Department of Health and Human Services February 25, 2013 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Comment Request
Document Number: 2013-04278
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-04270
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2013-04256
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Office of Health Assessment and Translation Approach for Systematic Review and Evidence Integration for Literature-Based Health Assessments-February 2013; Request for Comments; Notice of a Meeting
Document Number: 2013-04254
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) requests public comments on the Draft Office of Health Assessment and Translation (OHAT) Approach for Systematic Review and Evidence Integration for Literature- Based Health AssessmentsFebruary 2013 (available at http:// ntp.niehs.nih.gov/go/38138). The NTP also plans to release two protocols to illustrate the application of this framework. These documents were prepared by the OHAT, Division of NTP, National Institute of Environmental Health Sciences (NIEHS). The NTP will hold a public web-based, informational meeting during the public-comment period to provide an overview of the framework, describe the contents in the case-study protocols, and respond to questions from the public on any of the documents.
Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance
Document Number: 2013-04251
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, that was announced in the Federal Register on May 2, 2006. The guidance explained FDA's then current thinking on the labeling of certain uses of lecithin derived from soy under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and was part of FDA's implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA). We are taking this action because the policy stated in the guidance regarding FDA's consideration of the exercise of enforcement discretion no longer reflects our current thinking.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-04233
Type: Notice
Date: 2013-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Fecal Microbiota for Transplantation; Public Workshop
Document Number: 2013-04232
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-04215
Type: Notice
Date: 2013-02-25
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: 2013-04213
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-04212
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-04211
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-04210
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-04209
Type: Notice
Date: 2013-02-25
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: 2013-04208
Type: Notice
Date: 2013-02-25
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: 2013-04207
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-04206
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-04205
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-04204
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-04203
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
Document Number: 2013-04201
Type: Proposed Rule
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus Resistance Data; Availability
Document Number: 2013-04196
Type: Notice
Date: 2013-02-25
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 entitled ``Attachment to Guidance on Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.'' The purpose of this attachment is to assist sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. HCV resistance data submitted in appropriately formatted datasets is a critical component in the review of investigational antiviral products for the treatment of HCV. The information in this attachment will facilitate the development and regulatory review of anti-HCV products.
Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements; Availability
Document Number: 2013-04195
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological ProductsImplementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.
Notice of Meeting
Document Number: 2013-04181
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2013-04176
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-04152
Type: Notice
Date: 2013-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting.
Document Number: 2013-04141
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
Control of Communicable Diseases: Interstate; Scope and Definitions
Document Number: 2013-04139
Type: Proposed Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that solicited public comment on updates to the Scope and Definitions for its regulations.
Control of Communicable Diseases: Interstate; Scope and Definitions
Document Number: 2013-04137
Type: Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on December 26, 2012 (77 FR 75880).
Control of Communicable Diseases: Foreign; Scope and Definitions
Document Number: 2013-04136
Type: Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on December 26, 2012 (77 FR 75939).
Control of Communicable Diseases: Foreign; Scope and Definitions
Document Number: 2013-04131
Type: Proposed Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that solicited public comment on updates to the Scope and Definitions for its regulations.
Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation
Document Number: 2013-04084
Type: Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
This final rule sets forth standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this final rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This rule also finalizes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and amends regulations providing an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.