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Sunday, May 3, 2020 | History

3 edition of Biological products: Public Health Service regulations, title 42, part 73. found in the catalog.

Biological products: Public Health Service regulations, title 42, part 73.

United States. Public Health Service.

Biological products: Public Health Service regulations, title 42, part 73.

by United States. Public Health Service.

  • 112 Want to read
  • 36 Currently reading

Published by Available from the Division of Biologics Standards, National Institutes of Health, Bethesda, Md. in Washington .
Written in English

    Places:
  • United States.
    • Subjects:
    • Biological products -- Law and legislation -- United States.

    • Edition Notes

      SeriesPublication ;, no. 437, Public Health Service publication ;, no. 437.
      ContributionsNational Institutes of Health (U.S.). Division of Biologics Standards.
      Classifications
      LC ClassificationsKF3894.B5 A3 1967
      The Physical Object
      Paginationvii, 61 p.
      Number of Pages61
      ID Numbers
      Open LibraryOL4404302M
      LC Control Number79006666

      Drugs and devices are defined in the Federal Food Drug and Cosmetics (FD&C) Act—Title 21 Chapter 9. Biological products on the other hand are defined in the Public Health Service (PHS) Act—Title 42 Chapter 6A. Added to these general rules are additional considerations for “human cells, tissues and cellular and tissue-based products. The terms “select agent or toxin” and “entity” have the same meaning as defined in 42 C.F.R. part BACKGROUND. Part 73 of Ti Code of Federal Regulations (Select Agent regulations.

      The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled “Nonproprietary Naming of Biological Products.” The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a. Vaccination schedule was according to the regulations, I.e., 3 doses, ml., 1 week apart with bleeding 1 week after the third dose. t: I, y ; II, ; III, per ml. dose. in emulsified form to other sites of antibody formation, and (c) in the stimulation of formation Cited by: 5.

        (a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. , as amended (42 U.S.C. et seq.)). (b) Exemptions. (1) The clinical investigation of a drug product that is lawfully. Outline. VOLUME A-1a (Title 10) SubChapter E - Food and Drug Products; Research. Part 60 Food And Drug Products. SubPart - WIC Program--Violations and Hearings Involving Applicants, Participants, Food Vendors and Local Agencies.


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Biological products: Public Health Service regulations, title 42, part 73 by United States. Public Health Service. Download PDF EPUB FB2

Electronic Code of Federal Regulations (e-CFR) Title Public Health; Chapter I. PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES; Subchapter F.

QUARANTINE, INSPECTION, LICENSING; Part SELECT AGENTS AND TOXINS. Electronic Code of Federal Regulations (e-CFR) Title Public Health; Chapter I.

PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES animal health or animal products, or plant health or plant products. Overlap select agent and/or toxin means a biological agent or toxin listed in § and 9 CFR part (ii) Section of the Public Health Service Act pertaining to biological products (42 U.S.C.

), or (iii) The Virus-Serum-Toxin Act (21 U.S.C. (6) It is an animal or animal product listed in 42 CFR Part 71 and its importation has been authorized in accordance with 42 CFR, or (g) To apply for a permit, an.

§ Purpose and scope. This part implements the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of setting forth the requirements for possession, use, and transfer of select agents and toxins.

Officials conducting public health investigations also need to be aware that the possession of certain biological agents and toxins determined by the HHS Secretary to have the potential to pose a severe threat to public health and safety is regulated under part 73 of title 42 Code of Federal Regulations.

(a) Clinical or diagnostic laboratories and other entities that possess, use, or transfer a HHS select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the HHS Secretary, within seven calendar days after.

compliance with FDA and other applicable laws and regulations. Biological drug products are licensed under Section of the Public Health Service (PHS) Act (42 U.S.C), and fall within.

From Title THE PUBLIC HEALTH AND WELFARE CHAPTER 6A-PUBLIC HEALTH SERVICE SUBCHAPTER II-GENERAL POWERS AND DUTIES Part F-Licensing of Biological Products and Clinical Laboratories subpart 1 of the Public Health Service Act [42 U.S.C.

a means the Federal regulations found in Part 73 of Title 42 of the Code of Federal Regulations. 19 (k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price 20 Competition and Innovation Act of (BPCI Act). Under (k)(7), licensure of an.

U.S.C. (b) or (j)) and biological products licensed under section of the Public Health Service Act (PHS Act) (42 U.S.C. )), other than biological products that also meet the definition of a. Title(s): Public Health Service regulations: Biological products, title 42 - p and excerpts from the Public Health Service act.

Publication Start Year: Publication End Year: Country of Publication: United States Publisher: Bethesda, Md., U. Division of Biologics Standards of the National Institutes of Health. the Department of Health and Human Services (HHS), issued a Notice of Proposed Rulemaking (NPRM) to implement Section of Public Law"The Antiterrorism and Effective Death Penalty Act of ," which requires the Secretary of HHS to regulate the File Size: KB.

Author(s): National Institutes of Health (U.S.). Division of Biologics Standards. Title(s): Biological products: Public Health Service regulations, ti part 3 Including Biological Products, under or biological products approved under section of the Public Health Service Act (PHS Act) (42 U.S.C.

by FDA regulations. (21 CFR part The primary laws that govern the drug and biological products are shown in Table Some important regulations for drugs, biologics, and medical devices in Ti Code of Federal Regulations (CFR), are shown in Table These laws and regulations are intended to protect the public by: 1.

U.S. Public Health Service Regulations for the Manufacture of Biological Products Department of Health, Education and Welfare, Ti P Publication No. Cited by: 6. This guidance is intended to provide answers to common questions about FDA's implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of Mawill be deemed to be a license for the biological product under the Public Health.

42 CFR Part 54a_Charitable Choice regulations applicable to States, local governments and religious organizations receiving discretionary funding under Title V of the Public Health Service Act, 42 U.S.C.

aa, et seq., for substance abuse prevention and treatment services. The Animal and Plant Health Inspection Service (APHIS) has been designated as the USDA agency responsible for promulgating, implementing, and providing guidance on 9 CFR Part and 7 CFR Part The USDA Select Agent regulations covering threats to plants and plant products can be found at Part of Title 7 Code of Federal Regulations (7.

(a) The regulations in this part and in parts, and of this chapter as they may pertain to a drug; in parts through of this chapter as they may pertain to a biological product for human use; and in part of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is a drug (subject to review under an application.

THIS TITLE. Title 42— Public Health is composed of five volumes. The parts in these volumes are arranged in the following order: Partspartspartspartsand part to end. The first volume (parts ) contains current regulations issued under chapter I—Public Health Service (HHS).

(a) General. To obtain a biologics license under section of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in (a) or (b) of this chapter), on forms prescribed for such purposes, and shall.standards for interchangeability under 42 USC (k)(4).

(b) Until Maa biological drug product that the FDA has determined to be therapeutically equivalent as set forth in "Approved Drug Products with Therapeutic Equivalence Evaluations", an FDA publication that is commonly referred to as the "Orange Book".File Size: KB.