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

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Submission for OMB Review; 30-Day Comment Request Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH; Correction
Document Number: 2019-26631
Type: Notice
Date: 2019-12-11
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on December 5, 2019. That Notice requires a correction in the Supplemental information section.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-26595
Type: Notice
Date: 2019-12-10
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-26594
Type: Notice
Date: 2019-12-10
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.
Supplemental Evidence and Data Request on Maternal and Fetal Effects of Mental Health Treatments in Pregnant and Breastfeeding Women: A Systematic Review of Pharmacological Interventions
Document Number: 2019-26510
Type: Notice
Date: 2019-12-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Maternal and Fetal Effects of Mental Health Treatments in Pregnant and Breastfeeding Women: A Systematic Review of Pharmacological Interventions, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2019-26507
Type: Notice
Date: 2019-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-26506
Type: Notice
Date: 2019-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-26505
Type: Notice
Date: 2019-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-26504
Type: Notice
Date: 2019-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-26503
Type: Notice
Date: 2019-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Request for Information on “Update on Selected Topics in Asthma Management 2020: A Report From the National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) Expert Panel Report 4 (EPR-4) Working Group”; Correction
Document Number: 2019-26502
Type: Notice
Date: 2019-12-10
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on December 2, 2019. That Notice requires a correction in the Dates section.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-26494
Type: Notice
Date: 2019-12-10
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Magnetic Resonance Coil-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-26470
Type: Notice
Date: 2019-12-09
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 ``Magnetic Resonance (MR) CoilPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.'' This draft guidance is not final nor is it in effect at this time.
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated With Internal or External Hemorrhoids; Draft Guidance for Industry; Availability
Document Number: 2019-26464
Type: Notice
Date: 2019-12-09
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 ``Development of Locally Applied Corticosteroid Products for the Short- Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.'' This draft guidance will serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Error Products, pharmaceutical sponsors, the academic community, and the public.
Notice to Announce the National Eye Institute (NEI) Draft Strategic Plan, 2020 Vision for the Future; Request for Information
Document Number: 2019-26451
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services, National Institutes of Health
This Request for Information (RFI) is intended to gather broad public input to assist the National Eye Institute (NEI), National Institutes of Health (NIH) in developing its next strategic plan titled, 2020 Vision for the Future. NEI invites input from vison researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.
Meeting of the Tick-Borne Disease Working Group
Document Number: 2019-26441
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the TBDWG will (1) hear presentations from eight subcommittees on findings and potential actions from reports prepared for the TBDWG to consider and (2) further discuss plans for developing the next report to the HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 report. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data Collection Tool for State Offices of Rural Health Grant Program, OMB No. 0915-0322-Revision
Document Number: 2019-26440
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.
Request for Information: Family Caregiving Advisory Council
Document Number: 2019-26438
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living and the Family Caregiving Advisory Council seek information to be used in the development of the Initial Report, the Family Caregiving Strategy and public listening sessions being planned for 2020.
Request for Information: Family Caregiving Advisory Council
Document Number: 2019-26437
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living and the Advisory Council to Support Grandparents Raising Grandchildren seek information to be used in the development of the Initial Report, as required by the Supporting Grandparents Raising Grandchildren Act.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-26385
Type: Notice
Date: 2019-12-06
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Division of Independent Review Application Reviewer Recruitment Form, OMB No. 0915-0295-Extension
Document Number: 2019-26384
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-26381
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-26377
Type: Notice
Date: 2019-12-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming joint public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-26374
Type: Notice
Date: 2019-12-06
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 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 a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Developmental Projects to Improve the National Health and Nutrition Examination Survey and Related Programs. This generic clearance request covers projects that will help evaluate and improve upon issues such as survey design and operations, as well as examine the feasibility and challenges that may arise with developing future content for the National Health and Nutrition Examination Survey (NHANES) (OMB# 0920-0950, expires November 30, 2021) or similar studies.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-26373
Type: Notice
Date: 2019-12-06
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 Assessment of Technical Assistance and Training (TTA) Approaches to Accelerate Comprehensive Cancer Control Outcomes. CDC is requesting to collect information about TTA offered using case studies and a web-based survey to assess whether a specific cooperative agreement has been implemented as intended, and has contributed to National Comprehensive Cancer Control Program (NCCCP) awardees' achievements in program goals and outcomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-26372
Type: Notice
Date: 2019-12-06
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 ``Asthma Information Reporting System (AIRS)'' (OMB Control No. 0920-0853; expiration date 5/31/2020). The purpose of AIRS is to collect performance measure and surveillance data designed to increase the efficiency and effectiveness of state, local and territorial asthma programs and to monitor the impact of state, local, territorial and national programs.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-26371
Type: Notice
Date: 2019-12-06
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 Requirements for the Importation of Nonhuman Primates into the United States. This information collection contains the reporting and documentation requirements for registered importers of nonhuman primates, as outlined in 42 Code of Federal Regulations part 71.53 Requirements for importers of nonhuman primates.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-26370
Type: Notice
Date: 2019-12-06
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 Coal Workers' Health Surveillance Program (CWHSP). The CWHSP is a congressionally-mandated medical examination program for monitoring the health of coal miners and was originally established under the Federal Coal Mine Health and Safety Act of 1969 with all subsequent amendments (the Act).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-26369
Type: Notice
Date: 2019-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-26368
Type: Notice
Date: 2019-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-26364
Type: Notice
Date: 2019-12-06
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-26362
Type: Notice
Date: 2019-12-06
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.
Availability of Draft Toxicological Profiles
Document Number: 2019-26361
Type: Notice
Date: 2019-12-06
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on Draft Toxicological Profiles for 1,2-Dichloropropane, 1,1-Dichloroethene, Di(2-ethylhexyl)phthalate (DEHP), DDT/DDE/DDD, Chlorobenzene, Hexachlorobutadiene, and 1,1,2- Trichloroethane.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-26338
Type: Notice
Date: 2019-12-06
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 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR); Meeting
Document Number: 2019-26329
Type: Notice
Date: 2019-12-06
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, Center for Preparedness and Response, (BSC, CPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 60 people. Public participants should pre-register for the meeting (see Supplementary Information for more information). The public is also welcome to listen to the meeting via Adobe Connect. Pre-registration is required by clicking the links below. WEB ID January 23, 2020 registration: https://adobeconnect.cdc.gov/ epvdyo95oxsu/event/registration.html. WEB ID January 24, 2020 registration: https://adobeconnect.cdc.gov/ ek6t1uq3f5zy/event/registration.html. Dial in number: 1-888-790-2046; Participant code: 5041683.
Determination of Regulatory Review Period for Purposes of Patent Extension; PALYNZIQ
Document Number: 2019-26327
Type: Notice
Date: 2019-12-06
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 PALYNZIQ 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 biological product.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-26324
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; State Plan Child Support Collection and Establishment of Paternity Title IV-D OCSE-100 and OCSE-21-U4
Document Number: 2019-26323
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the forms OCSE- 21-U4: Transmittal and Notice of Approval of State Plan Material for: Title IV-D of the Social Security Act and OCSE-100: State Plan (OMB #0970-0017, expiration 7/31/2020).
National Institute on Aging; Notice of Meeting
Document Number: 2019-26316
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2019-26315
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2019-26314
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2019-26313
Type: Notice
Date: 2019-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH
Document Number: 2019-26294
Type: Notice
Date: 2019-12-05
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.
Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee
Document Number: 2019-26279
Type: Notice
Date: 2019-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-26278
Type: Notice
Date: 2019-12-05
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.
Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
Document Number: 2019-26276
Type: Notice
Date: 2019-12-05
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 nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. 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 and upcoming vacancies effective with this notice.
Novel Excipient Review Program Proposal; Request for Information and Comments
Document Number: 2019-26266
Type: Notice
Date: 2019-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in determining whether it should establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. The Agency hopes to obtain information and comments on several aspects of such a program before deciding whether to develop it.
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2019-26264
Type: Notice
Date: 2019-12-05
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 ``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.'' There is pharmaceutical and stakeholder interest in the development of new drugs for patients with IC/BPS. This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat IC/BPS.
Submission for OMB Review; 30-Day Comment Request Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH
Document Number: 2019-26260
Type: Notice
Date: 2019-12-05
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUXTURNA
Document Number: 2019-26252
Type: Notice
Date: 2019-12-05
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 LUXTURNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEXXA
Document Number: 2019-26251
Type: Notice
Date: 2019-12-05
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 ANDEXXA 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 patents which claims that human biological product.