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

The Administration for Community Living (ACL), Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information. 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 relating to the Evidence-Based Falls Prevention Program.

This proposed notice acknowledges the receipt of an application from Det Norske Veritas Healthcare (DNVHC) for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.

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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award up to $1,448,432 (total costs) for one year to Link2Health Solutions, Inc., as a program supplement to the National Suicide Prevention Lifeline. The purpose of this program is to provide national telephonic access at any time of the day or night to suicide prevention and crisis intervention services through toll-free suicide prevention hotline numbers, including 1-800-273-TALK (8255). Supplemental funding is being provided for the National Suicide Prevention Lifeline to expand and enhance the currently funded chat and text-based SMS services from 12 hours a day to 24/7 coverage. The Lifeline will continue awareness raising activities such as, but not limited to, social media engagement and promotion of services that will continue to be directed towards the suicide prevention needs of high-risk populations identified by the National Action Alliance for Suicide Prevention; lesbian, gay, bisexual, or transgender (LGBT) youth, American Indian/Alaska Native (AI/AN), military family members and veterans, and suicide attempt survivors. These services directly support the objectives of the National Strategy for Suicide Prevention. Funding Opportunity Title: SM-14-021. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling 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 or we) is announcing the availability of a guidance entitled ``Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.'' This guidance explains FDA's current thinking on determining whether FDA-regulated products involve the application of nanotechnology. The guidance identifies two Points to Consider, which address both particle dimensions and dimension-dependent properties or phenomena. If either point applies to a given product, industry and FDA should consider whether evaluations of safety, effectiveness, public health impact, or regulatory status of that product have identified and adequately addressed any unique properties or behaviors of the product. These two Points to Consider are intended to provide an initial screening tool that can be broadly applied to all FDA-regulated products, with the understanding that these points are subject to change in the future as new information becomes available.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ``Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.'' The guidance explains FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affect the identity of the food substance, impact the safety of the use of the food substance, change the regulatory status of the use of the food substance, or warrant a new regulatory submission to FDA.

In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration's (FDA) regulations for the protection of privacy, FDA is deleting four system of records notices (SORNs) from its existing inventory of SORNs and adding routine uses to the remaining SORNs. The systems related to the SORNs that are being deleted are no longer in use by FDA. The additional routine uses are for standard disclosures common to systems across the government. They allow disclosure to other Federal Agencies and contractors as needed to respond to a breach of system security or confidentiality, to contractors or other external individuals performing work for FDA that requires access to Agency records subject to the Privacy Act, to Federal record keeping authorities for the purpose of records management oversight, to appropriate public authorities when a record indicates a potential violation of law, and to the U.S. Department of Justice (DOJ) for guidance on Freedom of Information Act issues. FDA will require that all of these recipients comply with the requirements of the Privacy Act. The added routine uses will be inserted in each existing system notice and will be included in future FDA SORNs.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff.'' This guidance finalizes, as a single document, all sections of, ``Global Unique Device Identification (GUDID): Draft Guidance for Industry.'' The guidance includes, with minor modifications, the previously finalized sections on how device labelers will interface with the GUDID, establish GUDID accounts and begin initial submissions. The guidance also finalizes the sections on the Device Identifier (DI) record, Health Level 7 Structured Product Labeling (HL7 SPL) submission, search/retrieval of devices information, and GUDID submissions and maintaining and submitting electronic records. The guidance also finalizes Appendix AGUDID Package Information Examples.

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 document corrects a notice that was published in the Federal Register on June 6, 2014 (79 FR 32737-32738). The time and date should read as follows: Time and Date: 9:30 a.m.-3:30 p.m., June 19, 2014 (Closed). For Further Information Contact: Gwendolyn H. Cattledge, Ph.D., M.S.E.H., F.A.C.E., Deputy Associate Director for Science, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE., Mailstop F63, Atlanta, Georgia 30341, Telephone: (770) 488-4655, GXC8@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Gluten-Free Labeling of FoodsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of August 5, 2013, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice advises the public of the published lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 23, 2014, available on the Health Resources and Services Administration (HRSA) Web site at https:// www.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.

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.

These final regulations clarify the maximum allowed length of any reasonable and bona fide employment-based orientation period, consistent with the 90-day waiting period limitation set forth in section 2708 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act (Affordable Care Act), as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.'' FDA is issuing this document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health. In this document, FDA is also proposing changes to its guidance entitled ``Mobile Medical Applications,'' issued on September 25, 2013, to conform to the proposed policy discussed in this draft guidance document. This draft guidance is not final nor is it in effect at this time.

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 public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July meeting, the Advisory Council will review and discuss its recommendations on informal caregiving, hear presentations on statistics about caregivers and existing programs to provide them with help, and hear presentations from the four subcommittees (Research, Clinical Care, Long-Term Services and Supports, and Ethics). The Advisory Council will also discuss the G7 Dementia Summit that was held on June 19th, 2014 in the UK.

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 Secretary of the Department of Health and Human Services has renewed the charter of the National Preparedness and Response Science Board (NPRSB), previously known as the National Biodefense Science Board, for an additional two-year period through July 3, 2016.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Melanie Cokonis, Southern Research Institute: Based on the report of an investigation conducted by Southern Research Institute (SRI) and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Melanie Cokonis, former Research Technician, SRI, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), contracts N01-AI-30047 (HHSN2722011000009C) and N01-AI-70042 (HHSN272200700042C), and National Human Genome Research Institute (NHGRI), NIH, grant U54 HG005034. ORI found that the Respondent engaged in research misconduct by falsifying assay data that were submitted in reports to NIH. Specifically, ORI found that Respondent knowingly falsified data for cytoprotection assays with antiviral compounds and provided the false data for inclusion in reports submitted to NIH for contracts N01-AI- 30047 and N01-AI-70042 and grant U54 HG005034. Respondent transferred raw data from 8X12 SoftmaxPro matrix files into spreadsheets and then falsified the numbers for cell control, virus control, drug cytotoxicity, drug only, and/or cells+ virus+ drug wells to make 206 assays appear to have been successfully performed when they were not. Ms. Cokonis has voluntarily agreed for a period of three (3) years, beginning on May 29, 2014: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) To exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Arbor Vita Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

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 or we) received applications for temporary permits from Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants). We are announcing that we have issued temporary permits to the applicants to market test products (designated as ``canned tuna'' products) that deviate from the U.S. standard of identity for canned tuna. The purpose of the temporary permits is to market test the product throughout the United States and the Commonwealth of Puerto Rico. The permits will allow the applicants to measure consumer acceptance of the products and assess the commercial feasibility of the products.

The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the proposed collection of information listed below 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 ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. Submitted information will be used to assess the state of the science and determine the technical needs for a dynamic nonanimal system to assess the potential toxicity of inhaled chemicals and nanomaterials.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), 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: Seminara, Daniela, Senior Scientist and Cohort and Consortia Coordination Team Lead, Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276-6748 or Email your request, including your address to: seminard@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

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 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 a new collection. 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 announcing the availability of a draft guidance for industry entitled ``Internet/ Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.'' This draft guidance responds to, among other things, stakeholder requests for specific guidance and describes FDA's current thinking on how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices), including biological products, that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling of their FDA- regulated medical products on electronic/digital platforms that are associated with character space limitations, specifically on the Internet and through social media or other technological venues (Internet/social media). The draft guidance represents FDA's current thinking on specific aspects of FDA's evolving consideration of social media platforms and other Internet-related matters. FDA continues actively to review, analyze, and develop approaches to a variety of topics related to the labeling and advertising of medical products, including the development of this and other guidance addressing the use of social media platforms and the Internet.

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a wheelchair elevator device commonly known as a manually operated portable wheelchair lift. This device is used to provide a means for a disabled person to move a wheelchair from one level to another. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Health and Human Services has 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.).

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: ``Evaluation of the Educating the Educator (EtE) Workshop.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 28th, 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2014. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.

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 a new collection. 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.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR, titled ``CMS Encounter Data System (EDS)'', System No. 09-70-0506. CMS intends to collect encounter data, or data on each item or service delivered to enrollees of Medicare Advantage (MA) plans offered by MA organizations as defined at Title 42, Code of Federal Regulation (CFR), Sec. 422.4. Pursuant to 42 CFR 422.310, each MA organization must submit encounter data to CMS that is used to determine the risk adjustment factors for payment, updating the risk adjustment model, calculating Medicare Disproportionate Share Hospital (DSH) percentages, Medicare coverage purposes, and quality review and improvement activities. Encounter data will be collected and maintained in the EDS. Under the authority granted in Section 1115 of the Social Security Act (the Act), CMS is authorized to conduct experimental, pilot or demonstration projects. CMS is conducting a demonstration project under the Financial Alignment Initiative to test a new capitated payment system and item/ service delivery model designed to lower costs and improve the quality of care for individuals eligible for both Medicare and Medicaid (dual eligibles). CMS and the participating State Medicaid agency jointly contract with health plans (known as Medicare-Medicaid Plans or ``MMPs''). MMPs are paid monthly on a capitated basis and are required to submit to CMS comprehensive encounter data on each item or service provided to each enrollee, including both Medicare and Medicaid items and services. The program and the SOR are more thoroughly described in the Supplemental Information section and System of Records Notice (SORN), below.

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 communication studies involving FDA- regulated products intended for use in animals. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The Food and Drug Administration (FDA) has determined that LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 milliliter (mL), 10 mL total fill volume, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, if all other legal and regulatory requirements are met.

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 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 correcting a notice entitled ``Independent Assessment of the Process for the Review of Device Submissions; Final Comprehensive Findings and Recommendations and First Implementation Plan'' that appeared in the Federal Register of May 29, 2014 (79 FR 30853). The document announced Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their independent assessment of the process for the review of medical device submissions as well as FDA's first implementation plan based on Booz Allen Hamilton's high priority recommendations issued December 11, 2013. The notice was issued earlier than intended. The documents will be available on June 11, 2014, as required by the Medical Device User Fee Amendments of 2012 (MDUFA) III Performance Goals and Procedures Commitment Letter.

The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of August 8, 2011, and the proposed order the Agency issued in the Federal Register of April 4, 2013, in part. In those documents, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, cranial electrotherapy stimulator (CES). In response to information received in response to these two proposed actions, FDA is withdrawing the proposed rule and proposed order.

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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects 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: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: glynnsa@nhlbi.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: HIV Study in Blood Donors from Five Chinese Regions, 0925-0596 reinstatement with change, National Heart, Lung and Blood Institute (NHLBI). Need and Use of Information Collection: This Study is a reinstatement of OMB Number: 0925-0596 expiration date, January 31, 2012. To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). The major objectives of the study will be to evaluate the proportion of blood donors in China who test positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV-1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status. The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad cross-section of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, the study objectives have direct relevance for HIV control in the U.S. and globally. Recent years have seen an increase in blood donations from repeat donors in most Chinese regions. This increase permits longer-term follow-up and testing of repeat donors which allow for calculation of new HIV infection rates and residual risks. The HIV data, for both recently and remotely acquired infections, from the proposed study will complement existing data on HIV risks obtained from general and high risk populations to provide comprehensive HIV surveillance data for China. This study will also monitor genetic characteristics of recently acquired infections through genotyping and drug resistance testing, thus serving a U.S. and global public health imperative to monitor the genotypes of HIV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Genotyping and host response information are scientifically important not only to China, but to the U.S. and other nations since they provide a broader global understanding of how to most effectively manage and potentially prevent HIV, for example through vaccine development. Efforts to develop vaccines funded by the National Institutes of Health and other U.S.-based organizations may directly benefit from the findings of this study. Blood donors are tested for transfusion-transmissible infections including HIV when they present to donate, and test result information as well as demographic data will be routinely collected in a database at the five blood centers participating in REDS-III studies (located in the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These data will allow for calculation of HIV incidence, prevalence, and residual risk. Additionally, a case-control study will be conducted over a 2 and 1/2 year period to evaluate the risk factors associated with HIV infection among blood donors. Cases will be defined as potential donors who deny risks on the donor screening questionnaire but are found to be positive on HIV testing (their donation is discarded). HIV-positive donors who gave blood at one of the five blood centers as stated above (primary sites) or at blood centers located in the Guangxi Autonomous Region (peripheral sites, recruited through the Guangxi CDC for this study only but not other REDS-III studies) will be eligible to participate and complete a Risk Factor Questionnaire that will assess general demographic and risk factor information pertinent to HIV infection. Controls will be negative for HIV on confirmatory testing. Assuming 50% response rate, it is anticipated that 390 HIV- positive donors and 960 controls will participate in the case control study. The results of this study will contribute to global HIV surveillance and prevention, provide a broader global understanding of HIV epidemiology, and support public health efforts to most effectively manage and potentially prevent HIV transmission both worldwide and in the U.S. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 450.