Department of Health and Human Services February 2017 – Federal Register Recent Federal Regulation Documents

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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 a public workshop regarding the current state and further development of animal models for serious infections caused by Acinetobacter baumannii and Pseudomonas aeruginosa. FDA is conducting this workshop in order to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, contract research organizations, and industry on various aspects of development efforts pertaining to animal models of serious infections. The input from this public workshop will also help FDA in developing topics for future discussion.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announces the availability of a draft web-based database entitled PPE-Info for public comment. To view the notice and related materials, visit www.regulations.gov and enter CDC-2017-0001 in the search field and click ``Search.''

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Area IV of the Santa Susana Field Laboratory in Ventura County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.

This proposed notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information necessary to determining grantee compliance with Title VII of the Rehabilitation Act of 1973, As Amended by the Workforce Innovation and Opportunity Act of 2014. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 proposed action. This notice solicits comments on a proposed revision to an existing data collection related to the Centers for Independent Living Program Performance Report (CIL PPR, formerly the Section 704 Part II Report).

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: 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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) to review again proposed information collection project: Pharmacy Survey on Patient Safety Culture Comparative Database.'' This proposed information collection was previously published in the Federal Register on November 18, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the new information collection Office of Management and Budget (OMB) Control Number 0917-NEW, titled, ``Mashpee Wampanoag Community Health Assessment.'' The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID [IHS-2017-0001]).

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 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.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6-7, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.

On September 29, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition to add autoimmune diseases, including rheumatoid arthritis, to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 014 is not substantially different from Petitions 007, 008, 009, 011, and 013, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator has published responses to the five previous petitions in the Federal Register and has determined that Petition 014 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including rheumatoid arthritis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug SubstancesQuestions and Answers (regarding the selection and justification of starting materials).'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances''. The draft guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The question-and-answer (Q&A) draft guidance focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and/or Master Files to justify the starting materials.

In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model'' published in the January 3, 2017 Federal Register (82 FR 180). That rule implements three new Medicare Parts A and B episode payment models and a Cardiac Rehabilitation (CR) Incentive Payment model, and implements changes to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act (the Act). Under the three new episode payment models, acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. Under the CR Incentive Payment model, acute care hospitals in certain selected geographic areas will receive retrospective incentive payments for beneficiary utilization of cardiac rehabilitation/intensive cardiac rehabilitation services during the 90 days following discharge from a hospitalization treatment of an acute myocardial infarction or coronary artery bypass graft surgery. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email OMH-ACMH@hhs.gov.

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 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.

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Dr. Raymond Sean Brown from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Brown was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Brown was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Brown failed to request a hearing. Dr. Brown's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule on Confidentiality of Substance Use Disorder Patient Records. That rule is scheduled to take effect on February 17, 2017. In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017 (82 FR 8346), this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Confidentiality of Substance Use Disorder Patient Records'' published in the Federal Register on January 18, 2017 (82 FR 6052).

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products.'' The purpose of the public meeting is to give interested persons an opportunity to discuss the use of the term ``healthy'' in the labeling of human food.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a change in the effective date of the final rule titled ``Control of Communicable Diseases'' that was published on January 19, 2017. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled ``Regulatory Freeze Pending Review.''

The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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 invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic difluprednate emulsion, entitled ``Draft Guidance on Difluprednate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for difluprednate emulsion.

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 ``The Re-Engineered Visit for Primary Care (AHRQ REV).'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of two 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services (HHS), Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

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). 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.samhsa.gov/workplace.

Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill.'' The purpose of the proposed study is to evaluate and characterize human exposure potential to constituents in crumb rubber infill.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Grants for Injury Control Research Centers Annual Progress Report (APR).'' CDC will collect information from grantees funded under Grants for Injury Control and Research Centers (ICRC) for the Annual Progress Report (APR). The APR is used to monitor the ICRCs' progress on set performance indicators, activities, and progress towards stated grant objectives.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is extending the period to submit comments responsive to the Request for Information, published in the Federal Register on January 9, 2017. The Request for Information (RFI) requests information from American Indian and Alaska Native (AI/AN) elected representatives, tribes, tribal organizations, and other stakeholder (including grantees) to identify issues and challenges facing AI/AN populations in order to inform ACF of tribes' and tribal organizations' recommendations, promising practices, and innovations to address the needs of AI/AN children, youth, families, and communities.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (the Secretary) 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 National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Microbiotix, Inc. (``Microbiotix'') located in Worcester, Massachusetts.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Fresenius Medical Care PSO, LLC of its status as a PSO, and has delisted the PSO accordingly. The Fresenius Medical Care PSO, LLC submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.