Agency: Health and Human Services Department
Years: 20002001200220032004200520062007200820092010201120122013[FR Doc 2011-33572] 1.Guidance for Industry; Availability:
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 TissueBased Products (HCT/Ps)'' dated December 2011. The guidance document provides recommendations to
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33573] 2.Report on Good Guidance Practices; Availability:
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
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33588] 3.Medical Devices:
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
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33555] 4.Agency Information Collection Activities; Proposals, Submissions, and
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
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33549] 5.Determinations that Drugs Were Not Withdrawn from Sale for Reasons of Safety or
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.
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33550] 6.Draft Guidance for Industry; Availability:
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for OffLabel 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
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33390] 7.Day Public Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33391] 8.Day Public Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33293] 9.Comment Request
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. 35013521, AHRQ invites the public to
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33303] 10.Agency Information Collection Activities; Proposals, Submissions, and
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.
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33290] 11.Measure and Domains for Development; Solicitation:
Section 401(a) of the Children's Health Insurance Program
Reauthorization Act of 2009 (CHIPRA), Public Law 1113, amended the
Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b 9a). Section 1139A(b) charged the Department of
[[Page 81946]]
Health and Human Services with improving pediatric health care quality
measures. The Agency
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33382] 12.Ophthalmic and Topical Dosage Form New Animal Drugs:
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
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33192] 13.Comment Request
Title: University Centers for Excellence in Developmental Disabilities Education, Research, and ServiceAnnual Report.
OMB No.: 09700289.
Description
Section 104 (42 U.S.C. 15004) of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000) directs the Secretary of Health and Human Services to develop and
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33188] 14.Communications and Activities:
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 offlabel 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
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33232] 15.Draft Guidances for Industry and Staff; Availability:
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
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33292] 16.Guidance for Industry:
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
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33220] 17.Meetings:
This notice announces a forthcoming teleconference meeting of a
public advisory committee of the Food and Drug Administration (FDA). At least one
[[Page 81514]]
portion of the meeting will be closed to the public.
Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee.
General Function of the Committee: To provide
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33265] 18.Statement of Organization, Functions, and Delegations of Authority:
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
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33183] 19.Temperature-Indicating Devices:
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 lowacid foods packaged in hermetically sealed containers to allow for use of other temperatureindicating devices, in addition to
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33321] 20.Comment Request
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33140] 21.Agency Information Collection Activities; Proposals, Submissions, and
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
Published: 2011-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33141] 22.Draft Guidance for Industry, Clinical Investigators, Institutional Review
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
Published: 2011-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33142] 23.Draft Guidance for Industry and Staff; Availability:
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
Published: 2011-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33059] 24.Meetings:
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee.
[[Page 80949]]
General Function of the Committee: To provide advice and recommendations to the Agency on
Published: 2011-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33060] 25.Requests for Nominations:
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, and the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations
Published: 2011-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
Years: 20002001200220032004200520062007200820092010201120122013