Department of Health and Human Services 2016 – Federal Register Recent Federal Regulation Documents

This notice announces the availability of test procedures and the Cypress version 3.0 test tool approved by the National Coordinator for Health Information Technology (the National Coordinator) for the testing of Health IT Modules to four 2015 Edition health information technology (health IT) certification criteria under the ONC Health IT Certification Program.

Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. The provisions contained herein provide additional clarity to various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.

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.

Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment, in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on a report entitled: Advancing the Care of Pregnant and Parenting Women with Opioid Use Disorder and their Infants: A Foundation for Clinical Guidance. The report is available at: https://www.regulations.gov/docket?D=SAMHSA-2016-0002. This report describes the formal process agreed on and followed under the guidance of the federal steering committee (FSC). It explains the RAND Corporation (RAND)/University of California Los Angeles (UCLA) Appropriateness Method (RAM), justifies its adoption, and reports the outcomes of its application that will form the basis for the development of clinical guidance. This report will serve as the foundation for the development of clinical guidance to be used by providers caring for women with opioid use disorder and their infants.

The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.

The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled ``Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,'' that appeared in the Federal Register of May 13, 2016. In the document, FDA requested comments on FDA's recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next generation sequencing-based diagnostic devices for microbial identification and detection of antimicrobial resistance and virulence markers. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

On May 1, 2015, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [80 FR 24930] announcing the availability of and a request for comments for the draft immediately dangerous to life or health (IDLH) values and support technical documents, entitled IDLH Values Profiles, for 14 chemicals. Written comments were to be received before the end of the comment period on June 30, 2015. Due to subsequent requests from the public, this Notice announces that NIOSH is seeking further comments on the draft IDLH Value Profile for peracetic acid (CAS #79- 21-0) https://www.cdc.gov/niosh/docket/review/docket156a/pdfs/g1-013 - peracetic-acid-cas-79-21-0.pdf for an additional 60 days.

The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Pursuant to 42 U.S.C. 300u, 42 U.S.C. 300u-2, and 42 U.S.C. 237a (Sec. 3509 of the Patient Protection and Affordable Care Act), notice is given that the Office on Women's Health (OWH) is soliciting award nominations in honor of its 25th anniversary from individuals and organizations for the following three awards: Partnership Award: The Partnership Award recognizes an outstanding partner organization of OWH. This organization has demonstrated a commitment to improving women's health and its efforts have resulted in measurable results that increased awareness about OWH, its initiative(s), or observance(s). Trailblazer Award: The Trailblazer Award recognizes an individual who has paved the way for advancement in women's health by being an innovator, a visionary, and a changemaker. The recipient of this award could include a researcher, advocate, or policymaker, and could be either a government or non-government employee. Emerging Leader Award: The Emerging Leader Award recognizes an individual in the early stages of their career who is already making a difference in women's health. The recipient of this award could include a researcher, advocate, or policymaker, and could be either a government or non-government employee.

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: ``Agency for Healthcare Research and Quality's (AHRQ) Guide To Improving Patient Safety in Primary Care Settings by Engaging Patients and FamiliesEvaluation.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed field survey to assess safety and health hazards to workers in oil and gas (O&G.) extraction.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed study to examine the facilitators and barriers to receiving clinical preventive services among newly insured medically underserved women who had previously been served by the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). The purpose of this survey is to assess if newly insured women receive appropriate clinical preventive health services, what barriers and facilitators these women experience, and if they are able to maintain consistent health insurance coverage.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Survey of Surveillance Records of Aedes aegypti and Aedes albopictus from 1960 to Present. This project consists of the collection of county and sub- county-level records for Aedes aegypti and Ae. albopictus, the vectors of Zika virus.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Information Collection for Tuberculosis Data from Referring Entities to CureTB. CureTB is intended to provide continuity of care for individuals affected by TB who enter US jurisdictions from foreign nations who or who leave US jurisdictions bound for foreign nations.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on July 26, 2016 for public comment.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.

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 purpose of this notice is to allow for an additional 30 days of public comment on the information collection requirements relating to the National Adult Maltreatment Reporting System (NAMRS). The proposed collection of information tools may be found in the NAMRS section of the ACL Web site.

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice of filing that appeared in the Federal Register of May 20, 2016 (81 FR 31877). In the notice, we requested comments on a filed food additive petition (FAP 6B4815), submitted by the Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science In The Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council, proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho-phthalates. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Ulcerative Colitis: Clinical Trial Endpoints.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance addresses FDA's current thinking regarding efficacy endpoints for UC clinical trials.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' FDA is issuing this draft guidance document to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. When finalized, this document will supersede ``Deciding When to Submit a 510(k) for a Change to an Existing Device'' issued January 10, 1997. This draft guidance is not final nor is it in effect at this time.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.

The Food and Drug Administration (FDA) is announcing the completion of the target of the goal established to address the Center for Devices and Radiological Health's (CDRH) 2014-2015 Strategic Priority ``Strike the Right Balance Between Premarket and Postmarket Data Collection.'' To achieve this Strategic Priority, CDRH established a goal to assure the appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance. We established a target date of December 31, 2015, by which to review 100 percent of product codes subject to a premarket approval application (PMA) that are legally marketed and were approved prior to 2010 to determine, for each such product code, whether or not, based on our current understanding of the technology, to reduce premarket data collection by relying more on postmarket controls, and whether to shift some premarket data collection to the postmarket setting or to pursue down-classification.

The Food and Drug Administration (FDA) is issuing a rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. FDA is issuing this action directly as a final rule because we believe there is little likelihood that we will receive any significant adverse comments opposing the rule given the specific deficiencies identified that will result in FDA's refusal to accept the submission.

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.

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) announces a forthcoming public advisory committee meeting of the National Mammography Quality Assurance Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled, ``Pediatric Master Protocols''. The objective of the workshop is to discuss regulatory and scientific concerns related to pediatric master protocols and clinical trial design considerations for these protocols. In addition, applications of pediatric master protocols to specific pediatric therapeutic areas will be presented.

This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.

This final rule will update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS's) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2017. This final rule also revises and updates quality measures and reporting requirements under the IRF quality reporting program (QRP).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling: Nutrition Facts and Supplement Facts Label and Reference Amounts Customarily Consumed Per Eating Occasion'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) announces its intent to award a non-competitive supplemental grant in the amount of up to $310,000 to the National Safe Place Network in Louisville, KY, to support and expand the grantee's 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 of a draft guidance for industry entitled ``Insanitary Conditions at Compounding Facilities.'' Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events in patients, including death. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.

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 Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in 6 states. The demonstration is being implemented in accordance with section 402 of the Social Security Amendments of 1967 and gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Medical X-Ray Imaging Devices Conformance With IEC Standards.'' This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA's regulations that apply to medical devices and electronic products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. This draft guidance is not final nor is it in effect at this time.

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, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. 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. Ofelia Olivero, Chief Intramural Diversity Workforce Branch, Center for Cancer Training, NCI, 9609 2W108, Rockville, MD 20850 or call non-toll- free number (240)276-6890 or Email your request, including your address to: oliveroo@exchange.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: NCI's Center for Cancer Training Application Form for Graduate Student Recruitment Program (CCT) (NCI), 0925-NEW National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Cancer Training (CCT) is supporting NCI's goal of training cancer researchers for the 21st century. To support that goal, CCT created a Graduate Student Recruitment Program (GSRP) with the purpose of recruiting outstanding young scientists to postdoctoral positions at the NCI. The proposed information collection involves brief online applications completed by applicants to the full time and summer curriculum programs. This information is essential to the program to determine the eligibility and quality of potential selected individuals. The information is for internal use to make decisions about candidates invited to visit NCI and interview with scientist as potential postdoctoral trainees. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 225.

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. The Advisory Council will hear from a number of CMS's HCIA awardees about their projects and their results. Additional presentations in the afternoon will include an overview of the 2016 Update to the National Plan, updates on progress towards a Care and Services Summit, and Federal workgroup updates.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' The purpose of this draft guidance is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. The draft guidance is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.

The Food and Drug Administration (FDA or Agency) has determined that SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal and regulatory requirements are met.

Pursuant to 42 U.S.C. 300u, 42 U.S.C. 300u-2, and 42 U.S.C. 237a (3509 of the Patient Protection and Affordable Care Act), notice is given that the Office on Women's Health (OWH) is soliciting proposals from non-federal public and private sector entities to co- sponsor the OWH Anniversary Celebration event in the Washington, DC area in late September, 2016.

The Food and Drug Administration (FDA or we) is extending the compliance date for certain requirements in the final rule requiring disclosure of calorie declarations for food sold from certain vending machines. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for reconsideration of the rule's requirements pertaining to the size of calorie disclosures on front-of-package labeling.

The Food and Drug Administration (FDA or we) 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 requesting that any industry organizations interested in participating in the selection of a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products (CTP), notify FDA in writing. FDA is also requesting nominations for a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

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 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.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``General Wellness: Policy for Low Risk Devices.'' The guidance is intended to provide clarity to industry and FDA staff on Center for Devices and Radiological Health's (CDRH) compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). By clarifying the policy on general wellness products, we hope to improve the predictability, consistency, and transparency on CDRH's regulation of these products. For purposes of the guidance, CDRH defines ``general wellness products'' as products which meet the following factors: They are intended for only general wellness use as defined in the guidance and present a low risk to the safety of users and other persons.

The Food and Drug Administration (FDA or we) is amending our regulations to reflect a change in the address for the Center for Food Safety and Applied Nutrition (CFSAN). This action is editorial in nature and is intended to improve the accuracy of our regulations.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

This meeting was announced in the Federal Register on July 14, 2016, 81 FR 45506. This meeting is canceled in its entirety.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2017 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2017.

The Food and Drug Administration (FDA or Agency) is establishing a public docket for comment on the Agency's blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry'' dated December 2015. Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2016, and will remain in effect through September 30, 2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' FDA is issuing this draft guidance to clarify how we evaluate real- world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an investigational device exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public to attend in person at the FDA White Oak campus in Silver Spring, MD. Members will participate via teleconference.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty-sixth meeting on August 31, 2016. At this meeting, the Commission will reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Well- Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System. The WISEWOMAN program aims to reduce cardiovascular disease in women ages 40-64 by providing screening services, referrals to medical care, and lifestyle intervention programs.

The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products.

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 Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on August 2, 2016, to solicit comments regarding the supplemental notice of proposed rulemaking, ``Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements.'' The session will be held in Rockville, MD, to obtain direct public input from stakeholders on the proposed reporting requirements.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhiyu Li, Ph.D., Mount Sinai School of Medicine: Based upon the evidence and findings of an investigation report by the Mount Sinai School of Medicine (MSSM) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Zhiyu Li, former Postdoctoral Fellow, MSSM, engaged in research misconduct in research that was supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R21 CA120017. ORI found that falsified and/or fabricated data were included in the following published papers, submitted manuscript, poster presentation, and grant applications:

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: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.