In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Ex Input:
OF CONFLICTS.

To the extent permitted by law, disagreements or conflicts between
or among agency heads or between OMB and any agency that cannot be
resolved by the Administrator of OIRA shall be resolved by the
President or a designee of the President.

SEC. 8. PUBLICATION.

Except to the extent required by law, an agency shall not publish
in the Federal Register or otherwise issue to the public any regulatory
action that is subject to review under section 6 until--
(1) the Administrator of OIRA notifies the agency that OIRA
has waived its review of the action or has completed its review
without any requests for further consideration, or
(2) the applicable time period in section 6(b)(2) expires
without OIRA having notified the agency that it is returning
the regulatory action for further consideration under section
6(b)(3),
whichever occurs first. If the terms of the preceding sentence have not
been satisfied and an agency wants to publish or otherwise issue a
regulatory action, the head of that agency may request Presidential
consideration through the Administrator of OIRA, as provided under
section 8. Upon receipt of this request, the Administrator of OIRA
shall notify the Advisers. The guidelines and time period set forth in
section 8 shall apply to the publication of regulatory actions for
which Presidential consideration has been sought.

SEC. 9. AGENCY AUTHORITY.

Nothing in this Act shall be construed as displacing the agencies'
authority or responsibilities, as authorized by law.

SEC. 10. JUDICIAL REVIEW.

Nothing in this Act shall affect any otherwise available judicial
review of agency action. This Act is intended only to improve the
internal management of the Federal Government and does not create any
right or benefit, substantive or procedural, enforceable at law or
equity by a party against the United States, its agencies or
instrumentalities, its officers or employees, or any other person.

SEC. 11. DEFINITIONS.

For purposes of this Act:
(1) The term ''Advisers'' refers to such regulatory policy
advisers to the President as the President and the
Administrator of OIRA may from time to time consult, including,
among others--
(A) the Director of OMB;
(B) the Chair (or another member) of the Council of
Economic Advisers;
(C) the Assistant to the President for Economic
Policy;
(D) the Assistant to the President for Domestic
Policy;
(E) the Assistant to the President for National
Security Affairs;
(F) the Assistant to the President for Science and
Technology;
(G) the Assistant to the President for
Intergovernmental Affairs;
(H) the Assistant to the President and Staff
Secretary;
(I) the Assistant to the President and Chief of
Staff to the Administrator of OIRA;
(J) the Assistant to the President and Counsel to
the President; and
(K) the Deputy Assistant to the President and
Director of the White House Office on Environmental
Policy.
(2) Except as provided in section 4(f), the term ''agency''
means any authority of the United States that is an ''agency''
under section 3502(1) of title 44, United States Code, other
than those considered to be independent regulatory agencies, as
defined in section 3502(10) of title 44, United States Code.
(3) The term ''Director'' means the Director of OMB.
(4) The term ''regulation'' or ''rule'' means an agency
statement of general applicability and future effect, which the
agency intends to have the force and effect of law, that is
designed to implement, interpret, or prescribe law or policy or
to describe the procedure or practice requirements of an
agency. It does not, however, include--
(A) regulations or rules issued in accordance with
the formal rulemaking provisions of sections 556 and
557 of title 5, United States Code;
(B) regulations or rules that pertain to a military
or foreign affairs function of the United States, other
than procurement regulations and regulations involving
the import or export of non-defense articles and
services;
(C) regulations or rules that are limited to agency
organization, management, or personnel matters; or
(D) any other category of regulations exempted by
the Administrator of OIRA.
(5) The term ''regulatory action'' means any substantive
action by an agency (normally published in the Federal
Register) that promulgates or is expected to lead to the
promulgation of a final rule or regulation, including notices
of inquiry, advance notices of proposed rulemaking, and notices
of proposed rulemaking.
(6) The term ''significant regulatory action'' means any
regulatory action that is likely to result in a rule that may--
(A) have an annual effect on the economy of $100
million or more or adversely affect in a material way
the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or
communities;
(B) create a serious inconsistency or otherwise
interfere with an action taken or planned by another
agency;
(C) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or
(D) raise novel legal or policy issues arising out
of legal mandates, the President's priorities, or the
principles set forth in this Act.

Ex Output:
Government Regulatory Improvement and Performance Act of 1998 - Declares that: (1) Federal agencies should promulgate only such regulations as are required by law, necessary to interpret the law, or necessary to protect and promote or improve the health and safety of the public, the environment, or the well-being of the American people; and (2) in deciding whether and how to regulate, agencies should assess all costs and benefits of available regulatory alternatives, including the alternative of not regulating.
Sets forth principles of regulation to ensure that the agencies' regulatory programs are consistent with such philosophy, including that each agency: (1) identify the problem that it intends to address by regulation, assess its significance, and if possible conduct a risk analysis; (2) identify and assess available alternatives to direct regulation; (3) wherever feasible, seek views of appropriate State, local, and tribal officials before imposing requirements that might significantly or uniquely affect those governmental entities.
(Sec. 3) Directs the Office of Management and Budget to carry out coordinated review of agency rulemaking. Designates its Office of Information and Regulatory Affairs (OIRA) as the repository of expertise concerning regulatory issues.
(Sec. 4) Directs the OIRA Administrator, early in each year's planning cycle, to convene a meeting of the regulatory policy advisers to the President and agency heads to seek a common understanding of priorities and to coordinate regulatory efforts for the upcoming year.
Requires each agency to prepare: (1) a unified regulatory agenda of all regulations under development or review; and (2) a regulatory plan of the most important significant regulatory actions that the agency reasonably expects to issue in that fiscal year or thereafter.
Directs the Administrator to: (1) convene and chair a regulatory working group, which shall meet at least quarterly, to assist agencies in identifying and analyzing important regulatory issues; (2) meet quarterly, along with agency heads, with representatives of State, local, and tribal governments to identify exiting and proposed regulations that may uniquely or significantly affect those governmental entities; and (3) convene periodic conferences with representatives of businesses, nongovernmental organizations, and the public to discuss regulatory issues.
(Sec. 5) Requires that: (1) each agency submit to OIRA a program under which the agency will periodically review its existing significant regulations; and (2) any significant regulations selected for review be included in the agency's annual plan, and the agency identify any legislative mandates that require the agency to promulgate or continue to impose unnecessary or outdated regulations.
(Sec. 5) Requires each agency to: (1) submit to the OIRA a program under which the agency will periodically review its existing significant regulations for possible modification or elimination; (2) provide the public with meaningful participation in the regulatory process and a meaningful opportunity to comment on any proposed regulation, generally including a comment period of not less than 60 days; and (2) explore and, where appropriate, use consensual mechanisms for developing regulations, including negotiated rulemaking.
Directs: (1) each agency head to designate a Regulatory Policy Office; (2) each agency to develop its regulatory actions in a timely fashion and adhere to specified procedures; (3) each agency to provide the OIRA with a list of its planned regulatory actions, including significant regulatory actions; and (4) the Administrator to provide meaningful guidance and oversight.
(Sec. 8) Prohibits an agency from publishing a regulation until the Administrator has waived review of the action, completed such review, or the review period has passed, whichever occurs first.

Ex Input:
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Drug Competition Act of 2002''.

SEC. 2. FINDINGS.

Congress finds that--
(1) prescription drug prices are increasing at an alarming
rate and are a major worry of many senior citizens and American
families;
(2) there is a potential for companies with patent rights
regarding brand name drugs and companies which could
manufacture generic versions of such drugs to enter into
financial deals that could tend to restrain trade and greatly
reduce competition and increase prescription drug expenditures
for American citizens; and
(3) enhancing competition among these companies can
significantly reduce prescription drug expenditures for
Americans.

SEC. 3. PURPOSES.

The purposes of this Act are--
(1) to provide timely notice to the Department of Justice
and the Federal Trade Commission regarding agreements between
companies with patent rights regarding brand name drugs and
companies which could manufacture generic versions of such
drugs; and
(2) by providing timely notice, to enhance the
effectiveness and efficiency of the enforcement of the
antitrust and competition laws of the United States.

SEC. 4. DEFINITIONS.

In this Act:
(1) ANDA.--The term ''ANDA'' means an Abbreviated New Drug
Application, as defined under section 201(aa) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
(2) Assistant attorney general.--The term ''Assistant
Attorney General'' means the Assistant Attorney General in
charge of the Antitrust Division of the Department of Justice.
(3) Brand name drug.--The term ''brand name drug'' means a
drug approved under section 505(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(c)).
(4) Brand name drug company.--The term ''brand name drug
company'' means the party that received Food and Drug
Administration approval to market a brand name drug pursuant to
an NDA, where that drug is the subject of an ANDA, or a party
owning or controlling enforcement of any patent listed in the
Approved Drug Products With Therapeutic Equivalence Evaluations
of the Food and Drug Administration for that drug, under
section 505(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)).
(5) Commission.--The term ''Commission'' means the Federal
Trade Commission.
(6) Generic drug.--The term ''generic drug'' means a
product that the Food and Drug Administration has approved
under section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)).
(7) Generic drug applicant.--The term ''generic drug
applicant'' means a person who has filed or received approval
for an ANDA under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)).
(8) NDA.--The term ''NDA'' means a New Drug Application, as
defined under section 505(b) et seq. of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b) et seq.)

SEC. 5. NOTIFICATION OF AGREEMENTS.

(a) In General.--
(1) Requirement.--A generic drug applicant that has
submitted an ANDA containing a certification under section
505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug company
that enter into an agreement described in paragraph (2), prior
to the generic drug that is the subject of the application
entering the market, shall each file the agreement as required
by subsection (b).
(2) Definition.--An agreement described in this paragraph
is an agreement regarding--
(A) the manufacture, marketing or sale of the brand
name drug that is the subject of the generic drug
applicant's ANDA;
(B) the manufacture, marketing or sale of the
generic drug that is the subject of the generic drug
applicant's ANDA; or
(C) the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) as it applies
to such ANDA or to any other ANDA based on the same
brand name drug.
(b) Filing.--
(1) Agreement.--The generic drug applicant and the brand
name drug company entering into an agreement described in
subsection (a)(2) shall file with the Assistant Attorney
General and the Commission the text of any such agreement,
except that the generic drug applicant and the brand-name drug
company shall not be required to file an agreement that solely
concerns--
(A) purchase orders for raw material supplies;
(B) equipment and facility contracts;
(C) employment or consulting contracts; or
(D) packaging and labeling contracts.
(2) Other agreements.--The generic drug applicant and the
brand name drug company entering into an agreement described in
subsection (a)(2) shall file with the Assistant Attorney
General and the Commission the text of any other agreements not
described in subsection (a)(2) between the generic drug
applicant and the brand name drug company which are contingent
upon, provide a contingent condition for, or are otherwise
related to an agreement which must be filed under this Act.
(3) Description.--In the event that any agreement required
to be filed by paragraph (1) or (2) has not been reduced to
text, both the generic drug applicant and the brand name drug
company shall file written descriptions of the non-textual
agreement or agreements that must be filed sufficient to reveal
all of the terms of the agreement or agreements.

SEC. 6. FILING DEADLINES.

Any filing required under section 5 shall be filed with the
Assistant Attorney General and the Commission not later than 10
business days after the date the agreements are executed.

SEC. 7. DISCLOSURE EXEMPTION.

Any information or documentary material filed with the Assistant
Attorney General or the Commission pursuant to this Act shall be exempt
from disclosure under section 552 of title 5, and no such information
or documentary material may be made public, except as may be relevant
to any administrative or judicial action or proceeding. Nothing in this
section is intended to prevent disclosure to either body of Congress or
to any duly authorized committee or subcommittee of the Congress.

SEC. 8. ENFORCEMENT.

(a) Civil Penalty.--Any brand name drug company or generic drug
applicant which fails to comply with any provision of this Act shall be
liable for a civil penalty of not more than $11,000, for each day
during which such entity is in violation of this Act. Such penalty may
be recovered in a civil action brought by the United States, or brought
by the Commission in accordance with the procedures established in
section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)).
(b) Compliance and Equitable Relief.--If any brand name drug
company or generic drug applicant fails to comply with any provision of
this Act, the United States district court may order compliance, and
may grant such other equitable relief as the court in its discretion
determines necessary or appropriate, upon application of the Assistant
Attorney General or the Commission.

SEC. 9. RULEMAKING.

The Commission, with the concurrence of the Assistant Attorney
General and by rule in accordance with section 553 of title 5 United
States Code, consistent with the purposes of this Act--
(1) may define the terms used in this Act;
(2) may exempt classes of persons or agreements from the
requirements of this Act; and
(3) may prescribe such other rules as may be necessary and
appropriate to carry out the purposes of this Act.

SEC. 10. SAVINGS CLAUSE.

Any action taken by the Assistant Attorney General or the
Commission, or any failure of the Assistant Attorney General or the
Commission to take action, under this Act shall not bar any proceeding
or any action with respect to any agreement between a brand name drug
company and a generic drug applicant at any time under any other
provision of law, nor shall any filing under this Act constitute or
create a presumption of any violation of any antitrust or competition
laws.

SEC. 11. EFFECTIVE DATE.

This Act shall--
(1) take effect 30 days after the date of enactment of this
Act; and
(2) shall apply to agreements described in section 5 that
are entered into 30 days after the date of enactment of this
Act.

Passed the Senate November 18, 2002.

Attest:

JERI THOMSON,

Secretary.

Ex Output:
Drug Competition Act of 2002 - (Sec. 5) Requires a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA) and a brand name drug company that enter into an agreement, prior to the generic drug entering the market, regarding the manufacture, marketing, or sale of the brand name or the generic drug, or regarding the 180-day semi-exclusivity period referred to in the Federal Food, Drug, and Cosmetic Act as it applies to such ANDA or any other ANDA based on the same brand name drug, to each file such agreement and any related agreements with the Assistant Attorney General and the Federal Trade Commission (FTC). Makes an exception for agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, or employment or consulting contracts. Requires such agreements to be filed not later than ten business days after the date they are executed.(Sec. 7) Exempts any such information or documentary material filed from disclosure under the Freedom of Information Act. Prohibits such information or material from being made public, except as relevant to any administrative or judicial action or proceeding.(Sec. 8) Subjects an applicant or company to a civil penalty of up to $11,000 for each day such entity fails to comply with this Act, recoverable in a civil action brought by the United States or the FTC. Authorizes a U.S. district court to order compliance and grant equitable relief.

Ex Input:
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Security Before Access Act of
2013''.

SEC. 2. PROTECTING THE PRIVACY OF PERSONALLY IDENTIFIABLE INFORMATION
IN ENROLLMENT ACTIVITIES OF HEALTH INSURANCE EXCHANGES.

(a) In General.--Section 340A(c) of the Public Health Service Act
(42 U.S.C. 256a(c)) is amended by adding at the end the following new
paragraph:
''(3) Ensuring privacy of personally identifiable
information; liability; penalties; consumer opt out.--
''(A) In general.--The Secretary shall require each
recipient of a grant under this section to implement
procedures specified by the Secretary consistent with
this paragraph in order protect the privacy of
personally identifiable information.
''(B) Required procedures.--The procedures
specified by the Secretary under subparagraph (A) shall
include at least the following:
''(i) Prohibition of access without
explicit consent.--No certified application
counselor, health insurance navigator, or non-
navigator assistance personnel shall have
access to personally identifiable information
relating to an individual without the express,
witnessed, written consent of that individual.
''(ii) Requiring licensure, background
checks.--No such individual shall have access
to personally identifiable information unless
the individual--
''(I) has undergone, within 60 days
before commencing enrollment assistance
for any consumer seeking coverage
through health insurance exchanges,
both a criminal background and
fingerprint check and has a clean
record free of criminal infractions;
and
''(II) meets educational and
licensure requirements that are
identical or comparable to those
currently applicable to health
insurance agents and brokers within the
State they seek to assist consumers
with health insurance enrollment.
''(iii) Requirement for prior certification
of safeguards.--The recipient of the grant may
not collect personally identifiable information
for any reason until the Comptroller General of
the United States, in agreement with the
Inspector General of the Department of Health
and Human Services, certifies to Congress that
such Department, along with any other relevant
Federal agencies involved with health insurance
assistance or enrollment, or collection or
verification of personally identifiable
information, have implemented all appropriate
and necessary actions to safeguard both the
such information and financial information of
individuals seeking enrollment in a health plan
through an Exchange and to protect such
individuals from fraud and abuse.
''(C) Liability.--Not later than 90 days after the
date of the enactment of this paragraph, the
Secretary--
''(i) shall issue guidance concerning how
liability and penalties will be applied in
instances of failure to comply with
requirements of this paragraph, including where
consumer outreach and enrollment assistance
causes harm to an individual as a result of
misuse or negligence in protection and privacy
of personally identifiable information;
''(ii) shall determine whether such
liability lies with the person (such as a
navigator, certified application counselor, or
non-navigator assistance personnel) having
direct contact with the prospective enrollee in
enrollment assistance-related actions or
whether liability lies with the entity that
received Federal or Exchange-generated funds to
carry out consumer outreach activities; and
''(iii) shall determine whether the
entities identified under clause (ii) are
required to obtain professional liability
coverage.
''(D) Penalties.--
''(i) Criminal penalties.--
''(I) Any individual or entity who,
under this section, has possession of,
or access to, personally identifiable
information the disclosure of which is
prohibited by this section (or section
552a of title 5, United States Code) or
by rules or regulations established
thereunder, and who knowing that
disclosure of the specific material is
so prohibited, willfully discloses the
material in any manner to any person or
entity not entitled to receive it,
shall be guilty of a misdemeanor and
fined not more than $5,000.
''(II) A person who commits the
offense described under subclause (I)
with the intent to sell, transfer, or
use personally identifiable information
for commercial advantage, personal
gain, or malicious harm shall be fined
not more than $250,000, imprisoned for
not more than 10 years, or both.
''(III) Any person who knowingly
and willfully requests or obtains any
personally identifiable information
protected under this section concerning
an individual under false pretenses
shall be guilty of a felony and fined
not more than $100,000, imprisoned for
not more than 5 years, or both.
''(ii) Potential exposure to tax penalty.--
Any navigator, certified application counselor,
or non-navigator assistance personnel who
engages in health plan enrollment consumer
assistance activities under this section and
who is exposed to consumer tax return
information is potentially subject to criminal
liability under section 7213(a) of the Internal
Revenue Code of 1986 for any instances of
unauthorized disclosure of such information.
''(iii) Disqualification from further
assistance.--If the Secretary determines that
any individual, including any navigator,
certified application counselor, or non-
navigator assistance personnel, has a criminal
background or is otherwise in violation of this
paragraph with respect to the requirements
relating to disclosure and use of personally
identifiable information, the Secretary shall
permanently disqualify the individual from any
further involvement in consumer assistance
activities required under this section or the
Patient Protection and Affordable Care Act and
may disqualify and rescind the Federal and
Exchange-generated funds from the entity which
employs or contracts with such an individual.
''(E) Consumer opt out for lack of privacy
protection.--Beginning on the date of health insurance
exchange operations for both individuals and
businesses, no individual consumer shall be made
responsible for failure to meet a requirement under the
Patient Protection and Affordable Care Act (including
any amendments made by this Act) for obtaining
qualified health insurance coverage through an Exchange
unless the Secretary has demonstrated with reasonable
certainty that effective and comprehensive protection
of personally identifiable information, with respect to
any health insurance enrollment activity electronic or
otherwise, are in place prior to any consumer
disclosure or transmission of personally identifiable
information for health insurance enrollment purposes.
''(F) Personally identifiable information
defined.--In this paragraph, the term 'personally
identifiable information' includes Social Security
numbers, bank account information, insurance records,
health records, personal income data, and any other
information deemed personally identifiable and
sensitive in nature by the Federal Trade Commission,
the Department of Justice, the Social Security
Administration, the Consumer Financial Protection
Bureau, the President's Task Force on Identity Theft,
and any other relevant Federal agency, which is
disclosed or obtained in connection with any health
insurance enrollment activity conducted under this
section.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect on the date of the enactment of this Act and shall apply to
grants made before, on, or after the date of the enactment of this Act.
The Secretary of Health and Human Services shall provide for the prompt
modification of such grants made before the date of the enactment of
this Act in order to comply with the requirement imposed by such
amendment.

Ex Output:
Security Before Access Act of 2013 - Amends the Public Health Service Act, with respect to patient navigator services, to require recipients of grants for the development and operation of demonstration programs to implement procedures developed under this Act to protect the privacy of personally identifiable information (PII). Requires procedures specified by the Secretary of Health and Human Services (HHS) to include at least those that: require for access to PII relating to an individual the express written consent of that individual; condition access by a certified application counselor, health insurance navigator, or non-navigator assistance personnel upon a criminal background and fingerprint check; and require the meeting of educational and licensure requirements that are identical or comparable to those currently applicable to health insurance agents and brokers within the state in which they seek to assist consumers. Prohibits a grant recipient from collecting PII until the Comptroller General (GAO) certifies to Congress that HHS and any other relevant federal agencies have implemented all appropriate and necessary actions to safeguard the information of individuals seeking enrollment in a health plan through a health insurance Exchange and to protect them from fraud and abuse. Provides procedures for development of guidance concerning liability, determinations of liable parties, and determinations of whether entities described in this Act are required to obtain professional liability coverage. Imposes criminal penalties for unauthorized access, including under the Internal Revenue Code in cases involving consumer tax return information. Requires the Secretary to permanently disqualify an individual with a criminal background or otherwise in violation of this Act from any further involvement in consumer assistance activities required under the patient navigator provisions or the Patient Protection and Affordable Care Act (PPACA). Allows the disqualification and rescission of federal and Exchange-generated funds from the entity that employs or contracts with such an individual. Relieves consumers from responsibility for failure to meet a requirement under PPACA for obtaining qualified health insurance coverage through an Exchange unless the Secretary has demonstrated with reasonable certainty that effective and comprehensive PII protection is in place prior to any consumer disclosure for health insurance enrollment purposes.