Department of Health and Human Services November 1, 2016 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Comment Request
Document Number: 2016-26336
Type: Notice
Date: 2016-11-01
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Document Number: 2016-26322
Type: Notice
Date: 2016-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-26321
Type: Notice
Date: 2016-11-01
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 renewal of the approved information collection assigned OMB control number 0990-0323, scheduled to expire on January 31, 2017. 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.
Medical Device User Fee Amendments; Public Meeting; Request for Comments; Extension of Comment Period
Document Number: 2016-26318
Type: Notice
Date: 2016-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the Medical Device User Fee Amendments (MDUFA) reauthorization draft recommendations that were announced in the Federal Register on October 7, 2016. In that Federal Register notice, FDA requested comments on the draft recommendations related to the reauthorization of the medical device user fee amendments. The Agency is taking this action to allow interested persons the statutorily required 30 days to submit comments.
What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide; Availability
Document Number: 2016-26315
Type: Rule
Date: 2016-11-01
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 guidance for industry entitled ``What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food''Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.''
What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide; Availability
Document Number: 2016-26314
Type: Rule
Date: 2016-11-01
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 guidance for industry #241 entitled ``What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals''Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.''
Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper
Document Number: 2016-26310
Type: Rule
Date: 2016-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses. This action is in response to a petition filed by Milton W. Chu, M.D.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Maternal, Infant, and Early Childhood Home Visiting Program Fiscal Year (FY) 2015, FY 2016, FY 2017 Non-Competing Continuation Progress Report for Formula Grant
Document Number: 2016-26284
Type: Notice
Date: 2016-11-01
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 (Section 3506(c)(2)(A) 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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Nurse Anesthetist Traineeship Program Specific Data Forms
Document Number: 2016-26283
Type: Notice
Date: 2016-11-01
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 (Section 3506(c)(2)(A) 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.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-26261
Type: Notice
Date: 2016-11-01
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Invention; Availability for Licensing
Document Number: 2016-26260
Type: Notice
Date: 2016-11-01
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 in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Cancer Institute; Amended Notice of Meeting
Document Number: 2016-26259
Type: Notice
Date: 2016-11-01
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards
Document Number: 2016-26258
Type: Notice
Date: 2016-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 recordkeeping requirements for institutional review boards (IRBs).