Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents

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National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2011-33599
Type: Notice
Date: 2011-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2011-33597
Type: Notice
Date: 2011-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
Document Number: 2011-33588
Type: Rule
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.
Request for Nominations of Candidates To Serve on the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2011-33576
Type: Notice
Date: 2011-12-30
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability
Document Number: 2011-33573
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
As part of the Transparency Initiative, the Food and Drug Administration (FDA or Agency) is announcing the availability of a report entitled ``Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.'' This report was prepared in response to Action Item 11 in the Phase III Report (FDA Transparency Initiative: Improving Transparency to Regulated Industry, dated January 2011). In that action item, the Commissioner of Food and Drugs (the Commissioner), Dr. Margaret A. Hamburg, called for a cross- Agency working group to prepare a report identifying FDA's ``best practices'' and making recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and make it easier to find guidance documents on FDA's Web site.
Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
Document Number: 2011-33572
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011. The guidance document provides recommendations to establishments for complying with CGTP and additional requirements for manufacturers of HCT/Ps. The guidance is intended for any HCT/P establishment that performs a manufacturing step and is responsible for complying with CGTP requirements. The guidance also addresses whether the establishment registration and HCT/P listing requirements apply in certain instances. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2009.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33561
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
Document Number: 2011-33555
Type: Notice
Date: 2011-12-30
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on certain labeling requirements for blood and blood components, including Source Plasma. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a system for labeling blood and blood components, and the use of new labeling systems that may be developed in the future. Additionally, these requirements are issued to help ensure the continued safety of the blood supply and facilitate consistency in labeling.
Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability
Document Number: 2011-33553
Type: Notice
Date: 2011-12-30
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 ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance discusses the processes that should be considered to ensure the quality and integrity of histology data in biomarker studies, and outlines the scientific standards for histology used in biomarker characterization and qualification. The recommendations in this guidance are intended for studies in biomarker qualification designated to justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histologic changes is essential. The principles outlined in this guidance are also applicable to exploratory biomarker studies.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33552
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
Document Number: 2011-33551
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability
Document Number: 2011-33550
Type: Notice
Date: 2011-12-30
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 ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
Determination That HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-33549
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, 5 milligrams (mg)/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and 1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrocodone bitartrate and homatropine methylbromide tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, if all other legal and regulatory requirements are met.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33548
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2011-33388
Type: Notice
Date: 2011-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2011-33497
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-33496
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-33494
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-33492
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2011-33491
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2011-33489
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2011-33484
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-33483
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-33481
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2011-33479
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2011-33391
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services
Agency Information Collection Request 30-Day Public Comment Request
Document Number: 2011-33390
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
Document Number: 2011-33382
Type: Rule
Date: 2011-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.
Privacy Act; System of Records
Document Number: 2011-33346
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with the Privacy Act of 1974, as amended, the Office of Inspector General gives notice of a proposed amendment to its Privacy Act system of records entitled ``Consolidated Data Repository'' (09-90-1000). This system of records is being amended to include records regarding Federal and State benefit programs and service providers in Federal health care programs.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2011-33345
Type: Proposed Rule
Date: 2011-12-29
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars
Document Number: 2011-33303
Type: Notice
Date: 2011-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-33293
Type: Notice
Date: 2011-12-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``MEPS Cancer Self Administrated Questionnaire.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 2nd, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Request for Measures and Domains To Use in Development of a Standardized Instrument for Use in Public Reporting of Family Experience of Pediatric Inpatient Care
Document Number: 2011-33290
Type: Notice
Date: 2011-12-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or domains (for example, key concepts) measuring aspects of families' experience with the quality of inpatient medical and surgical hospital care from all researchers, vendors, hospitals, stakeholders, and other interested parties. The survey development team of Children's Hospital Boston Center of Excellence for Pediatric Quality Measurement (CEPQM), is one of the CHIPRA Pediatric Quality Measures Program (PQMP) Centers of Excellence, which were created pursuant to an interagency agreement between the Centers for Medicare & Medicaid Services (CMS) and AHRQ, and are funded through cooperative agreement awards with AHRQ. AHRQ is interested in instruments and items through which families of pediatric patients assess the care their child receives during the child's inpatient stay. The goal is to develop a standardized instrument for use in the public reporting of family experience of pediatric inpatient care. The team developing this survey intends to submit it to the CAHPS Consortium to request use of the CAHPS trademark. The survey will be developed in accordance with CAHPS Survey Design Principles and will develop implementation instructions based on those for CAHPS instruments (https://www.cahps.AHRQ.gov/About-CAHPS/Principles.aspx.) All CAHPS surveys are available to users free of charge and are published on the AHRQ Web site.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-33321
Type: Notice
Date: 2011-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-33295
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: 2011-33294
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Guidance for Industry: Prevention of Salmonella
Document Number: 2011-33292
Type: Notice
Date: 2011-12-28
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 ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The document provides guidance to egg producers on how to comply with certain provisions contained in FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the final rule), including how to implement Salmonella Enteritidis (SE) prevention measures, how to sample for SE., and how to maintain records documenting compliance with the final rule.
Administration on Children, Youth and Families; Statement of Organization, Functions, and Delegations of Authority
Document Number: 2011-33265
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families (ACF) has reorganized the Administration on Children, Youth and Families (ACYF). This reorganization realigns the Children's Bureau Data and Technology Team and the Family and Youth Services Bureau Research, Data, and Evaluation Team to create the Office of Data Analysis, Research, and Evaluation. It also renames the Division of Research and Innovation to the Division of Program Innovation. It renames the Division of Youth Services to the Division of Adolescent Development and Support. It deletes the Division of Abstinence Programs. Additionally, it deletes the Mentoring Children of Prisoners program.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-33251
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Availability
Document Number: 2011-33232
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' FDA developed this draft guidance document to provide a contemporary perspective on how FDA reviews premarket notification (510(k)) submissions as well as on the Special and Abbreviated 510(k) programs. This guidance addresses the major aspects of the 510(k) decision-making process and updates FDA's policies with respect to the Special and Abbreviated 510(k) programs. This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability
Document Number: 2011-33230
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH employees. The document also provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this time.
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2011-33220
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2011-33192
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments
Document Number: 2011-33188
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange. FDA is interested in obtaining comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (``off-label'' use) and use of products not yet legally marketed for any use.
Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction
Document Number: 2011-33183
Type: Rule
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Thursday, March 3, 2011 (76 FR 11892). The final rule amended FDA's regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass thermometers, during processing. The final rule was published with one error. This document corrects that error.
Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Extension of Comment Period
Document Number: 2011-33142
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is taking this action to allow interested persons additional time to submit comments.
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period
Document Number: 2011-33141
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Document Number: 2011-33140
Type: Notice
Date: 2011-12-27
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 FDA guidance for industry on ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This guidance document provides recommendations on postmarketing serious adverse event reporting for nonprescription (over-the-counter) human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports.