Department of Health and Human Services May 2018 – Federal Register Recent Federal Regulation Documents

Solicitation of Written Comments on the Human Papillomavirus Vaccination Implementation Work Group Draft Report and Draft Recommendations for Consideration by the National Vaccine Advisory Committee
Document Number: 2018-11745
Type: Notice
Date: 2018-05-31
Agency: Department of Health and Human Services
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act. Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in his capacity as the Director of the National Vaccine Program on matters related to vaccine program responsibilities. The ASH charged the NVAC in February 2018 to establish a work group to produce a brief report by June 2018 on recommendations to strengthen the effectiveness of national, state, and local efforts to improve Human Papillomavirus (HPV) coverage rates. Through a series of conference calls, electronic communication, and public discussion at the May 3, 2018, NVAC public meeting, the work group identified a number of draft recommendations for consideration by the NVAC. The work group's draft report and recommendations will inform NVAC deliberations as it finalizes recommendations for transmittal to the ASH. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in June 2018 at the quarterly NVAC meeting.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11725
Type: Notice
Date: 2018-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11724
Type: Notice
Date: 2018-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11722
Type: Notice
Date: 2018-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-11657
Type: Notice
Date: 2018-05-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 ``Nursing Home Survey on Patient Safety Culture Database.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-11648
Type: Notice
Date: 2018-05-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 an opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled StopAnthrax\TM\. This new generic clearance will support the collection of information from (1) persons exposed to an intentional release of anthrax that were given post- exposure prophylactic medical countermeasuresantibiotics or antibiotics and vaccine and (2) persons participating in points of dispensing (PODs) exercises conducted by state and local health departments. CDC will use this information to (1) inform response activities during an anthrax incident and (2) improve the StopAnthrax\TM\ program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
Document Number: 2018-11647
Type: Notice
Date: 2018-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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 the collection of information concerning the establishment and operation of clinical trial data monitoring committees.
Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability
Document Number: 2018-11642
Type: Notice
Date: 2018-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessment of Pressor Effects of Drugs.'' This guidance is intended to advise sponsors on the premarketing assessment of a drug's effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure may therefore be an important consideration in benefit-risk assessment.
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2018-11641
Type: Notice
Date: 2018-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance, which consists of a Core Guideline and an Annex, provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including marketed chemical and biotechnological/biological products.
Proposed Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
Document Number: 2018-11628
Type: Notice
Date: 2018-05-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requests comments on a plan to (1) revise the definition and characterization of Assisted Reproductive Technology (ART) success rates and (2) introduce clinic validation footnotes for the annual ART Fertility Clinic Success Rates Report. The footnotes will identify clinics that are selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and that: (1) Do participate, (2) do participate and have major data discrepancies identified through this process, and/or U3) decline to participate in the data validation process. CDC requests comments on this plan in order to continue to ensure that the public has access to accurate and transparent data pursuant to the Fertility Clinic Success Rate and Certification Act of 1992.
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2018-11619
Type: Notice
Date: 2018-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-11603
Type: Notice
Date: 2018-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo classification requests). This draft guidance is not final nor is it in effect at this time.
Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2018-11600
Type: Notice
Date: 2018-05-31
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will further develop recommendations regarding setting targets for the Healthy People 2030 objectives and recommendations regarding the role of law and policy, systems science, health literacy, health promotion, health and well-being, summary measures, and health equity in Healthy People 2030. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-11492
Type: Notice
Date: 2018-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2018-11563
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-11562
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-11561
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-11560
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-11559
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-11558
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11557
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11556
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Control of Communicable Diseases; Technical Correction
Document Number: 2018-11539
Type: Rule
Date: 2018-05-30
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a technical correction to the final rule published on July 10, 2017. The July 10, 2017, technical correction provided amendments to a final rule published on January 19, 2017, but contained an error. HHS/CDC is therefore submitting a new correction to correct that error.
Agency Information Collection Activities: Submission for Office of Management and Budget (OMB) Review; Comment Request
Document Number: 2018-11536
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-11491
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences Amended Notice of Meeting
Document Number: 2018-11490
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2018-11489
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Notice of Closed Meetings
Document Number: 2018-11488
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Notice of Closed Meeting
Document Number: 2018-11487
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Notice of Closed Meeting
Document Number: 2018-11486
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Notice of Closed Meeting
Document Number: 2018-11485
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11484
Type: Notice
Date: 2018-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
Document Number: 2018-11472
Type: Notice
Date: 2018-05-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality published a document in the Federal Register of May 11, 2018 regarding AHRQ Seeking Input on Library of Patient-Centered Outcomes Research Resources. This document contained an error and the deadline date has been extended.
Solicitation of Nominations for Membership to Serve on the Advisory Committee on Infant Mortality
Document Number: 2018-11465
Type: Notice
Date: 2018-05-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Infant Mortality (ACIM). ACIM provides advice to the Secretary of HHS on Department activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants.
Advisory Committee on Interdisciplinary, Community-Based Linkages
Document Number: 2018-11464
Type: Notice
Date: 2018-05-29
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) will hold a public meeting.
Registration of Food Facilities: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
Document Number: 2018-11419
Type: Notice
Date: 2018-05-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Registration of Food Facilities: What You Need To Know About the FDA Regulation Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of July 14, 2016, entitled ``Amendments to Registration of Food Facilities.'' The final rule amends the registration of food facilities regulations.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-11401
Type: Notice
Date: 2018-05-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection for Tuberculosis Data from Panel Physicians, which collects TB data gathered during overseas immigration medical exams.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-11400
Type: Notice
Date: 2018-05-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Applied Research to Address Emerging Public Health Priorities, a broad agency announcement for the competitive selection of research proposals.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-11399
Type: Notice
Date: 2018-05-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Behavioral Surveillance among Transgender women (NHBS-Trans). CDC is requesting a new 2-year approval to pilot collecting standardized HIV-related behavioral data from transgender women at risk for HIV systematically selected from 9 Metropolitan Statistical Areas (MSAs) throughout the United States.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-11360
Type: Notice
Date: 2018-05-29
Agency: Department of Health and Human Services, 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 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.
Medicare Program; Announcement of the Reapproval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2018-11330
Type: Notice
Date: 2018-05-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of the Joint Commission for reapproval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the Joint Commission meets or exceeds the applicable CLIA requirements. We are announcing the reapproval and grant the Joint Commission deeming authority for a period of 6 years.
Advisory Commission on Childhood Vaccines
Document Number: 2018-11298
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold a public meeting. This meeting will be open to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Document Number: 2018-11281
Type: Notice
Date: 2018-05-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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 the information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.
Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines
Document Number: 2018-11258
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
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 Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan.
Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines
Document Number: 2018-11257
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
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 to Fundacao Butantan, having a place of business in Sao Paulo, Brazil.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-11256
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-11255
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-11220
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-11216
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-11215
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health