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

Results 1 - 50 of 3,146
Meeting of the Advisory Committee on Minority Health
Document Number: 2017-28161
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) 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. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-28159
Type: Notice
Date: 2017-12-29
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 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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-28157
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-28156
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-28155
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-28154
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-28153
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
Document Number: 2017-28140
Type: Notice
Date: 2017-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (hereafter referred to as products). The previous guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009, and the draft guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' published March 11, 2015, have been withdrawn.
Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability
Document Number: 2017-28139
Type: Notice
Date: 2017-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development.'' Timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development facilitate earlier availability of safe and effective drugs to the American public. This guidance describes FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity; describes the scope of appropriate interactions between FDA review teams and IND sponsors; outlines the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programs; describes the general expectations for the timing of FDA responses to IND sponsor inquiries; describes best practices and communication methods to facilitate interactions between FDA review teams and IND sponsors during drug development; and includes expectations on appropriate methods and frequency of such communications. This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND. This guidance finalizes the draft guidance issued on December 9, 2015.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-28107
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2017-28072
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is also welcome to listen to the meeting by dialing 888-946-7207, passcode: 5023213. A total of 200 lines will be available. To register for this call, please go to www.cdc.gov/hicpac.
Office for State, Tribal, Local and Territorial Support (OSTLTS), Tribal Advisory Committee (TAC) Meeting and 18th Biannual Tribal Consultation Session
Document Number: 2017-28071
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the following meeting and Tribal Consultation Session. The meetings are being hosted by CDC/ATSDR in-person only and are open to the public. Attendees must pre-register for the event by March 2, 2018, at the following link: www.cdc.gov/tribal/meetings.html.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
Document Number: 2017-28070
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the 75 telephone ports available. There will be a public comment period at the end of the meeting day from 3:30 p.m.-3:45 p.m., February 26, 2018.
Advisory Committee on Immunization Practices (ACIP); Notice of Charter Amendment
Document Number: 2017-28069
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to include a non- voting liaison representative; American Immunization Registry Association. The amended filing date is October 17, 2017.
Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
Document Number: 2017-28044
Type: Notice
Date: 2017-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program). The CfQ Pilot Program is voluntary and intends to evaluate product and manufacturing quality within the medical device ecosystem. The CfQ Pilot Program also intends to explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture. The pilot program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden on demonstrating quality assurance, and assure safety and effectiveness during product development and manufacturing.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery
Document Number: 2017-28042
Type: Rule
Date: 2017-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Council on Graduate Medical Education
Document Number: 2017-28015
Type: Notice
Date: 2017-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME) will hold a public meeting.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2017-27974
Type: Notice
Date: 2017-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Neurological Devices Panel of the Medical Devices 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.
New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator
Document Number: 2017-27973
Type: Rule
Date: 2017-12-28
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 amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
Document Number: 2017-27943
Type: Proposed Rule
Date: 2017-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the proposed rule that appeared in the November 28, 2017 issue of the Federal Register titled ``Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program''.
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-27936
Type: Notice
Date: 2017-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2017-28043
Type: Notice
Date: 2017-12-27
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 document entitled ``Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing pathogen reduction technology in the manufacture of pathogen-reduced blood components. The guidance also provides answers to frequently asked questions concerning the implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The recommendations apply to licensed blood establishments that intend to manufacture pathogen-reduced blood components using an FDA approved pathogen reduction device.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2017-27961
Type: Notice
Date: 2017-12-27
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 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: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
Document Number: 2017-27949
Type: Rule
Date: 2017-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.''
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-27939
Type: Notice
Date: 2017-12-27
Agency: Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-27938
Type: Notice
Date: 2017-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging Notice of Closed Meeting
Document Number: 2017-27937
Type: Notice
Date: 2017-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2017-27857
Type: Notice
Date: 2017-12-27
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization
Document Number: 2017-27856
Type: Rule
Date: 2017-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the rectal balloon for prostate immobilization's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms
Document Number: 2017-27855
Type: Rule
Date: 2017-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache
Document Number: 2017-27854
Type: Rule
Date: 2017-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems
Document Number: 2017-27853
Type: Rule
Date: 2017-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders
Document Number: 2017-27843
Type: Rule
Date: 2017-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for psychiatric disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
Document Number: 2017-27840
Type: Proposed Rule
Date: 2017-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 21, 2017, proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Patient Safety Organizations: Voluntary Relinquishment From the Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO)
Document Number: 2017-27803
Type: Notice
Date: 2017-12-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO) of its status as a PSO, and has delisted the PSO accordingly.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2017-27117
Type: Proposed Rule
Date: 2017-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (Sec. 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017
Document Number: 2017-27920
Type: Rule
Date: 2017-12-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017, including the applicable quality reporting period for the performance year. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. This interim final rule with comment period establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017, including the applicable quality data reporting period for the performance year.
Office of the Director; Notice of Charter Renewal
Document Number: 2017-27792
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-27791
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2017-27790
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
Document Number: 2017-27789
Type: Proposed Rule
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition, published in the Federal Register of September 21, 2017, revising food additive regulations to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-27787
Type: Notice
Date: 2017-12-26
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.
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability
Document Number: 2017-27786
Type: Notice
Date: 2017-12-26
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 ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
Document Number: 2017-27785
Type: Proposed Rule
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 22, 2017, proposing that the food additive regulations be amended to provide for the safe use of chromium DL-methionine as a nutritional source of chromium in cattle feed. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid
Document Number: 2017-27784
Type: Rule
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Final National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention (CRC)
Document Number: 2017-27762
Type: Notice
Date: 2017-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention (CRC).
Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
Document Number: 2017-27757
Type: Notice
Date: 2017-12-26
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 requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and Form FDA 2830.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA
Document Number: 2017-27745
Type: Notice
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYKADIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2017-27743
Type: Notice
Date: 2017-12-26
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 The National Survey of Family Growth (NSFG), designed to provide nationally representative, scientifically credible data on factors related to birth and pregnancy rates, family formation and dissolution patterns, and reproductive health.
Decision To Evaluate a Petition To Designate a Class of Employees From the Ames Laboratory in Ames, Iowa, To Be Included in the Special Exposure Cohort
Document Number: 2017-27724
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Ames Laboratory in Ames, Iowa, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.