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At least 19 recordsLinked to original sources
PubMed1998

Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop.

The Food and Drug Administration (FDA) is announcing a public workshop to present issues related to the agency's proposed rule entitled "Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License" issued recently in the Federal Register. The purpose of the public workshop is to provide interested persons an opportunity to more clearly understand the proposed rule and its effect on industry and the public.

Biological Products↗
PubMed1998

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Consumer Product Safety↗
PubMed1982

List of primary care and dental health manpower shortage areas designated under section 332 of the Public Health Service Act.

This notice provides a list, updated as of March 31, 1982, of primary care and dental health manpower shortage areas designated by the Secretary of Health and Human Services under the authority of section 332 of the Public Health Service Act. (At a later date, an update of the lists of psychiatric, vision care, podiatric, pharmacy, and veterinary health manpower shortage areas will be published).

Dentistry↗
PubMed1998

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction.

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.

Consumer Product Safety↗
PubMed1983

Discontinuation of approval of modifications in notes, guaranteed under Title VI or VII of the Public Health Service Act, proposed to permit use of the notes as collateral for tax-exempt financings--PHS. Final rule.

The Department of Health and Human Services (HHS) adds a new section to regulations for making and guaranteeing loans for construction and modernization of hospitals and medical facilities and to regulations for guaranteeing loans for the construction of teaching facilities for health professions personnel. Under these regulations HHS will not approve the modification of the terms of an existing loan guaranteed under Title VI or Title VII of the Public Health Service (PHS) Act if the modification would permit use of the guarantee (or guaranteed loan) as collateral for tax-exempt financing.

Financial Management↗