of the 347 Part C grantees were scheduled to recompete in FY 2016. One-year extensions with funds enables HAB to align all cohorts of EISEGA grantees without disrupting the provision of critical HIV primary medical care services to the current Ryan White HIV/AIDS Program (RWHAP) clients served by these nineteen RWHAP Part C recipients. Pending the availability of funds, the amount of each FY 2016 award will be based on a proportion of the current Part C EISEGA award to each of the nineteen recipients, respectively.

The Health Resources and Services Administration (HRSA) will be issuing a noncompetitive award for the Center for Integrative Medicine in Primary Care program. Approximately $330,000 will be made available in the form of a cooperative agreement to the University of Arizona, Center for Integrative Medicine in Primary Care program, Tucson, Arizona (HP 2771) during the current budget/project period of September 1, 2014, through August 31, 2017. This cooperative agreement was fully funded for a 3-year project period on September 1, 2014. The purpose of the Center for Integrative Medicine in Primary Care program is to incorporate competency based Integrative Medicine (IM) curricula and practices into existing primary care residencies and other health professions training programs. This center is expected to contribute to the evidence-base for IM, and to identify promising practices related to the integration of IM into primary care and interprofessional practice. The Center formally partners with existing primary care residency programs (pediatrics, internal medicine, family medicine, preventive medicine) and other health professions training programs (nursing, physician assistant, public health, and behavioral health among others) to: (a) Pilot and implement the incorporation of IM into the curricula and training; (b) Provide faculty development; (c) Engage in interprofessional education and practice; (d) Develop practice-based IM rotations for residents and students; (e) Reach out to underserved populations through existing training sites to spread IM practice; (f) Identify promising IM practices through the work of the program; and (g) Evaluate students' and faculty members' knowledge gained and practice changes made through IM trainings and curriculum development.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Administration for Community Living proposes to submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships. CDC will use the information to continue the ongoing longitudinal follow-up for CDC's teen dating violence (TDV) prevention initiative, Dating Matters[supreg]: Strategies to Promote Healthy Teen Relationships.

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

The Food and Drug Administration (FDA) is classifying the oral electronic vision aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral electronic vision aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Healthcare Associated Venous Thromboembolism (HA-VTE) Prevention Challenge on November 2, 2015. The challenge will be open until January 10, 2016. Venous thromboembolism (VTE), blood clots occurring as deep vein thrombosis (DVT), pulmonary embolism (PE), or both, is an important and growing public health issue. Prevention of healthcare associated VTE (HA-VTE) is a national hospital safety priority. Many HA-VTEs can be prevented, but VTE prevention strategies and are still not being applied regularly or effectively across the United States. To support and promote HA-VTE prevention, HHS/CDC is announcing the 2015 HA-VTE Prevention Challenge. The challenge will bring prestige to organizations that invest in VTE prevention, improve understanding of successful implementation strategies at the health system level, and motivate health systems to strengthen their VTE prevention efforts. The top-judged organizations found to have implemented innovative and effective VTE prevention strategies will be recognized as HA-VTE Prevention Champions. HHS/CDC will document these successful strategies and highlight the systems, processes, and staffing that contributed to exceptional VTE prevention outcomes achieved by Champions. Champions will receive a cash prize (if eligible) and other forms of recognition.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of a draft strategic plan entitled NIOSH Oil and Gas Sector ProgramStrategic Plan for Research and Prevention, 2016-2025 for public comment. The document and instructions for submitting comments can be found at www.regulations.gov.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6).

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: ``Online Submission Form for Supplemental Evidence and Data for Systematic reviews for the Evidence-based Practice Center Program.'' 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 or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product- specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed collection Active Monitoring of Travelers Coming from Ebola-affected Countries and Their Contacts Currently Residing in State, Territorial, and Local Jurisdictions.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Patient Engagement Advisory Committee (the Committee), Office of the Center Director, Center for Devices and Radiological Health. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is requesting industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) for the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Committee. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS, to implement the Proposed Action, referred to as the Proposed Action in the Final EIS. This action is to install a Thermal Energy Storage System and an Industrial Water Storage System to provide sufficient storage capacity to meet two days of chilled water demand and two days of industrial water demand should an outside disturbance interrupt the water supply.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 9, 2015, page 19090 and allowed 60-days for public comment. One comment was received. However, it was not applicable to this data collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0279, scheduled to expire on September 30, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Food and Drug Administration (FDA or Agency) is changing the Agency's long standing practice of not publically posting on http:/ /www.regulations.gov comments submitted by individuals in their individual capacity. These are generally comments from people who self- identify as an ``individual consumer'' under the field titled ``Category (Required)'' on the ``Your Information'' page on https:// www.regulations.gov. Changing FDA's practice to routinely post these comments, as we do other comments, will increase the transparency and public utility of FDA's public dockets. It will better enable our public dockets to function as intended: To share information and encourage an open exchange of ideas.

This final notice announces our decision to approve the request from Doctors Hospital at Renaissance for an exception to the prohibition against expansion of facility capacity.

HRSA announces the award of a program expansion supplement in the amount of $100,000 for the Alliance for Innovation on Maternal and Child Health (AIM) cooperative agreement. The purpose of the AIM cooperative agreement, as stated in the funding opportunity announcement (FOA), is to expand access to care for the maternal and child health (MCH) populations through the following program focus areas: (1) Ensuring continuity of coverage and care for pregnant women and children; (2) improving systems of care for children with special health care needs; and (3) promoting the use of Bright Futures Guidelines for all children. The program expansion supplement will provide funds to the Association of State and Territorial State Health Officials (ASTHO), the cooperative agreement awardee, during the budget period of September 30, 2015, through September 29, 2016, to provide targeted technical assistance to two States at risk for rapid transmission of HIV and Hepatitis C virus (HCV) through injection drug use, to build capacity and expand access to care, document and share best practices with other State Health Officials also seeking to prevent HIV and HCV infection through injection drug use.

The Food and Drug Administration (FDA or we) is correcting a document that appeared in the Federal Register of July 24, 2015, entitled ``User Fee Program for Accreditation of Third-Party Auditors/ Certification Bodies To Conduct Food Safety Audits and To Issue Certifications.'' That document proposed amending the document, ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,'' and proposed establishing a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA). The document was published with an incorrect RIN. This document corrects that error.

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 Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a small business and pay certain medical device user fees at reduced rates.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the RA). The purpose of the RA is to provide a science-based risk analysis of those activity/animal food combinations that would be considered low risk when conducted in an animal food facility co-located on a farm. We conducted this RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.

The Food and Drug Administration (FDA or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home FoodsPart II (Menu Labeling Requirements in Accordance with 21 CFR 101.11); Draft Guidance for Industry.'' The draft guidance, when finalized, will help certain restaurants and similar retail food establishments comply with the menu labeling requirements, including the requirements to provide calorie and other nutrition information for standard menu items, including food on display and self-service food.

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 (NIEHS), 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. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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).

HRSA announces the award of a one-time extension in the amount of $54,244 each to four State Planning Grants for Improving Services for Children and Youth with Autism Spectrum Disorder (ASD) and Other Developmental Disabilities (DD) grants. The purpose of the program is to support states in the planning and development of activities that are designed to improve state systems of care for children and youth with ASD and related DDs and increase access to comprehensive coordinated health care. Grantees develop comprehensive, measurable state plans in collaboration with a diverse group of stakeholders that outline an approach to improve access to comprehensive, coordinated health care and related services for children and youth with ASD and other DDs. The purpose of this notice is to award a one-time, 12-month extension to ensure the completion of activities and an orderly phase out of HRSA support.

This document reopens the comment period for the July 16, 2015 proposed rule entitled ``Reform of Requirements for Long-Term Care Facilities''. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a newly proposed information collection request entitled Improving Fetal Alcohol Spectrum Disorders Prevention Practice through Practice and Implementation Centers and National Partnerships.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on (June 30, 2015 P.37280) 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 Cancer Institute (NCI), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0166, scheduled to expire on October 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.