Department: DEPARTMENT OF HEALTH AND HUMAN SERVICES
Years: 20002001200220032004200520062007200820092010201120122013[FR Doc 2011-33599] 1.Meetings:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : NATIONAL INSTITUTES OF HEALTH
[FR Doc 2011-33552] 2.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: Oncologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.
Date
Published: 2011-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : FOOD AND DRUG ADMINISTRATION
[FR Doc 2011-33549] 3.Determinations that Drugs Were Not Withdrawn from Sale for Reasons of Safety or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(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and 1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness.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 2011-33573] 4.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 2011-33550] 5.Draft Guidance for Industry; Availability:
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for OffLabel Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and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 2011-33588] 6.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 2011-33572] 7.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 2011-33555] 8.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 2011-33391] 9.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] 10.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 2011-33346] 11.System of Records
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'' (09901000). This system of records is being amended to include records regarding Federal and State benefit programs and service providers in
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : INSPECTOR GENERAL OFFICE
[FR Doc 2011-33494] 12.Meetings:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, National Advisory Neurological Disorders and Stroke.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : NATIONAL INSTITUTES OF HEALTH
[FR Doc 2011-33290] 13.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 2011-33303] 14.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 2011-33345] 15.Solicitation of New Safe Harbors and Special Fraud Alerts
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 antikickback statute (section 1128B(b)
[[Page 81905]]
of the Social Security Act), as well as
Published: 2011-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : INSPECTOR GENERAL OFFICE
[FR Doc 2011-33390] 16.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 2011-33382] 17.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 2011-33251] 18.Meetings:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : NATIONAL INSTITUTES OF HEALTH
[FR Doc 2011-33295] 19.Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH RESOURCES AND SERVICES ADMINISTRATION
[FR Doc 2011-33220] 20.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 2011-33321] 21.Comment Request
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH AND HUMAN SERVICES DEPARTMENT
[FR Doc 2011-33188] 22.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 2011-33294] 23.Meetings:
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92463), notice is hereby given of the following meeting:
Name: National Advisory Council on the National Health Service Corps (NHSC).
Dates and Times: January 19, 2012: 8:30 a.m.4:30 p.m. January 20, 2012: 8 a.m.12 p.m.
Place: Hilton Washington
Published: 2011-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : HEALTH RESOURCES AND SERVICES ADMINISTRATION
[FR Doc 2011-33183] 24.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 2011-33192] 25.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
Years: 20002001200220032004200520062007200820092010201120122013