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

The Food and Drug Administration (FDA), Office of International Programs (OIP) is announcing the availability of grant funds for the support of a single source cooperative agreement to the Pan American Health Organization (PAHO) for fostering cooperation and strengthening medical product regulatory systems in the Americas. The goal of the cooperative agreement is to build upon existing cooperation between OIP/FDA and PAHO to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas.

The Food and Drug Administration (FDA) published a document in the Federal Register of March 10, 2014 (79 FR 13263), providing notice of a petition filed by Kemin Industries, Inc., that proposed the food additive regulations be amended to provide for the safe use of chromium propionate as a source of chromium in broiler feed. That petition included an environmental assessment which was not noted in the March 10 notice of petition.

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 proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.

This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective January 1, 2015. As required by the Affordable Care Act, this rule implements the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments and the Affordable Care Act mandated face-to-face encounter requirement. This rule also proposes: Changes to simplify the face-to- face encounter regulatory requirements; changes to the HH PPS case-mix weights; changes to the home health quality reporting program requirements; changes to simplify the therapy reassessment timeframes; a revision to the Speech-Language Pathology (SLP) personnel qualifications; minor technical regulations text changes; and limitations on the reviewability of the civil monetary penalty provisions. Finally, this proposed rule also discusses Medicare coverage of insulin injections under the HH PPS, the delay in the implementation of ICD-10-CM, and solicits comments on a HH value-based purchasing (HH VBP) model.

HRSA will be issuing non-competitive awards under the Ryan White HIV/AIDS Program, AETC/GME Program. Approximately $450,000 will be made available in the form of a grant to current grantees (listed in chart below) during the budget period of July 1, 2014, through June 30, 2015. This will: (1) Continue the current cohort and provide support for one additional cohort of graduate medical residents; (2) continue to provide workforce development that is integral to the national interest through meeting National HIV/AIDS Strategy goals, and that enhances the implementation of the Affordable Care Act; and (3) provide a more robust program evaluation that will yield sufficient data; and aid HRSA/HAB in future decisions regarding the replication and the viability of a subsequent GME competition. The scope of work does not change.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following web-based public meeting and request for public comment on the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) and also announces the availability of a report entitled ``NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) Progress Report and Proposed Future Directions2014'' which is now available for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2014- 0010 in the search field and click ``Search.''

Eunice Kennedy Shriver National Institute of Child Health and Human Development, 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: Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-1877 or Email your request, including your address to glavins@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 (NICHD), 0925-0643, Expiration Date 10/31/2014, EXTENSION, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: There are no changes being requested 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, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide information about the NICHD'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 NICHD 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 NICHD's services will be unavailable. The NICHD 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 4,950.

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 (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 export notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco that may not be marketed or sold in the United States.

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache 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 transcutaneous electrical nerve stimulator to treat headache 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 Department of Health and Human Services published a notice in the Federal Register, dated June 17, 2014, to announce a meeting of the Advisory Committee on Minority Health that will be held on Tuesday, July 8, 2014, from 9 a.m. to 5 p.m., and on Wednesday, July 9, 2014, from 9 a.m. to 4 p.m. The meeting is scheduled to be held at the Omni Shoreham Hotel, 2500 Calvert Street NW., Washington, DC 20008. The posted meeting times have been changed.

In the October 30, 2013 issue of the Federal Register (78 FR 65046), we published a final rule entitled, ``Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014.'' The effective date was December 30, 2013. This correcting amendment corrects technical and typographical errors identified in the October 30, 2013 final rule.

The Food and Drug Administration (FDA or Agency) is preparing to develop a list of bulk drug substances (active ingredients) that may be used to compound drug products in accordance with section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) concerning outsourcing facilities. In response to a notice published in the Federal Register of December 4, 2013, interested groups and individuals previously nominated a wide variety of substances for this list. However, many of those nominations were not for bulk drug substances used in compounding as active ingredients, and none included sufficient information to justify inclusion of the nominated substances on the list. To improve the efficiency of the process for developing the list of bulk drug substances that may be used to compound drug products under section 503B of the FD&C Act, FDA is providing more detailed information on what it needs to evaluate a nomination. Because the deadline for nominations has passed, FDA is reopening the nomination process so that interested persons can submit nominations of bulk drug substances and provide adequate support to justify placing the substances on the list. Bulk drug substances that were previously nominated will not be further considered unless they are renominated and adequately supported. Substances that are not adequately supported will not be placed on the list.

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. Specifically, the proposed rule would add 25 drug products to this list of drug products and modify the description of one drug product on this list to add an exception. These revisions are necessary because new information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule. FDA is also withdrawing the previous proposed rule regarding additions to this list (see the Federal Register of January 4, 2000).

The Food and Drug Administration (FDA or Agency) is preparing to develop a list of bulk drug substances (active ingredients) that may be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. In response to a notice published in the Federal Register of December 4, 2013, interested groups and individuals previously nominated a wide variety of substances for this list. However, many of those nominations either were for a substance that is already the subject of a USP monograph or a component of an FDA-approved drug, were not for bulk drug substances used in compounding as active ingredients, or did not include sufficient information to justify inclusion of the nominated substance on the list. To improve the efficiency of the process for developing the list of bulk drug substances that may be used to compound drug products under section 503A, FDA is providing more detailed information on what it needs to evaluate a nomination. Because the deadline for nominations has passed, FDA is reopening the nomination process so that interested persons can submit nominations of bulk drug substances that are not the subject of a USP or NF monograph or a component of an FDA-approved drug. Interested persons will also have the opportunity to provide adequate support to justify placement of the substances on the list. Bulk drug substances that were previously nominated will not be further considered unless they are renominated and those nominations are adequately supported. Substances that are already eligible for use in compounding or that are not adequately supported will not be placed on the list.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine and to reflect the reformulation of the Type A medicated article as a two-way, fixed-ratio, combination drug product without penicillin.

The National Institutes of Health (NIH), Office of the Director, Office of Science Policy, and the Food and Drug Administration (FDA), Office of the Commissioner, are announcing a public workshop titled ``The Development of New Antibacterial Products: Charting a Course for the Future.'' The workshop is being held to: (1) Examine key issues and challenges related to antibacterial product development, (2) discuss regulatory pathways for bringing new antibacterial drugs to market, (3) identify strategies for promoting clinical trials for antibacterial drugs, and (4) encourage partnerships to accelerate the development of new antibacterial drugs. The workshop is open to the public and is free of charge.

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 seeking public comments on its draft Strategic Priorities Fiscal Year (FY) 2014-2018 document. FDA has identified these cross-cutting strategic priorities and core mission goals that will guide its efforts to achieve its public health mission. FDA is seeking public comment to help further refine these priorities and goals.

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

The Food and Drug Administration (FDA) is confirming the effective date of July 30, 2014, for the final rule that appeared in the Federal Register of March 17, 2014. The direct final rule amends the regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change ensures that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It also permits more timely public disclosure of approval-related information, increasing the transparency of FDA decisionmaking in the approval of new animal drugs. This document confirms the effective date of the direct final rule.

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 Administration for Community Living (ACL) is announcing 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.

This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. A hospital that participates in Medicaid must also meet the Medicare conditions of participation (CoPs) as required under section 1905(a) of the Social Security Act (``Act'') and 42 CFR 482.1(a)(5). This approval is effective July 15, 2014 through July 15, 2020.

This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.

In the March 11, 2014 issue of the Federal Register (79 FR 13744), we published a final rule entitled, ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2015.'' The effective date was May 12, 2014. This correcting amendment corrects a technical error identified in the March 11, 2014 final rule.

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 Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award up to $1,182,918 (total costs) for one year to the Education Development Center, Inc., Waltham, MA, as a program supplement to the Suicide Prevention Resource Center. The purpose of this program supplement is to support high-impact objectives of the National Strategy for Suicide Prevention (NSSP), provide technical assistance for NSSP implementation, and develop an implementation plan for preventing suicide among men in mid-life, with the overall goal of reducing suicides and suicidal behaviors in the nation. This supplement represents an enhancement of the SPRC's capacity to carry out its primary mission of advancing implementation of the NSSP. Funding Opportunity Title: SM-14-022. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' 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 for industry entitled ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The guidance represents our current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to help industry identify the potential safety issues of nanomaterials in cosmetic products and develop a framework for evaluating them.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI 220) entitled ``Use of Nanomaterials in Food for Animals.'' The draft guidance describes FDA's current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. It is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.

The Food and Drug Administration (FDA) has determined the regulatory review period for VICTRELIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Interventions to Improve Appropriate Antibiotic Use for Acute Respiratory Tract Infections, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

This document corrects a notice that was published in the Federal Register on June 12, 2014 (79 FR 33755). This meeting is cancelled in its entirety. Contact Person for More Information: M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-3585, EEO6@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) 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 requirement for an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

The Health Resources and Services Administration (HRSA) will issue a non-competitive program expansion supplement to up to 115 Ryan White HIV/AIDS Part D program grantees to support interventions that will positively impact the HIV health outcomes of women, infants, children, and youth in communities where Part D grantees are located. HRSA will provide such one-time program expansion supplemental awards for Part D grantees, in an amount not to exceed the lesser of $150,000 or 25 percent of each fiscal year (FY) 2014 grant award.

The Health Resources and Services Administration (HRSA) will be issuing non-competitive awards for the HCOP program. Approximately $9.8 million will be made available in the form of grants to the awardees listed in the chart below for the budget period beginning September 1, 2014. We have determined the need for significant program changes prior to launching a new competition to the field. This will enable the Bureau of Health Workforce to thoughtfully redesign the current program to ensure that it meets the needs of both the government and the field, and conduct a single competition in fiscal year (FY) 2015.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on proposed updated vaccine information materials for tetanus/diphtheria vaccine (Td), tetanus/diphtheria and acelullar pertussis vaccine (Tdap), Haemophilus influenzae type b (Hib) vaccine, and rotavirus vaccine.

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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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 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 its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2014 (FY14) to the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF).

The National Toxicology Program (NTP) announces a public webinar, ``Lessons Learned in Application of the Office of Health Assessment and Translation (OHAT) Framework for Systematic Review and Evidence Integration to Case Studies.'' The OHAT, Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) will host the web-based meeting and the public can register to participate at https://ntp.niehs.nih.gov/go/41629.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces a workshop on ``Adverse Outcome Pathways: From Research to Regulation.'' The workshop proposes to initiate stakeholder interaction and collaboration to enhance scientific development of the Adverse Outcome Pathway (AOP) concept with the goal of improving regulatory assessment of chemical toxicity. Registration is requested for attendance and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/ 41374.

The National Center for Advancing Translational Sciences (NCATS) and its collaborator, the University of Delaware, are seeking Cooperative Research and Development Agreement (CRADA) partners to collaborate in the final stages of lead optimization, evaluation and preclinical development of a novel series of selective and potent small-molecule inhibitors of the human USP1/UAF1 complex(1) for the treatment of cancer. Interested potential CRADA partners will receive detailed information about the project after signing a confidential disclosure agreement (CDA) with NCATS and University of Delaware.

The Food and Drug Administration (FDA) is extending the comment period for a proposed rule that appeared in the Federal Register of April 25, 2014. In the proposed rule, FDA requested comments, including comments on FDA's proposed options for regulation of cigars, regulatory approach to electronic cigarettes and other non- combustible tobacco products, pathways to market for proposed deemed tobacco products, and compliance dates for certain provisions, among other issues. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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 announcing the availability of a draft document entitled ``Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products'' dated June 2014. The draft guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA), or a supplement to a BLA, with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what sponsors and applicants can expect once an EA is filed. The guidance, when finalized, will supplement the guidance entitled ``Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications,'' dated July 1998 (1998 Guidance) and will also supersede those recommendations for GTVVs in section IV.B.1 Assessing Toxicity to Environmental Organisms'' of the guidance.

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2013 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2013. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/ sites/default/files/omb/procurement/memo/service-contract-inv entories- guidance-11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https:// www.hhs.gov/grants/servicecontracts.

The National Toxicology Program (NTP) announces a symposium on ``Assessing Exposures and Health Effects Related to Indoor Biomass Fuel Burning.'' The symposium will bring together researchers working in the area of indoor biomass fuel burning emissions and health effects to discuss the latest science, policy, and future directions. The meeting is open to the public. Registration is requested for attendance and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/41613.

The Food and Drug Administration (FDA) is withdrawing approval of 86 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 25, 2014 (Vol. 79, No. 57, pages 16345-16347). 3 comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))'' 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 Agency) is announcing the availability of a draft guidance for industry entitled ``Internet/ Social Media Platforms: Correcting Independent Third-Party Misinformation About 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, should respond, if they choose to respond, to misinformation related to a firm's own FDA-approved or cleared products when that information is created or disseminated by independent third parties. This draft guidance updates and clarifies FDA's policies on the correction of misinformation created or disseminated by independent third parties on the Internet or through social media platforms, regardless of whether that misinformation appears on a firm's own forum or an independent third-party forum or Web site. 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 issuing a final order to reclassify the blade-form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is revising the classification of blade-form endosseous dental implants.

The Food and Drug Administration (FDA or we) is reopening the comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of March 26, 2014. In the advance notice of proposed rulemaking, FDA solicited comments, data, and information to assist the Agency in implementing the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.