Department of Health and Human Services November 2014 – Federal Register Recent Federal Regulation Documents

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.

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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.'' The draft guidance addresses the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which requires the Secretary of the Department of Health and Human Services to establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format. Specifically, the guidance establishes standards for how transaction information, transaction history, and transaction statements should be exchanged among trading partners through the extension and/or use of current systems and processes.

As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), is hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held and will be open to the public by Internet access only.

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 Office of the Director (OD), 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Sarah Carr, Acting Director, Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call non-toll-free number (301) 496-9838, or Email your request, including your address to: OCRBP-OSP@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Genetic Testing Registry, 0925-0651, Expiration Date 02/28/2015EXTENSION, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Clinical laboratory tests are available for more than 5,000 genetic conditions. The Genetic Testing Registry (GTR) provides a centralized, online location for test developers, manufacturers, and researchers to voluntarily submit detailed information about the availability and scientific basis of their genetic tests. The GTR is of value to clinicians by providing information about the accuracy, validity, and usefulness of genetic tests. The GTR also highlights evidence gaps where additional research is needed. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,536.

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. 209 and 37 CFR part 404 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.

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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (AMPS) Household Component'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 29th, 2014 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

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 on 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. Written comments and/or suggestions from the public and affected agencies are invited on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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. To Submit Comments and for Further Information: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Harold Perl, Ph.D., Chief, Prevention Research Branch, Division of Epidemiology, Services & Prevention Research, NIDA, 6001 Executive Blvd., Rockville, MD 20852 or call this non-toll-free number (301) 443-6504, or email your request, including your address to: hperl@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Proposed Collection: Assessing an Online Process to Study the Prevalence of Drugged Driving in the U.S: Development of the Drugged Driving Reporting System. Type of Information Collection Request: 0925- NEW. National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: The study seeks to provide an improved understanding of the prevalence of drugged driving among adult drivers in the U.S and will assess the effectiveness of the online survey implementation process. The primary objectives of the study are to: (a) To provide comprehensive data on drugged driving; (b) determine if the Drugged Driving Survey Instrument (DDS) is an effective and accurate measure of drugged driving among licensed U.S. Drivers aged 18 and older; and, (c) to assess the effectiveness of the survey implementation process, including various levels of incentives for participation to determine the appropriate/optimal incentive amount needed to obtain the desired number of total survey respondents within the timeframe within which survey data will be collected. The findings will provide valuable information concerning various aspects of substance use and driving behavior, including: (1) Demographic information about drivers who do and do not drive while impaired by medication and/or drugs (e.g. age, zip code, type of driver's license); (2) which drugs/medications are most likely to be used while driving; (3) drivers' beliefs and attitudes toward drugged driving. OMB approval is requested for 2 years. There are no direct costs to respondents other than their time. The total annualized estimated burden hours are 750.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS) announces the award of a single-source expansion supplement grant of $610,000 to Safe Place in Louisville, KY, to support costs associated with the expansion of the scope of approved activities under their award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).

The Food and Drug Administration (FDA) is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' The guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The guidance is intended to assist human drug compounders that elect to register as outsourcing facilities in registering, re-registering, or de-registering with FDA. The guidance provides information on how an outsourcing facility should submit facility registration information electronically in structured product labeling (SPL) format using FDA's electronic submission system. This guidance reflects the Agency's current thinking on the issues addressed by the guidance.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they have compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system. This revised draft guidance supersedes a draft guidance entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.''

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is publishing this notice requesting public comment on the proposed VAERS 2.0 form, which is intended to replace the current VAERS-1 form (https:// vaers.hhs.gov/resources/vaers_form.pdf). CDC and the U.S. Food and Drug Administration (FDA) co-administer the Vaccines Adverse Event Reporting System (VAERS), a post-licensure (i.e., after vaccines have been licensed by the FDA and are being used in the community) reporting system that accepts submitted reports of adverse events that occur after vaccination from healthcare providers, manufacturers, and the public. Healthcare providers and vaccine manufacturers are required to submit VAERS reports. The National Childhood Vaccine Injury Act of 1986, section 2125 of the Public Health Service Act (42 U.S.C. 300aa- 25) authorized VAERS. The current VAERS form has been used since 1990.

This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for organizations that provide outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The National Institutes of Health (NIH), Office of the Director (OD), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301-435-0941 or Email your request, including your address to curriem@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH), 0925-0648, Expiration Date 1/31/2015, EXTENSION, National Institutes of Health (NIH), Office of the Director (OD). Need and Use of Information Collection: We are not requesting changes for this submission. The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions. This information, however, is not statistical surveys that yield quantitative results, which can be generalized to the population of study. This feedback will provide information about the NIH's customer or stakeholder perceptions, experiences, and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between the NIH and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the NIH's services will be unavailable. The NIH will only submit a collection for approval under this generic clearance if it meets the following conditions: The collections are voluntary; The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government; The collections are non-controversial and do not raise issues of concern to other Federal agencies; Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; Personally identifiable information (PII) is collected only to the extent necessary and is not retained; Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency; Information gathered will not be used for the purpose of substantially informing influential policy decisions; and Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4,358.

This notice announces a 3-year Medicare Prior Authorization model for non-emergent hyperbaric oxygen therapy services in the states of Illinois, Michigan, and New Jersey where there have been high incidences of improper payments for these services.

This final notice announces our decision to approve DNV GL Healthcare (DNV GL) \1\ for continued recognition as a national accrediting organization (AO) for critical access hospitals (CAH) that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Report on the Standardization of Risk Evaluation and Mitigation Strategies'' that appeared in the Federal Register of September 23, 2014. The document misstated the name of an organization. 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 the recordkeeping requirements for substances prohibited for use in animal food or feed.

This Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM). This proposed rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place via webinar. This webinar will be open to the public. Registration is required for those who wish to provide public testimony.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $236,000 as a single-source program expansion supplement to the National Resource Center on Domestic Violence in Harrisburg, PA. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs.

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled ``Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.'' CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Amprion, Inc. located in Houston Texas, USA, to practice the inventions embodied in the following Patents and Patent Applications, each entitled ``Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein'': 1. US provisional Application 60/961,364 filed July 20, 2007 [HHS Ref. No. E-109-2007/0-US-01] 2. PCT/US2008/070656, filed July 21, 2008; [HHS Ref. No E-109-2007/ 1-PCT-01] 3. EPC application No 08796382.3 filed July 21, 2008 [HHS Ref. No E-109-2007/1-EP-03] 4. US Application No. 12/177,012, filed July 21, 2008 and issued as US patent 8,216,788 on July 10, 2012 [HHS Ref. No E-109-2007/1-US-02]; 5. US Application No. 13/489,321, filed June 5, 2012 [E-109-2007/1- US-04]; 6. US Application No. 14/263,703, filed April 28, 2014 [E-109-2007/ 1-US-011] The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to in vitro diagnostics of prion- associated diseases requiring FDA premarket approval, or the equivalent thereof outside of the United States, and USDA licensed veterinary diagnostics, or the equivalents thereof outside of the United States.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0422, which expires on August 31, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Vaginal Microbicides: Development for the Prevention of HIV Infection.'' The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides. This guidance finalizes the draft guidance issued on November 23, 2012.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $125,000 as a single-source program expansion supplement to Casa de Esperanza in St. Paul, Minnesota. The grantee, funded under the FVPSA program, is a technical assistance provider that assists FVPSA service providers to build the capacity of domestic violence programs to serve Latina victims of domestic violence.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $150,000 as a single-source program expansion supplement to APIIDV in San Francisco, CA. The grantee, funded under the FVPSA program, is a technical assistance provider that assists FVPSA service providers to build the capacity of domestic violence programs to serve victims of domestic violence from Asian and Pacific Islander communities.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 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. 209 and 37 CFR Part 404 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 withdrawing approval of 14 new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rare Pediatric Disease Priority Review Vouchers.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section. These vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. These vouchers can be sold or transferred for use to another sponsor any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.

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 procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. The notice also invites comments on two new forms FDA is developing to allow manufacturers and distributors to submit this information electronically via FDA's Unified Registration and Listing System (FURLS).

This notice announces a 3-year Medicare Prior Authorization model for repetitive scheduled nonemergent ambulance transport in the states of New Jersey, Pennsylvania, and South Carolina where there have been high incidences of improper payments for these services.

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 research entitled, ``Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer (DTC) Prescription Drug Advertisements.'' This study will examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone through empirical research.

The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Food Advisory Committee. This meeting was announced in the Federal Register of August 19, 2014. The amendment is being made to add an ADDRESSES section and to reflect a change in the Agenda. There are no other changes.

This notice provides public announcement of CDC's intent to award Ebola appropriations to the International Association of National Public Health Institutes (IANPHI) for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1419 ``Advancing National Public Health Institutes Globally''. IANPHI is uniquely positioned, in terms of authority, ability, track record, infrastructure, and credibility to engage its member institutes to respond to the Ebola outbreak in West Africa. Furthermore, these activities to increase eligible governments' capacity to respond to the Ebola outbreak are directly aligned with the current activities that IANPHI is conducting under this FOA to strengthen and expand national public health institute capabilities and support global health security.

This major final rule with comment period addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. See the Table of Contents for a listing of the specific issues addressed in this rule.

NIMH is revising its 2008 Strategic Plan to guide the Institute's research efforts and priorities over the next five years (2015-2020). The purpose of this Notice is to seek input from the public about the draft NIMH 2015 Strategic Plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (https://www.nimh.nih.gov/about/strategic-planning-reports/rev iew-the- draft-2015-nimh-strategic-plan.shtml) for a 30-day period beginning on the publication date of this Notice. The public is invited to provide comments via the email address or postal address provided in this Notice and on the NIMH Draft Strategic Plan Web page.

The Food and Drug Administration (FDA) is announcing the availability of an environmental assessment filed by DSM Nutritional Products in support of their petition proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in vitamin D formulations, including 25-hydroxyvitamin D3, used in animal food.

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 research entitled, ``Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads.'' This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are making changes to the data sources permitted for expansion requests for physician-owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a formal process, including a three- level appeals process, to recoup overpayments that result from the submission of erroneous payment data by Medicare Advantage (MA) organizations and Part D sponsors in the limited circumstances in which the organization or sponsor fails to correct these data.

This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.

The Administration for Native Americans (ANA) invites public comment pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, which requires ANA to provide members of the public with the opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice that affect programs, projects, and activities authorized under the NAPA, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposal to fund projects, beginning in Fiscal Year (FY) 2015, under Alaska-Specific SEDS.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.'' This guidance specifies the UFI system for registration of domestic and foreign drug establishments. The guidance addresses provisions set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance finalizes the draft guidance issued on September 6, 2013.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for issuance of a new expiration date of a previously-approved information collection assigned OMB control number 4040-0014-SF-425 Federal Financial Report, which expires on February 28, 2015. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0012SF-270: Request for Advance or Reimbursement, which expired on October 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.