Department of Health and Human Services August 24, 2016 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-20259
Type: Notice
Date: 2016-08-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-20239
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; Availability
Document Number: 2016-20221
Type: Notice
Date: 2016-08-24
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 ``Patient Preference InformationVoluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI), which may inform FDA's benefit-risk determinations in the premarket review of premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, and de novo classification requests. This guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,'' originally issued on March 28, 2012, that has been edited to be consistent with this guidance document.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-20216
Type: Notice
Date: 2016-08-24
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.
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
Document Number: 2016-20198
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of the following meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT).
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-20188
Type: Notice
Date: 2016-08-24
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.
Health Insurance MarketplaceSM
Document Number: 2016-20187
Type: Notice
Date: 2016-08-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\ and the Medicare, Medicaid, and Children's Health Insurance Programs consumer education strategies. This meeting is open to the public.
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
Document Number: 2016-20177
Type: Proposed Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.''
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Document Number: 2016-20176
Type: Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-20162
Type: Notice
Date: 2016-08-24
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 and/or co-development 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 and/or co-development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-20160
Type: Notice
Date: 2016-08-24
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 and/or co-development 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 and/or co-development.
Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of Report
Document Number: 2016-20159
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2014-2015. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), describes activities and accomplishments from January 2014 through December 2015.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-20158
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extension of the approved information collection assigned OMB control number OS-0990-0323, which expires on January 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2016-20151
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-20150
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feed; Category Definitions
Document Number: 2016-20149
Type: Proposed Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
New Animal Drugs for Use in Animal Feed; Category Definitions
Document Number: 2016-20148
Type: Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability
Document Number: 2016-20146
Type: Notice
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled ``Draft Guidance on Fidaxomicin.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fidaxomicin tablets.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-20129
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Disqualification of a Clinical Investigator
Document Number: 2016-19876
Type: Proposed Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend 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. Currently, 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 is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when 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 proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Good Laboratory Practice for Nonclinical Laboratory Studies
Document Number: 2016-19875
Type: Proposed Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System. We also propose to revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity.