Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Trackerhttps://regulations.justia.com/regulations/fedreg/agencies/department-of-health-and-human-services/2011?limit=200®isters=between&min-day=1&min-month=1&max-day=31&max-month=12&mode=atom2024-05-23T19:03:14-07:00Justia Inchttps://www.justia.com/Justia Regulations Trackerhttps://regulations.justia.com/images/justiafedregulations.gifCopyright 2011 Justia Inchttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33599.htmlNotice - National Institute of Mental Health; Notice of Closed Meetings2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33599Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33599.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33597.htmlNotice - National Institute on Aging; Notice of Closed Meeting2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33597Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33597.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33588.htmlRule - Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33588Rulehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33588.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33576.htmlNotice - Request for Nominations of Candidates To Serve on the Advisory Committee on Breast Cancer in Young Women (ACBCYW)2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33576Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33576.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33574.htmlNotice - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Data Coordinating Center for Autism and Other Developmental Disabilities Research and Epidemiologic Studies, RFA DD12-001, Initial Review2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33574Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33574.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33573.htmlNotice - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33573Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33573.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33572.htmlNotice - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33572Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33572.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33561.htmlNotice - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33561Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33561.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33555.htmlNotice - Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33555Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33555.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33553.htmlNotice - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33553Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33553.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33552.htmlNotice - Oncologic Drugs Advisory Committee; Notice of Meeting2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33552Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33552.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33551.htmlNotice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33551Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33551.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33550.htmlNotice - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33550Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33550.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33549.htmlNotice - 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 Effectiveness2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33549Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33549.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33548.htmlNotice - Oncologic Drugs Advisory Committee; Notice of Meeting2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33548Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33548.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/30/2011-33388.htmlNotice - Clinical Laboratory Improvement Advisory Committee (CLIAC)2011-12-30T00:00:00-08:002011-12-30T00:00:00-08:002011-33388Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33388.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33497.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33497Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33497.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33496.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33496Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33496.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33494.htmlNotice - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33494Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33494.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33492.htmlNotice - Center for Scientific Review; Notice of Closed Meetings2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33492Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33492.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33491.htmlNotice - National Institute on Drug Abuse; Notice of Closed Meeting2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33491Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33491.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33489.htmlNotice - National Institute on Drug Abuse; Notice of Meeting2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33489Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33489.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33484.htmlNotice - National Cancer Institute; Notice of Closed Meetings2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33484Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33484.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33483.htmlNotice - Center for Scientific Review; Notice of Closed Meeting2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33483Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33483.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33481.htmlNotice - Center for Scientific Review; Notice of Closed Meetings2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33481Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33481.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33479.htmlNotice - National Institute on Drug Abuse; Notice of Closed Meeting2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33479Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33479.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33396.htmlNotice - World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC or Advisory Committee), National Institute for Occupational Safety and Health (NIOSH)2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33396Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33396.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33391.htmlNotice - Agency Information Collection Request. 30-Day Public Comment Request2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33391Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33391.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33390.htmlNotice - Agency Information Collection Request 30-Day Public Comment Request2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33390Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33390.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33382.htmlRule - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33382Rulehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33382.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33346.htmlNotice - Privacy Act; System of Records2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33346Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33346.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33345.htmlProposed Rule - Solicitation of New Safe Harbors and Special Fraud Alerts2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33345Proposed Rulehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33345.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33303.htmlNotice - 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 Sugars2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33303Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33303.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33293.htmlNotice - Agency Information Collection Activities: Proposed Collection; Comment Request2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33293Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33293.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/29/2011-33290.htmlNotice - Request for Measures and Domains To Use in Development of a Standardized Instrument for Use in Public Reporting of Family Experience of Pediatric Inpatient Care2011-12-29T00:00:00-08:002011-12-29T00:00:00-08:002011-33290Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33290.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33321.htmlNotice - Agency Information Collection Activities: Submission for OMB Review; Comment Request2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33321Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33321.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33295.htmlNotice - Agency Information Collection Activities: Proposed Collection: Comment Request2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33295Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33295.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33294.htmlNotice - National Advisory Council on the National Health Service Corps; Notice of Meeting2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33294Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33294.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33292.htmlNotice - Guidance for Industry: Prevention of Salmonella2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33292Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33292.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33265.htmlNotice - Administration on Children, Youth and Families; Statement of Organization, Functions, and Delegations of Authority2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33265Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33265.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33251.htmlNotice - Center for Scientific Review; Notice of Closed Meeting2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33251Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33251.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33232.htmlNotice - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Availability2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33232Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33232.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33230.htmlNotice - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33230Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33230.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33220.htmlNotice - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33220Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33220.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33192.htmlNotice - Submission for OMB Review; Comment Request2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33192Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33192.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33188.htmlNotice - Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33188Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33188.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/28/2011-33183.htmlRule - Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction2011-12-28T00:00:00-08:002011-12-28T00:00:00-08:002011-33183Rulehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33183.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/27/2011-33142.htmlNotice - 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 Period2011-12-27T00:00:00-08:002011-12-27T00:00:00-08:002011-33142Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-27/pdf/2011-33142.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/27/2011-33141.htmlNotice - 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 Period2011-12-27T00:00:00-08:002011-12-27T00:00:00-08:002011-33141Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-27/pdf/2011-33141.pdfhttps://regulations.justia.com/regulations/fedreg/2011/12/27/2011-33140.htmlNotice - 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 Application2011-12-27T00:00:00-08:002011-12-27T00:00:00-08:002011-33140Noticehttp://www.gpo.gov/fdsys/pkg/FR-2011-12-27/pdf/2011-33140.pdf