42 USC 262a(h)(1)(C): Customs and duties
About This Project
This project uses data compiled by the Sunshine in Government initiative, a coalition of journalism and transparency groups. SGI compiled data from federal agency annual FOIA reports to track how often b(3) exemptions were used. SGI also standardized the exemptions since some agencies used slightly different citations of the same laws. In some cases, agencies listed general laws without specifying a section under which information was withheld. This project does not include information from agencies that use no b(3) exemptions in 2008 or 2009. ProPublica compiled information about FOIA denials.
| Department | Claims |
|---|---|
| Dept. of Health and Human Services | 20.0 |
| Dept. of Defense | 5.0 |
TITLE 42--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--biological products
Sec. 262a. Enhanced control of dangerous biological agents and
toxins
(a) Regulatory control of certain biological agents and toxins
(1) List of biological agents and toxins
(A) In general
The Secretary shall by regulation establish and maintain a
list of each biological agent and each toxin that has the
potential to pose a severe threat to public health and safety.
(B) Criteria
In determining whether to include an agent or toxin on the
list under subparagraph (A), the Secretary shall--
(i) consider--
(I) the effect on human health of exposure to the
agent or toxin;
(II) the degree of contagiousness of the agent or
toxin and the methods by which the agent or toxin is
transferred to humans;
(III) the availability and effectiveness of
pharmacotherapies and immunizations to treat and prevent
any illness resulting from infection by the agent or
toxin; and
(IV) any other criteria, including the needs of
children and other vulnerable populations, that the
Secretary considers appropriate; and
(ii) consult with appropriate Federal departments and
agencies and with scientific experts representing
appropriate professional groups, including groups with
pediatric expertise.
(2) Biennial review
The Secretary shall review and republish the list under
paragraph (1) biennially, or more often as needed, and shall by
regulation revise the list as necessary in accordance with such
paragraph.
(b) Regulation of transfers of listed agents and toxins
The Secretary shall by regulation provide for--
(1) the establishment and enforcement of safety procedures for
the transfer of listed agents and toxins, including measures to
ensure--
(A) proper training and appropriate skills to handle such
agents and toxins; and
(B) proper laboratory facilities to contain and dispose of
such agents and toxins;
(2) the establishment and enforcement of safeguard and security
measures to prevent access to such agents and toxins for use in
domestic or international terrorism or for any other criminal
purpose;
(3) the establishment of procedures to protect the public safety
in the event of a transfer or potential transfer of such an agent or
toxin in violation of the safety procedures established under
paragraph (1) or the safeguard and security measures established
under paragraph (2); and
(4) appropriate availability of biological agents and toxins for
research, education, and other legitimate purposes.
(c) Possession and use of listed agents and toxins
The Secretary shall by regulation provide for the establishment and
enforcement of standards and procedures governing the possession and use
of listed agents and toxins, including the provisions described in
paragraphs (1) through (4) of subsection (b) of this section, in order
to protect the public health and safety.
(d) Registration; identification; database
(1) Registration
Regulations under subsections (b) and (c) of this section shall
require registration with the Secretary of the possession, use, and
transfer of listed agents and toxins, and shall include provisions
to ensure that persons seeking to register under such regulations
have a lawful purpose to possess, use, or transfer such agents and
toxins, including provisions in accordance with subsection (e)(6) of
this section.
(2) Identification; database
Regulations under subsections (b) and (c) of this section shall
require that registration include (if available to the person
registering) information regarding the characterization of listed
agents and toxins to facilitate their identification, including
their source. The Secretary shall maintain a national database that
includes the names and locations of registered persons, the listed
agents and toxins such persons are possessing, using, or
transferring, and information regarding the characterization of such
agents and toxins.
(e) Safeguard and security requirements for registered persons
(1) In general
Regulations under subsections (b) and (c) of this section shall
include appropriate safeguard and security requirements for persons
possessing, using, or transferring a listed agent or toxin
commensurate with the risk such agent or toxin poses to public
health and safety (including the risk of use in domestic or
international terrorism). The Secretary shall establish such
requirements in collaboration with the Secretary of Homeland
Security and the Attorney General, and shall ensure compliance with
such requirements as part of the registration system under such
regulations.
(2) Limiting access to listed agents and toxins
Requirements under paragraph (1) shall include provisions to
ensure that registered persons--
(A) provide access to listed agents and toxins to only those
individuals whom the registered person involved determines have
a legitimate need to handle or use such agents and toxins;
(B) submit the names and other identifying information for
such individuals to the Secretary and the Attorney General,
promptly after first determining that the individuals need
access under subparagraph (A), and periodically thereafter while
the individuals have such access, not less frequently than once
every five years;
(C) deny access to such agents and toxins by individuals
whom the Attorney General has identified as restricted persons;
and
(D) limit or deny access to such agents and toxins by
individuals whom the Attorney General has identified as within
any category under paragraph (3)(B)(ii), if limiting or denying
such access by the individuals involved is determined
appropriate by the Secretary, in consultation with the Attorney
General.
(3) Submitted names; use of databases by attorney general
(A) In general
Upon the receipt of names and other identifying information
under paragraph (2)(B), the Attorney General shall, for the sole
purpose of identifying whether the individuals involved are
within any of the categories specified in subparagraph (B),
promptly use criminal, immigration, national security, and other
electronic databases that are available to the Federal
Government and are appropriate for such purpose.
(B) Certain individuals
For purposes of subparagraph (A), the categories specified
in this subparagraph regarding an individual are that--
(i) the individual is a restricted person; or
(ii) the individual is reasonably suspected by any
Federal law enforcement or intelligence agency of--
(I) committing a crime set forth in section
2332b(g)(5) of title 18;
(II) knowing involvement with an organization that
engages in domestic or international terrorism (as
defined in section 2331 of such title 18) or with any
other organization that engages in intentional crimes of
violence; or
(III) being an agent of a foreign power (as defined
in section 1801 of title 50).
(C) Notification by Attorney General regarding submitted names
After the receipt of a name and other identifying
information under paragraph (2)(B), the Attorney General shall
promptly notify the Secretary whether the individual is within
any of the categories specified in subparagraph (B).
(4) Notifications by Secretary
The Secretary, after receiving notice under paragraph (3)
regarding an individual, shall promptly notify the registered person
involved of whether the individual is granted or denied access under
paragraph (2). If the individual is denied such access, the
Secretary shall promptly notify the individual of the denial.
(5) Expedited review
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--
(A) request the Attorney General to expedite the process of
identification under paragraph (3)(A) and notification of the
Secretary under paragraph (3)(C); and
(B) expedite the notification of the registered person by
the Secretary under paragraph (4).
(6) Process regarding persons seeking to register
(A) Individuals
Regulations under subsections (b) and (c) of this section
shall provide that an individual who seeks to register under
either of such subsections is subject to the same processes
described in paragraphs (2) through (4) as apply to names and
other identifying information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not apply for
purposes of this subparagraph.
(B) Other persons
Regulations under subsections (b) and (c) of this section
shall provide that, in determining whether to deny or revoke
registration by a person other than an individual, the Secretary
shall submit the name of such person to the Attorney General,
who shall use criminal, immigration, national security, and
other electronic databases available to the Federal Government,
as appropriate for the purpose of promptly notifying the
Secretary whether the person, or, where relevant, the individual
who owns or controls such person, is a restricted person or is
reasonably suspected by any Federal law enforcement or
intelligence agency of being within any category specified in
paragraph (3)(B)(ii) (as applied to persons, including
individuals). Such regulations shall provide that a person who
seeks to register under either of such subsections is subject to
the same processes described in paragraphs (2) and (4) as apply
to names and other identifying information submitted to the
Attorney General under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The Secretary may
exempt Federal, State, or local governmental agencies from the
requirements of this subparagraph.
(7) Review
(A) Administrative review
(i) In general
Regulations under subsections (b) and (c) of this
section shall provide for an opportunity for a review by the
Secretary--
(I) when requested by the individual involved, of a
determination under paragraph (2) to deny the individual
access to listed agents and toxins; and
(II) when requested by the person involved, of a
determination under paragraph (6) to deny or revoke
registration for such person.
(ii) Ex parte review
During a review under clause (i), the Secretary may
consider information relevant to the review ex parte to the
extent that disclosure of the information could compromise
national security or an investigation by any law enforcement
agency.
(iii) Final agency action
The decision of the Secretary in a review under clause
(i) constitutes final agency action for purposes of section
702 of title 5.
(B) Certain procedures
(i) Submission of ex parte materials in judicial
proceedings
When reviewing a decision of the Secretary under
subparagraph (A), and upon request made ex parte and in
writing by the United States, a court, upon a sufficient
showing, may review and consider ex parte documents
containing information the disclosure of which could
compromise national security or an investigation by any law
enforcement agency. If the court determines that portions of
the documents considered ex parte should be disclosed to the
person involved to allow a response, the court shall
authorize the United States to delete from such documents
specified items of information the disclosure of which could
compromise national security or an investigation by any law
enforcement agency, or to substitute a summary of the
information to which the person may respond. Any order by
the court authorizing the disclosure of information that the
United States believes could compromise national security or
an investigation by any law enforcement agency shall be
subject to the processes set forth in subparagraphs (A) and
(B)(i) of section 2339B(f)(5) of title 18 (relating to
interlocutory appeal and expedited consideration).
(ii) Disclosure of information
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.
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\1\ So in original. Probably should be ``judicial''.
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(8) Notifications regarding theft or loss of agents
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State, and
local law enforcement agencies, of the theft or loss of listed
agents and toxins.
(9) Technical assistance for registered persons
The Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
(f) Inspections
The Secretary shall have the authority to inspect persons subject to
regulations under subsection (b) or (c) of this section to ensure their
compliance with such regulations, including prohibitions on restricted
persons and other provisions of subsection (e) of this section.
(g) Exemptions
(1) Clinical or diagnostic laboratories
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) the identification of such agents or toxins is reported
to the Secretary, and when required under Federal, State, or
local law, to other appropriate authorities; and
(B) such agents or toxins are transferred or destroyed in a
manner set forth by the Secretary by regulation.
(2) Products
(A) In general
Regulations under subsections (b) and (c) of this section
shall exempt products that are, bear, or contain listed agents
or toxins and are cleared, approved, licensed, or registered
under any of the Acts specified in subparagraph (B), unless the
Secretary by order determines that applying additional
regulation under subsection (b) or (c) of this section to a
specific product is necessary to protect public health and
safety.
(B) Relevant laws
For purposes of subparagraph (A), the Acts specified in this
subparagraph are the following:
(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.].
(ii) Section 262 of this title.
(iii) The Act commonly known as the Virus-Serum-Toxin
Act (the eighth paragraph under the heading ``Bureau of
Animal Industry'' in the Act of March 4, 1913; 21 U.S.C.
151-159).
(iv) The Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.].
(C) Investigational use
(i) In general
The Secretary may exempt an investigational product that
is, bears, or contains a listed agent or toxin from the
applicability of provisions of regulations under subsection
(b) or (c) of this section when such product is being used
in an investigation authorized under any Federal Act and the
Secretary determines that applying additional regulation
under subsection (b) or (c) of this section to such product
is not necessary to protect public health and safety.
(ii) Certain processes
Regulations under subsections (b) and (c) of this
section shall set forth the procedures for applying for an
exemption under clause (i). In the case of investigational
products authorized under any of the Acts specified in
subparagraph (B), the Secretary shall make a determination
regarding a request for an exemption not later than 14 days
after the first date on which both of the following
conditions have been
met by the person requesting the exemption:
(I) The person has submitted to the Secretary an
application for the exemption meeting the requirements
established by the Secretary.
(II) The person has notified the Secretary that the
investigation has been authorized under such an Act.
(3) Public health emergencies
The Secretary may temporarily exempt a person from the
applicability of the requirements of this section, in whole or in
part, if the Secretary determines that such exemption is necessary
to provide for the timely participation of the person in a response
to a domestic or foreign public health emergency (whether determined
under section 247d(a) of this title or otherwise) that involves a
listed agent or toxin. With respect to the emergency involved, such
exemption for a person may not exceed 30 days, except that the
Secretary, after review of whether such exemption remains necessary,
may provide one extension of an additional 30 days.
(4) Agricultural emergencies
Upon request of the Secretary of Agriculture, after the granting
by such Secretary of an exemption under section 8401(g)(1)(D) of
title 7 pursuant to a finding that there is an agricultural
emergency, the Secretary of Health and Human Services may
temporarily exempt a person from the applicability of the
requirements of this section, in whole or in part, to provide for
the timely participation of the person in a response to the
agricultural emergency. With respect to the emergency involved, the
exemption under this paragraph for a person may not exceed 30 days,
except that upon request of the Secretary of Agriculture, the
Secretary of Health and Human Services may, after review of whether
such exemption remains necessary, provide one extension of an
additional 30 days.
(h) Disclosure of information
(1) Nondisclosure of certain information
No Federal agency specified in paragraph (2) shall disclose
under section 552 of title 5 any of the following:
(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.
(C) Any portion of a record that discloses the site-specific
or transfer-specific safeguard and security measures used by a
registered person to prevent unauthorized access to listed
agents and toxins.
(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.
(2) Covered agencies
For purposes of paragraph (1) only, the Federal agencies
specified in this paragraph are the following:
(A) The Department of Health and Human Services, the
Department of Justice, the Department of Agriculture, and the
Department of Transportation.
(B) Any Federal agency to which information specified in
paragraph (1) is transferred by any agency specified in
subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person, or has a
sub-agency component that is a registered person.
(D) Any Federal agency that awards grants or enters into
contracts or cooperative agreements involving listed agents and
toxins to or with a registered person, and to which information
specified in paragraph (1) is transferred by any such registered
person.
(3) Other exemptions
This subsection may not be construed as altering the application
of any exemptions to public disclosure under section 552 of title 5,
except as to subsection \2\ 552(b)(3) of such title, to any of the
information specified in paragraph (1).
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\2\ So in original. Probably should be ``section''.
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(4) Rule of construction
Except as specifically provided in paragraph (1), this
subsection may not be construed as altering the authority of any
Federal agency to withhold under section 552 of title 5, or the
obligation of any Federal agency to disclose under section 552 of
title 5, any information, including information relating to--
(A) listed agents and toxins, or individuals seeking access
to such agents and toxins;
(B) registered persons, or persons seeking to register their
possession, use, or transfer of such agents and toxins;
(C) general safeguard and security policies and requirements
under regulations under subsections (b) and (c) of this section;
or
(D) summary or statistical information concerning
registrations, registrants, denials or revocations of
registrations, listed agents and toxins, inspection evaluations
and reports, or individuals seeking access to such agents and
toxins.
(5) Disclosures to Congress; other disclosures
This subsection may not be construed as providing any
authority--
(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
(B) to withhold information from any person under any other
Federal law or treaty.
(i) Civil money penalty
(1) In general
In addition to any other penalties that may apply under law, any
person who violates any provision of regulations under subsection
(b) or (c) of this section shall be subject to the United States for
a civil money penalty in an amount not exceeding $250,000 in the
case of an individual and $500,000 in the case of any other person.
(2) Applicability of certain provisions
The provisions of section 1320a-7a of this title (other than
subsections (a), (b), (h), and (i), the first sentence of subsection
(c), and paragraphs (1) and (2) of subsection (f)) shall apply to a
civil money penalty under paragraph (1) in the same manner as such
provisions apply to a penalty or proceeding under section 1320a-
7a(a) of this title. The Secretary may delegate authority under this
subsection in the same manner as provided in section 1320a-7a(j)(2)
of this title, and such authority shall include all powers as
contained in section 6 of the Inspector General Act of 1978 (5
U.S.C. App.).
(j) Notification in event of release
Regulations under subsections (b) and (c) of this section shall
require the prompt notification of the Secretary by a registered person
whenever a release, meeting criteria established by the Secretary, of a
listed agent or toxin has occurred outside of the biocontainment area of
a facility of the registered person. Upon receipt of such notification
and a finding by the Secretary that the release poses a threat to public
health or safety, the Secretary shall take appropriate action to notify
relevant State and local public health authorities, other relevant
Federal authorities, and, if necessary, other appropriate persons
(including the public). If the released listed agent or toxin is an
overlap agent or toxin (as defined in subsection (l) of this section),
the Secretary shall promptly notify the Secretary of Agriculture upon
notification by the registered person.
(k) Reports
The Secretary shall report to the Congress annually on the number
and nature of notifications received under subsection (e)(8) of this
section (relating to theft or loss) and subsection (j) of this section
(relating to releases).
(l) Definitions
For purposes of this section:
(1) The terms ``biological agent'' and ``toxin'' have the
meanings given such terms in section 178 of title 18.
(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
(B) are listed pursuant to section 8401(a)(1) of title 7.
(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
(B) is listed pursuant to section 8401(a)(1) of title 7.
(6) The term ``person'' includes Federal, State, and local
governmental entities.
(7) The term ``registered person'' means a person registered
under regulations under subsection (b) or (c) of this section.
(8) The term ``restricted person'' has the meaning given such
term in section 175b of title 18.
(m) Authorization of appropriations
For the purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for each of the fiscal
years 2002 through 2007.
(July 1, 1944, ch. 373, title III, Sec. 351A, as added Pub. L. 107-188,
title II, Sec. 201(a), June 12, 2002, 116 Stat. 637; amended Pub. L.
107-296, title XVII, Sec. 1709(a), Nov. 25, 2002, 116 Stat. 2318.)
References in Text
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 (Sec. 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 (Sec. 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 (Sec. 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.
Section 6 of the Inspector General Act of 1978, referred to in
subsec. (i)(2), is section 6 of Pub. L. 95-452, which is set out in the
Appendix to Title 5, Government Organization and Employees.
Amendments
2002--Subsec. (e)(1). Pub. L. 107-296 substituted ``collaboration
with the Secretary of Homeland Security and'' for ``consultation with''.
Effective Date of 2002 Amendment
Amendment by Pub. L. 107-296 effective 60 days after Nov. 25, 2002,
see section 4 of Pub. L. 107-296, set out as an Effective Date note
under section 101 of Title 6, Domestic Security.
Effective Date
Pub. L. 107-188, title II, Sec. 203(b), June 12, 2002, 116 Stat.
647, provided that: ``Subsection (h) of section 351A of the Public
Health Service Act [subsec. (h) of this sec
tion], 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].''
Regulations
Pub. L. 107-188, title II, Sec. 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, set out as a note under
section 262 of this title] are deemed to have been promulgated under
section 351A of the Public Health Service Act [this section], 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].''
National Science Advisory Board for Biosecurity
Pub. L. 109-417, title II, Sec. 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--
``(1) a core curriculum and training requirements for workers in
maximum containment biological laboratories; and
``(2) periodic evaluations of maximum containment biological
laboratory capacity nationwide and assessments of the future need
for increased laboratory capacity.''
Report to Congress
Pub. L. 107-188, title II, Sec. 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.
Implementation by Department of Health and Human Services
Pub. L. 107-188, title II, Sec. 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 [subsec. (g) of this section], 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 [this section] 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 [this section], 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--
``(1) section 175b(c) of title 18, United States Code (relating
to criminal penalties), as added by section 231(a)(5) of this Act;
and
``(2) section 351A(i) of the Public Health Service Act [subsec.
(i) of this section] (relating to civil penalties).
``(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 [subsec. (a)(1) of this section] and that were underway as
of the effective date of such rule.''