Department of Health and Human Services March 7, 2016 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-05073
Type: Notice
Date: 2016-03-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-04984
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation; Public Workshop; Request for Comments
Document Number: 2016-04965
Type: Notice
Date: 2016-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled ``Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.'' The purposes of the workshop are to share current FDA experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities; discuss current and future utility of mechanism-based absorption modeling and simulation in the development of bioequivalent oral drug products and regulatory reviews; obtain input from various stakeholders on when, where, and how to conduct mechanism-based absorption modeling and simulations in the context of bioequivalent product development; and request comments on these topics.
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity; Guidance for Industry; Availability
Document Number: 2016-04964
Type: Notice
Date: 2016-03-07
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 ``Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity.'' It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA.
A Dietary Supplement Labeling Guide: Chapter II. Identity Statement; Guidance for Industry; Availability
Document Number: 2016-04948
Type: Notice
Date: 2016-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.'' This guidance is part of a longer guidance entitled ``A Dietary Supplement Labeling Guide,'' which covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We are revising the guidance to correct an inaccurate statement.
Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-04947
Type: Notice
Date: 2016-03-07
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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this draft guidance to assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. This draft guidance is not final nor is it in effect at this time.
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-04946
Type: Notice
Date: 2016-03-07
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 ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection).
New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations
Document Number: 2016-04945
Type: Rule
Date: 2016-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is removing regulations that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations.
Canned Tuna Deviating From Identity Standard: Temporary Permit for Market Testing
Document Number: 2016-04944
Type: Notice
Date: 2016-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the extension of temporary permits issued to Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants) to market test products (designated as ``canned tuna'') that deviate from the U.S. standard of identity for canned tuna. The extension allows the applicants to continue to measure consumer acceptance of the products and assess the commercial feasibility of the products, in support of a petition to amend the standard of identity for canned tuna. We also invite other interested parties to participate in the market test.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Document Number: 2016-04940
Type: Rule
Date: 2016-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. This action is being taken to reflect the change made to the charter for this advisory committee.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-04939
Type: Notice
Date: 2016-03-07
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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``DELTA FOCUS Program Evaluation.'' CDC will use the information collected to improve the national DELTA FOCUS program, and to develop strategy interactions to help the DELTA FOCUS program meet the requirements of the Funding Opportunity Announcement.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-04938
Type: Notice
Date: 2016-03-07
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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on An Assessment of the State Public Health Actions (``1305'') Program, a study to explore state-level partnerships and synergy among state health departments funded through the State Public Health Actions 1305 cooperative agreement.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-04933
Type: Notice
Date: 2016-03-07
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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection request Qualitative Information Collection on Emerging Diseases among the Foreign-born in the US that enables CDC improve the planning and implementation of disease prevention and control strategies targeting communicable diseases and other emerging health issues among high-risk foreign-born communities in specific and limited geographic areas in the United States where high numbers of those populations live.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2016-04927
Type: Notice
Date: 2016-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Senior Medicare Patrol (SMP) Program Outcome Measurement
Document Number: 2016-04925
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evidence-Based Falls Prevention Program Standardized Data Collection
Document Number: 2016-04924
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services
The Administration for Community Living (ACL), Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information. 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 information collection requirements relating to the Chronic Disease Self-Management Education Program.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-04922
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-04921
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 2016-04920
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 2016-04919
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2016-04918
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2016-04917
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2016-04916
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-04915
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-04914
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Workshop on Shift Work at Night, Artificial Light at Night, and Circadian Disruption; Notice of Public Meeting; Registration Information; Amended Notice
Document Number: 2016-04902
Type: Notice
Date: 2016-03-07
Agency: Department of Health and Human Services, National Institutes of Health
This notice amends Federal Register notice 81 FR 7354 published February 11, 2016, announcing the public meeting and registration information for the Workshop on Shift Work at Night, Artificial Light at Night, and Circadian Disruption. Registration is available to attend the workshop in-person both March 10 and March 11 and will close prior to March 4 if space capacity at NIEHS is reached. Registration to view the webcast is requested, but not required. All other information in the original notice has not changed. Information on the workshop and registration is available at http:// ntp.niehs.nih.gov/go/workshop_ALAN.
Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
Document Number: 2016-04893
Type: Notice
Date: 2016-03-07
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 document entitled ``Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for screening donors for evidence of, and risk factors for, infection with Zika virus (ZIKV). The guidance identifies ZIKV as a relevant communicable disease agent or disease (RCDAD) and adds to recommendations contained in the guidance entitled ``Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007.