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

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Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-28604
Type: Notice
Date: 2016-11-29
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 guidance entitled ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' Flexible gastrointestinal endoscopes and accessories are class II devices and identified with product codes such as FDF, FDS, and OCX. When using these devices during an entire day of procedures (e.g., colonoscopies), clinicians typically use one irrigation system (i.e., one water bottle, one set of tubing and valves, etc.) without cleaning and sterilizing all the system components between patients. This guidance highlights the cross-contamination risk associated with day-use of irrigation systems used with flexible gastrointestinal endoscopes; clarifies terminology used to describe these devices; and outlines strategies to mitigate the risk of cross-contamination between patients during these procedures.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-28588
Type: Notice
Date: 2016-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
Document Number: 2016-28582
Type: Rule
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget
Document Number: 2016-28569
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Announcement of Requirements and Registration for “Storytelling About Health and Wellness in American Indian and Alaska Native Communities” Challenge
Document Number: 2016-28497
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
In recognition of Native American Heritage Month, the Tribal Health Research Office in the Division of Program Coordination, Planning, and Strategic Initiatives, in the Office of the Director of the National Institutes of Health (NIH), announces the ``Storytelling about Health and Wellness in American Indian and Alaska Native Communities'' Challenge. The goal of this Challenge is to develop a brief digital story (i.e., a video) that communicates how traditions and heritage promote health in American Indians and Alaska Natives (AI/ AN).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28496
Type: Notice
Date: 2016-11-28
Agency: Substance Abuse and Mental Health Services Administration, Department of Health and Human Services
Decision To Evaluate a Petition To Designate a Class of Employees From Metals & Controls Corp. in Attleboro, Massachusetts, To Be Included in the Special Exposure Cohort
Document Number: 2016-28480
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from Metals & Controls Corp. in Attleboro, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-28470
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Committee on Interdisciplinary, Community-Based Linkages
Document Number: 2016-28469
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that a meeting is scheduled for Advisory Committee on Interdisciplinary, Community- Based Linkages (ACICBL). This meeting will be open to the public. Information about the ACICBL and the agenda for this meeting can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/bhpradvisory/acicbl/. The agenda will be available 2 days prior to the meeting on the HRSA Web site listed above.
Notice of Listing of Members of the Food and Drug Administration's Performance Review Board
Document Number: 2016-28452
Type: Notice
Date: 2016-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42 SES Equivalents performance appraisals, bonus recommendations, and pay adjustments.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program
Document Number: 2016-28443
Type: Notice
Date: 2016-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Document Number: 2016-28442
Type: Notice
Date: 2016-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report containing additional information and analyses on the status of PMRs and PMCs is available on FDA's Web site.\1\
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28434
Type: Notice
Date: 2016-11-28
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 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-28433
Type: Notice
Date: 2016-11-28
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 (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.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-28431
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-28417
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-28416
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2016-28415
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guideline Update-CDC Recommendations on Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections
Document Number: 2016-28385
Type: Notice
Date: 2016-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on the Draft Update of CDC Recommendations on Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections (Draft Recommendation Update). The Draft Recommendation Update addresses new and updated strategies for the prevention of intravascular catheter- related infections in healthcare settings. CDC is providing a supporting appendix in the docket that includes primary evidence, study evaluation, and data evaluation tables that were used in developing the Draft Recommendation Update.
Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability
Document Number: 2016-28334
Type: Notice
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled ``Draft Guidance on Cyclobenzaprine Hydrochloride.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules.
Uniform Compliance Date for Food Labeling Regulations
Document Number: 2016-28333
Type: Rule
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is establishing January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments
Document Number: 2016-28332
Type: Notice
Date: 2016-11-25
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 revised draft guidance for industry entitled ``Submission of Quality Metrics Data.'' In order to help develop compliance and inspection policies and practices, improve the Agency's ability to predict, and therefore possibly mitigate, future drug shortages, and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing, FDA intends to initiate a quality metrics reporting program. The revised draft guidance describes FDA's plans for an initial, voluntary phase of this program. FDA expects that this voluntary phase will allow the Agency to learn more about a limited set of quality metrics and associated analytics, and to help inform future FDA decisionmaking about its quality metrics program. This revised draft also provides an opportunity to gain additional perspectives from industry participants on the future use of quality metrics data.
Request for Nominations on the Blood Products Advisory Committee
Document Number: 2016-28306
Type: Notice
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. 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.
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2016-28303
Type: Notice
Date: 2016-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-28302
Type: Notice
Date: 2016-11-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-28301
Type: Notice
Date: 2016-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Food Labeling
Document Number: 2016-28367
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
Food Labeling
Document Number: 2016-28364
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
Food Labeling
Document Number: 2016-28363
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-28225
Type: Notice
Date: 2016-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28211
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Request for Nominations of Potential Reviewers To Serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)
Document Number: 2016-28207
Type: Notice
Date: 2016-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Breast Cancer in Young Women, Centers for Disease Control and Prevention: Notice of Charter Renewal
Document Number: 2016-28206
Type: Notice
Date: 2016-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28155
Type: Notice
Date: 2016-11-23
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: ``The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Patient-Centered Medical Home (PCMH) Items Demonstration Study.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 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.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-28149
Type: Notice
Date: 2016-11-23
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: 2016-28148
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended Notice of Meeting
Document Number: 2016-28146
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-28145
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2016-28144
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-28143
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-28142
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-28141
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability
Document Number: 2016-28124
Type: Notice
Date: 2016-11-23
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 for industry entitled ``Nonprescription Sunscreen Drug ProductsSafety and Effectiveness Data.'' This guidance addresses FDA's current thinking on the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that the Agency anticipates adopting in the future.
Contract Manufacturing Arrangements for Drugs: Quality Agreements; Guidance for Industry; Availability
Document Number: 2016-28122
Type: Notice
Date: 2016-11-23
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 for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.
Nonprescription Sunscreen Drug Products-Format and Content of Data Submissions; Guidance for Industry; Availability
Document Number: 2016-28121
Type: Notice
Date: 2016-11-23
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 for industry entitled ``Nonprescription Sunscreen Drug ProductsFormat and Content of Data Submissions.'' This guidance addresses FDA's current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally recognized as safe and effective (GRASE), as provided under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA).
Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
Document Number: 2016-28120
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.
Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments
Document Number: 2016-27950
Type: Notice
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would help us evaluate the beneficial physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods. We are requesting such scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ``dietary fiber'' for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label.
Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Availability
Document Number: 2016-27949
Type: Proposed Rule
Date: 2016-11-23
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 draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health.
Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director)
Document Number: 2016-28140
Type: Notice
Date: 2016-11-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2016, page 56667 (81 FR 56667) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
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