Source: https://law.justia.com/codes/us/2014/title-42/chapter-6a/subchapter-ii/part-f/subpart-1/sec.-262a/
Timestamp: 2019-07-19 23:06:57
Document Index: 100938694

Matched Legal Cases: ['§ 262', 'art 1', '§351', '§201', '§1709', '§ 262', '§351', '§201', '§1709', '§301', '§151', '§136', '§203', '§203', '§205', '§201', '§202']

42 U.S.C. § 262a (2014) - Enhanced control of dangerous biological agents and toxins :: Title 42 - The Public Health and Welfare (Sections 1 - 18445) - US Code :: Justia
Justia US Law US Codes and Statutes US Code 2014 US Code Title 42 - The Public Health and Welfare (Sections 1 - 18445) Chapter 6A - Public Health Service (Sections 201 - 300mm-61) Subchapter II - General Powers and Duties (Sections 241 - 280m) Part F - Licensing of Biological Products and Clinical Laboratories (Sections 262 - 263b) Subpart 1 - Biological Products (Sections 262 - 263) Sec. 262a - Enhanced control of dangerous biological agents and toxins
Sec. 262a - Enhanced control of dangerous biological agents and toxins
Contains section 262a
Source Credit July 1, 1944, ch. 373, title III, §351A, as added Pub. L. 107-188, title II, §201(a), June 12, 2002, 116 Stat. 637; amended Pub. L. 107-296, title XVII, §1709(a), Nov. 25, 2002, 116 Stat. 2318.
Statutes at Large References 37 Stat. 832
110 Stat. 1214
116 Stat. 637, 2318, 646, 647
120 Stat. 2851
Public and Private Laws Public Law 92-516, Public Law 95-452, Public Law 104-132, Public Law 107-188, Public Law 107-296, Public Law 109-417
42 U.S.C. § 262a (2014)
Regulations under subsections (b) and (c) of this section shall provide for a procedure through which, upon request to the Secretary by a registered person who submits names and other identifying information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by the Secretary—
In a review under subparagraph (A), and in any judical 1 proceeding conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) of this section shall not be disclosed under section 552 of title 5.
Regulations under subsections (b) and (c) of this section shall exempt clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that—
(A) Any registration or transfer documentation submitted under subsections (b) and (c) of this section for the possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a specific registered person.
(B) The national database developed pursuant to subsection (d) of this section, or any other compilation of the registration or transfer information submitted under subsections (b) and (c) of this section to the extent that such compilation discloses site-specific registration or transfer information.
(D) Any notification of a release of a listed agent or toxin submitted under subsections (b) and (c) of this section, or any notification of theft or loss submitted under such subsections.
(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under subsection (f) of this section that identifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location of a specific registered person if the agency determines that public disclosure of the information would endanger public health or safety.
(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c) of this section; or
(2) The term "listed agents and toxins" means biological agents and toxins listed pursuant to subsection (a)(1) of this section.
(3) The term "listed agents or toxins" means biological agents or toxins listed pursuant to subsection (a)(1) of this section.
(4) The term "overlap agents and toxins" means biological agents and toxins that—
(A) are listed pursuant to subsection (a)(1) of this section; and
(5) The term "overlap agent or toxin" means a biological agent or toxin that—
(A) is listed pursuant to subsection (a)(1) of this section; and
(7) The term "registered person" means a person registered under regulations under subsection (b) or (c) of this section.
(July 1, 1944, ch. 373, title III, §351A, as added Pub. L. 107–188, title II, §201(a), June 12, 2002, 116 Stat. 637; amended Pub. L. 107–296, title XVII, §1709(a), Nov. 25, 2002, 116 Stat. 2318.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.(g)(2)(B)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
The Act commonly known as the Virus-Serum-Toxin Act, referred to in subsec. (g)(2)(B)(iii), is the eighth paragraph under the heading "Bureau of Animal Industry" of act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is classified generally to chapter 5 (§151 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 151 of Title 21 and Tables.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsec. (g)(2)(B)(iv), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.
Pub. L. 107–188, title II, §203(b), June 12, 2002, 116 Stat. 647, provided that: "Subsection (h) of section 351A of the Public Health Service Act [42 U.S.C. 262a(h)], as added by section 201 of this Act, is deemed to have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub. L. 104–132, Apr. 24, 1996, 110 Stat. 1214]."
Pub. L. 107–188, title II, §203(a), June 12, 2002, 116 Stat. 647, provided that: "Regulations promulgated by the Secretary of Health and Human Services under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub. L. 104–132, 42 U.S.C. 262 note] are deemed to have been promulgated under section 351A of the Public Health Service Act [42 U.S.C. 262a], as added by section 201 of this Act. Such regulations, including the list under [former] subsection (d)(1) of such section 511, that were in effect on the day before the date of the enactment of this Act [June 12, 2002] remain in effect until modified by the Secretary in accordance with such section 351A and with section 202 of this Act [set out as a note below]."
Pub. L. 109–417, title II, §205, Dec. 19, 2006, 120 Stat. 2851, provided that: "The National Science Advisory Board for Biosecurity shall, when requested by the Secretary of Health and Human Services, provide to relevant Federal departments and agencies, advice, guidance, or recommendations concerning—
Pub. L. 107–188, title II, §201(b), June 12, 2002, 116 Stat. 646, required the Secretary of Health and Human Services to report to Congress not later than one year after June 12, 2002, on the implementation, compliance, and future plans under this section.
Pub. L. 107–188, title II, §202, June 12, 2002, 116 Stat. 646, provided that:
"(a) Date Certain for Notice of Possession.—Not later than 90 days after the date of the enactment of this Act [June 12, 2002], all persons (unless exempt under subsection (g) of section 351A of the Public Health Service Act [42 U.S.C. 262a(g)], as added by section 201 of this Act) in possession of biological agents or toxins listed under such section 351A of the Public Health Service Act [42 U.S.C. 262a] shall notify the Secretary of Health and Human Services of such possession. Not later than 30 days after such date of enactment, the Secretary shall provide written guidance on how such notice is to be provided to the Secretary.
"(b) Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.—Not later than 180 days after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate an interim final rule for carrying out section 351A of the Public Health Service Act [42 U.S.C. 262a], subject to subsection (c). Such interim final rule shall take effect 60 days after the date on which such rule is promulgated, including for purposes of—
"(c) Transitional Provision Regarding Current Research and Education.—The interim final rule under subsection (b) shall include time frames for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents and toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act [42 U.S.C. 262a(a)(1)] and that were underway as of the effective date of such rule."