The Federal Register

Studies To Determine the Prevalence of a History of Traumatic Brain Injury (TBI) in an Institutionalized Population

Wed, Dec 10 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: 04062.

Catalog of Federal Domestic Assistance Number: 93.136.

Key Dates:

Letter of Intent Deadline: January 9, 2004.

Application Deadline: February 18, 2003.

I. Funding Opportunity Description

Authority: This program is authorized under sections 391(a) and 301(a) of the Public Health Service Act (PHS Act) and 42 U.S.C. 241(a) and 280b(a) as amended.

Purpose: The purpose of the program is to fund a cooperative agreement to conduct pilot studies to investigate methods for determining the prevalence of a history of traumatic brain injury (TBI) in an institutionalized population. For purposes of this RFA, ``institutionalized'' refers to persons who are either incarcerated or residing in a nursing home. Research on only one of these populations should be proposed.

Anecdotal reports suggest that a very large proportion of the prison population may have experienced one or more TBIs, with many of them occurring prior to

Radiation and Worker Health Advisory Board Meeting; Correction

Wed, Dec 10 2003 11:00:00 GMT

Correction: In the Federal Register of November 17, 2003, in DOCID: fr17no03102, Volume 68, Number 221, Page 64902, concerning the purpose for closing a portion of the meeting of the Advisory Board on Radiation and Worker Health, the notice cited an incorrect reason for the meeting closure. Correct ``Matters to be Discussed'' to read:

The closed portion of the meeting on the afternoon of December 10th will involve a review and discussion of the Independent Government Cost Estimate (IGCE) for task order contracts and proposals of work for the performance of these task order contracts, which could lead to a revision of the IGCE. These contracts will serve to provide technical support consultation to assist the ABRWH in fulfilling its statutory duty to advise the Secretary of Health and Human Services on the scientific validity and quality of dose estimation and reconstruction efforts under the Energy Employees Occupational Illness Compensation Program Act. These discussions will include re

Injectable or Implantable Dosage Form New Animal Drugs; Meloxicam

Wed, Dec 10 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for use of meloxicam injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis.

Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder

Wed, Dec 10 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder in honeybees for the control and treatment of foulbrood, and in swine drinking water with a reduction in preslaughter withdrawal time to zero days.

Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components;

Wed, Dec 10 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components'' dated December 2003. The guidance document recognizes the ``Circular of Information for the Use of Human Blood and Blood Components'' (the circular) dated July 2002 as acceptable for use by manufacturers of blood and blood components intended for transfusion. The circular will assist manufacturers in complying with the labeling requirements under FDA regulations. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2002.

Agency Information Collection Activities: Proposed Collection; Comment Request

Wed, Dec 10 2003 11:00:00 GMT

Program Exclusions: November 2003

Wed, Dec 10 2003 11:00:00 GMT

During the month of November 2003, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusion is imposed, no program payment is made to anyone for any items or services (other than an emergency item or service not provided in a hospital emergency room) furnished, ordered or prescribed by an excluded party under the Medicare, Medicaid, and all Federal Health Care programs. In addition, no program payment is made to any business or facility, e.g., a hospital, that submits bills for payment for items or services provided by an excluded party. Program beneficiaries remain free to decide for themselves whether they will continue to use the services of an excluded party even though no program payments will be made for items and services provided by that excluded party. The exclusions have national effect and also apply to all Executive Branch procurement and nonprocurement programs and activities.
Office of Investigation, Office of Inspector Gene

Agency Information Collection Activities: Proposed Collection; Comment Request

Wed, Dec 10 2003 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (301) 4437978.

Comments are invited on:
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(a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents, including through the use of automate