Department of Health and Human Services April 24, 2017 – Federal Register Recent Federal Regulation Documents

Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2017-08220
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given of the following meeting for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). The meeting will be open to the public but advance registration is required. The online registration deadline is Thursday, May 4, 2017, 5:00 p.m. Eastern Time. Please check the Web site for additional guidance and registration information. The registration link is https://www.achdncmeetings.org/. Information about the agenda for this meeting can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2017-08200
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0990-0452, scheduled to expire on January 31, 2020. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability
Document Number: 2017-08199
Type: Notice
Date: 2017-04-24
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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on Naloxone Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-Extension
Document Number: 2017-08197
Type: Notice
Date: 2017-04-24
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.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2017-08189
Type: Notice
Date: 2017-04-24
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 Gastroenterology and Urology 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.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2017-08188
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Delta States Rural Development Network Grant Program, OMB No. 0915-0386-Revision
Document Number: 2017-08187
Type: Notice
Date: 2017-04-24
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.
Training Program for Regulatory Project Managers; Information Available to Industry
Document Number: 2017-08183
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting
Document Number: 2017-08182
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a 1-day public symposium entitled ``Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.'' The purpose of this symposium is to discuss sources of preventable harm from drugs in the outpatient setting and to stimulate the exchange of ideas among thought leaders on interventions to reduce preventable harms and how these interventions can be studied.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information From United States Firms and Processors That Export to the European Union
Document Number: 2017-08181
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Guerbet Group; Withdrawal of Approval of Two New Drug Applications
Document Number: 2017-08179
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Guerbet Group. Guerbet Group notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop
Document Number: 2017-08178
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), Professional Affairs and Stakeholder Engagement Staff (PASES), is announcing a 1-day public workshop entitled ``Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population.'' The purpose of this workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes; to reduce the risk of serious hypoglycemia; identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease; discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients; and disseminate the results of this discussion to inform patients, patient advocates, and health care practitioners.
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
Document Number: 2017-08177
Type: Notice
Date: 2017-04-24
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 Science Board to the FDA. The general function of the committee is to provide advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. This meeting is open to the public.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2017-08176
Type: Notice
Date: 2017-04-24
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 Vaccines and Related Biological Products Advisory Committee (VRBPAC). 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.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-08175
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2017-08167
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Administration for Children and Families
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2017-08140
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-08139
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-08138
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2017-08137
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, National Institutes of Health
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