type: legislation

text:
 II
 111th CONGRESS
 1st Session
 S. 726
 IN THE SENATE OF THE UNITED STATES
 March 26, 2009
 Mr. Schumer (for
 himself, Ms. Collins,
 Mr. Brown, Mr.
 Vitter, Ms. Stabenow,
 Mr. Martinez, and
 Mrs. Shaheen) introduced the following
 bill; which was read twice and referred to the
 Committee on Health, Education, Labor,
 and Pensions
 A BILL
 To amend the Public Health Service Act to provide for the
 licensing of biosimilar and biogeneric biological products, and for other
 purposes.
 1.Short titleThis Act may be cited as the
 Promoting Innovation and Access to
 Life-Saving Medicine Act.
 2.Definitions
 (a)LicensureSection 351(i) of the Public Health Service
 Act (42 U.S.C. 262(i)) is amended—
 (1)by striking
 In this section, the term biological product means
 and inserting the following:
 In this
 section:(1)The term
 biological product means
 ;
 and
 (2)by adding at the
 end the following:
 (2)The term abbreviated biological
 product application means an abbreviated application for a license of a
 biological product that relies in part on data or information in an application
 for another biological product licensed under this section or approved under
 section 505 of the Federal Food, Drug, and Cosmetic Act.
 (3)The term
 reference product means the single licensed biological product,
 approved under subsection (a) or (k), against which a biological product is
 evaluated for demonstration of safety, potency, or purity.
 (4)The term final action means,
 with respect to an abbreviated biological product application, the Secretary’s
 issuance of a final action letter to the sponsor of an abbreviated biological
 product application which—
 (A)approves the
 application; or
 (B)disapproves the
 application and sets forth in detail an enumeration of the specific
 deficiencies in the particular application and of the specific, enumerated
 actions the sponsor would be required to take in order for the sponsor to
 receive a final action letter that approves such application.
 (5)The term final action date
 means, with respect to an abbreviated biological product application, the date
 by which the Secretary must take a final action on the application pursuant to
 subsection (k)(13).
 (6)The term
 reviewing division means the division responsible for the review
 of an application for approval of a biological product (including all
 scientific and medical matters, chemistry, manufacturing, and
 controls).
 .
 (b)Fees
 (1)Rule of
 constructionThe definition of a human drug application in
 section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1))
 shall be construed to include applications under section 351(k) of the Public
 Health Service Act, as added by section 3, in addition to applications under
 section 351(a) of such Act.
 (2)SupplementSection
 735(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(2)) is
 amended by adding at the end the following: Notwithstanding the
 preceding sentence, any request for an interchangeability determination under
 section 351(k) of the Public Health Service Act shall be treated as a
 supplement for purposes of this part, irrespective of whether such request is
 included in an application for licensure of a biological product or a
 subsequent submission..
 3.Regulation of
 biosimilar and biogeneric biological products
 (a)In
 generalSection 351 of the Public Health Service Act (42 U.S.C.
 262), as amended by section 2, is further amended—
 (1)in subsection
 (a)(1)(A), by inserting under this subsection or subsection (k)
 after biologics license; and
 (2)by adding at the
 end the following subsection:
 (k)Regulation of
 biosimilar and interchangeable biological products
 (1)BiosimilarIn
 this subsection, the term biosimilar or
 biosimilarity, in reference to a biological product, means no
 clinically meaningful differences between the biological product and the
 reference product would be expected in terms of the safety, purity, and potency
 if treatment were to be initiated with the biological product instead of the
 reference product.
 (2)InterchangeabilityIn
 this subsection, the term interchangeable or
 interchangeability means, with respect to a given condition of
 use, that—
 (A)the biological
 product is biosimilar to the reference product; and
 (B)if the biological
 product is intended to be administered more than once to a given patient, the
 patient can be switched one or more times between the reference product and the
 biological product without an expected increase in the risk of adverse effects,
 including a clinically significant change in immunogenicity, or
 diminished effectiveness, compared to the expected risks from continuing to use
 the reference product without such switching.
 (3)Submission of an
 abbreviated biological product applicationAny person may file
 with the Secretary an abbreviated biological product application. Any such
 application shall include the following:
 (A)Information
 demonstrating that the biological product and reference product contain highly
 similar molecular structural features, notwithstanding minor differences in
 heterogeneity profile, impurities, or degradation patterns.
 (B)Information
 demonstrating that the biological product is biosimilar to (as defined in
 paragraph (1)) or interchangeable with (as defined in paragraph (2)) the
 reference product for the condition or conditions of use prescribed,
 recommended, or suggested in the proposed labeling based upon, in the
 discretion of the Secretary—
 (i)information
 derived from chemical, physical, and biological assays, and other non-clinical
 laboratory studies; and
 (ii)information from
 any necessary clinical study or studies sufficient to confirm safety, purity,
 and potency.
 Any
 studies under clause (ii) shall be designed to avoid duplicative and unethical
 clinical testing.(C)Information
 demonstrating that the biological product and reference product utilize the
 same mechanism or mechanisms of action for the condition or conditions of use
 prescribed, recommended, or suggested in the proposed labeling, but only to the
 extent the mechanism or mechanisms of action are known for the reference
 product or can reasonably be determined. If the applicant seeks to rely on a
 demonstration of biosimilarity or interchangeability for a single condition of
 use to support approval of additional conditions of use that share the same
 mechanism or mechanisms of action, information demonstrating that such reliance
 is scientifically appropriate.
 (D)Information to
 show that the condition or conditions of use prescribed, recommended, or
 suggested in the proposed labeling for the biological product have been
 previously approved for the reference product.
 (E)Information to
 show that the route of administration, the dosage form, and the strength of the
 biological product are the same as those of the reference product.
 (F)Information
 demonstrating that the facility in which the biological product is
 manufactured, processed, packed, or held meets standards designed to ensure
 that the biological product continues to be safe, pure, and potent.
 (4)Other
 applicationsAny person, including a person who has not conducted
 and does not have a right of reference to the studies in the application for a
 reference product, may submit an abbreviated biological product application
 under this paragraph for a biological product that differs from, or
 incorporates a change to, the reference product with respect to one or more
 characteristics described in subparagraphs (A) through (E) of paragraph (3),
 including a difference in safety, purity, or potency, so long as the
 application contains sufficient information to establish the safety, purity,
 and potency of the biological product for its proposed condition or conditions
 of use.
 (5)Approval of
 biosimilar or interchangeable biological products
 (A)Determination of
 biosimilarityUpon review of an application submitted under
 paragraph (3) for a biological product and any other information available to
 the Secretary, including information in the application for the reference
 product, the Secretary shall issue a biosimilar biological product license for
 the conditions of use prescribed, recommended, or suggested in the proposed
 labeling for the product, unless the Secretary finds and informs the applicant
 (including provision of a detailed explanation) that—
 (i)information
 submitted in the application and any other information available to the
 Secretary is insufficient to show that the biological product and the reference
 product contain highly similar molecular structural features, notwithstanding
 minor differences in heterogeneity profile, impurities, or degradation
 patterns;
 (ii)information
 submitted in the application and any other information available to the
 Secretary is insufficient to show that the biological product is biosimilar to
 the reference product for the condition or conditions of use prescribed,
 recommended, or suggested in the labeling proposed in the application;
 (iii)information
 submitted in the application and any other information available to the
 Secretary is insufficient to show that the biological product and reference
 product utilize the same mechanism or mechanisms of action for the conditions
 of use prescribed, recommended, or suggested in the proposed labeling for the
 biological product, unless the mechanism or mechanisms of action are not known
 and cannot reasonably be determined for the reference product for such
 condition or conditions;
 (iv)if the applicant
 has demonstrated biosimilarity for a single condition of use sharing the same
 mechanism of action as other conditions of use of the reference product, and
 has sought approval of one or more such other conditions of use on the basis of
 such demonstration, information submitted in the application and any other
 information available to the Secretary is insufficient to show the safety,
 purity, and potency of one or more such other conditions of use;
 (v)information
 submitted in the application and any other information available to the
 Secretary is insufficient to show that the route of administration, the dosage
 form, and the strength of the biological product are the same as those of the
 reference product;
 (vi)information
 submitted in the application and any other information available to the
 Secretary is insufficient to show that the condition or conditions of use
 prescribed, recommended, or suggested in the proposed labeling for the
 biological product are limited to one or more of the same use or uses as have
 been previously approved for the reference product;
 (vii)information
 submitted in the application and any other information available to the
 Secretary shows (I) the inactive ingredients of the biological product are
 unsafe for use under the conditions prescribed, recommended, or suggested in
 the proposed labeling for the biological product, or (II) the composition of
 the biological product is unsafe under such conditions because of the type or
 quantity of inactive ingredients included or the manner in which the inactive
 ingredients are included;
 (viii)information
 submitted in the application and any other information available to the
 Secretary fails to demonstrate that the facility in which the biological
 product is manufactured, processed, packed, or held meets standards designed to
 ensure that the biological product continues to be safe, pure, and
 potent;
 (ix)the Secretary
 has, for reasons of safety, purity, or potency, other than reasons that are
 unique to the reference product—
 (I)withdrawn or
 suspended the license of the reference product;
 (II)published a
 notice of opportunity for hearing to withdraw such license; or
 (III)determined that
 the reference product has been withdrawn from sale; or
 (x)the application
 contains an untrue statement of material fact.
 (B)Determinations
 on interchangeabilitySubject to subparagraph (C) and paragraph
 (11), upon issuing a product license for a biological product under
 subparagraph (A), the Secretary shall make and publish one of the following
 determinations:
 (i)Such product is
 interchangeable with the reference product for one or more specified conditions
 of use prescribed, recommended, or suggested in the labeling of the biological
 product.
 (ii)Interchangeability
 has not been established, but the approved product is as safe and effective for
 its approved uses as the reference product.
 (C)Determination of
 interchangeability of subsequent biological productIf the
 Secretary determines that an application meets the approval requirements of
 subparagraph (A), and, prior to the issuance of a product license, the
 Secretary has made a determination of interchangeability of another biological
 product and the reference product for which the exclusivity period under
 paragraph (11) has not expired, the Secretary shall—
 (i)issue the product
 license for the subsequent biological product; and
 (ii)defer issuing any
 determination of interchangeability as to the subsequent biological product and
 the reference product until the exclusivity period under paragraph (11) has
 expired.
 (6)Designation of
 official name
 (A)In
 generalIf, pursuant to section 508 of the Federal Food, Drug,
 and Cosmetic Act, the Secretary determines that designation of an official name
 for a biosimilar biological product is necessary or desirable in the interests
 of usefulness or simplicity, the Secretary shall designate the same official
 name for the biosimilar biological product as the Secretary designated for the
 reference product.
 (B)LimitationThis
 paragraph shall not apply to products approved under paragraph (7).
 (C)Report to
 CongressNot later than 5
 years after the date of the enactment of this subsection, the Comptroller
 General of the United States shall submit a report to the Congress on public
 health and economic impacts associated with practices for designating the
 official names of biosimilar biological products in the United States and in
 other countries that approve biosimilar biological products.
 (7)Other approval
 provisionsThe Secretary shall approve an application for a
 license submitted under paragraph (4) if the application and any other
 information available to the Secretary, including information in the
 application for the reference product, are sufficient to establish the safety,
 purity, and potency of the biosimilar biological product for the proposed
 condition or conditions of use for such product.
 (8)Establishing
 interchangeability for biosimilar biological products
 (A)In
 generalIn an original application or a supplement to an
 application under this subsection, an applicant may submit information to the
 Secretary to demonstrate the interchangeability of a biosimilar biological
 product and the reference product. An applicant may withdraw a request for an
 interchangeability determination at any time. A request for an
 interchangeability determination submitted after the filing of an application
 shall be considered a major amendment to the application. Except as provided in
 paragraph (11), nothing in this subsection shall be construed to prohibit the
 Secretary from making a determination of interchangeability at any time after
 approval.
 (B)GuidanceWithin
 2 years after enactment of this subsection, the Secretary shall issue guidance
 regarding standards and requirements for interchangeability. The Secretary is
 authorized to make determinations of interchangeability under paragraph (5)(B)
 prior to issuing guidance under this subparagraph.
 (9)Interchangeability
 labeling for interchangeable biological productsExcept as
 provided in paragraph (11), upon a determination of interchangeability, the
 Secretary shall, at the request of the applicant, provide for the label of the
 interchangeable biological product to include a statement that the biological
 product is interchangeable with the reference product for the conditions of use
 prescribed, recommended, or suggested in the labeling for which
 interchangeability has been established.
 (10)Delay of
 approval
 (A)Applicable delay
 period
 (i)5-year
 periodIf an application under this subsection refers to a
 biological product described in clause (i) of subparagraph (B), the Secretary
 may not approve such application before the expiration of—
 (I)the 5-year period
 beginning on such product’s approval date; or
 (II)such period, as
 extended under subparagraph (D).
 (ii)3-year
 periodIf an application under this subsection refers to a
 biological product described in subparagraph (C), the Secretary may not approve
 such application for the conditions of approval of such product before the
 expiration of—
 (I)the 3-year period
 beginning on such product’s approval date; or
 (II)such period, as
 extended under subparagraph (D).
 (B)No major
 substance previously approved
 (i)In
 generalA biological product is described in this clause
 if—
 (I)an application is
 submitted for such product under subsection (a);
 (II)no major
 substance of the product, nor any highly similar major substance, has been
 approved in any other application under subsection (a);
 (III)the application
 submitted for such product is approved after the date of the enactment of this
 subsection; and
 (IV)the application
 submitted for such product could not and did not rely on any clinical safety,
 purity, or potency study in any other application approved under this section
 or any clinical safety or effectiveness study in any application approved under
 section 505 of the Federal Food, Drug, and Cosmetic Act.
 (ii)ExclusionsBiological
 products not described in clause (i) include the following:
 (I)Protein biological
 products that differ in structure solely due to post-translational events,
 infidelity of translation or transcription, or minor differences in amino acid
 sequence.
 (II)Polysaccharide
 biological products with similar saccharide repeating units, even if the number
 of units differ and even if there are differences in post-polymerization
 modifications.
 (III)Glycosylated
 protein products that differ in structure solely due to post-translational
 events, infidelity of translation or transcription, or minor differences in
 amino acid sequence, and if they had similar saccharide repeating units, even
 if the number of units differ and even if there were differences in
 post-polymerization modifications.
 (IV)Polynucleotide
 biological products with identical sequence of purine and pyrimidine bases (or
 their derivatives) bound to an identical sugar backbone (ribose, deoxyribose,
 or modifications of these sugars).
 (V)Closely related,
 complex partly definable biological products with similar therapeutic intent,
 such as live viral products for the same indication.
 The Secretary
 may by regulation identify additional biological products not described in
 clause (i).(C)Major substance
 previously approvedA biological product is described in this
 subparagraph if—
 (i)an
 application is submitted for such product under subsection (a);
 (ii)such product
 includes a major substance that has been approved in another application under
 subsection (a), or any highly similar major substance;
 (iii)the application
 submitted for such product is approved after the date of the enactment of this
 subsection;
 (iv)the application
 submitted for such product contains reports of new clinical investigations
 (other than pharmacokinetic or pharmacodynamic studies) essential to the
 approval of the application and conducted or sponsored by the applicant;
 and
 (v)the product
 represents a significant therapeutic advance, which may include demonstration
 of safety, purity, and potency for a significant new indication or
 subpopulation, other than a pediatric subpopulation.
 (D)(i)SupplementIf
 a supplement to an application approved under subsection (a) is approved no
 later than 1 year before the expiration of a period to which the applicant is
 entitled under subparagraph (A), the period described in subparagraph (A)
 shall, except as provided in clause (ii), be extended by 6 months if—
 (I)the supplement contains reports of new
 clinical investigations (other than pharmacokinetic or pharmacodynamic studies)
 essential to the approval of the supplement and conducted or sponsored by the
 person submitting the supplement; and
 (II)the change provides a significant
 therapeutic advance, which may include demonstration of safety, purity, and
 potency for a significant new indication or subpopulation, other than a
 pediatric subpopulation.
 (ii)AdjustmentAny
 period of market exclusivity extended under subclause (I) or (II) of clause (i)
 for a biological product shall be reduced by 3 months if the organization
 designated under subparagraph (E) notifies the Secretary that, with respect to
 any major substance contained in the biological product, the combined annual
 gross sales in the United States for all biological products—
 (I)containing the major substance;
 and
 (II)owned or marketed by the applicant or
 its affiliates;
 exceeded
 $1,000,000,000 in the calendar year preceding approval of the supplement
 involved.(iii)LimitationOnly
 one extension under this subparagraph may be granted for any biological
 product.
 (E)(i)DesignationThe Secretary shall designate an
 organization other than the Food and Drug Administration to make the
 determination of combined annual gross sales described in clause (ii). Prior to
 designating such organization, the Secretary shall determine that such
 organization is independent and is qualified to evaluate the sales of
 pharmaceutical products. The Secretary shall re-evaluate the designation of
 such organization once every 3 years.
 (ii)NotificationThe
 organization designated under clause (i) shall—
 (I)determine, with respect to each major
 substance contained in each biological product that is the subject of a pending
 supplement under subparagraph (D)(i), the amount of the combined annual gross
 sales in the United States in the preceding calendar year for all biological
 products—
 (aa)containing the major substance;
 and
 (bb)owned or marketed by the applicant or
 its affiliates; and
 (II)notify the Secretary of such
 determination.
 (F)DefinitionIn
 this paragraph, the term approval date means the date of approval
 of an application for the biological product under subsection (a).
 (11)Exclusivity
 (A)In
 generalUpon review of an abbreviated biological product
 application relying on the same reference product for which a prior biological
 product has received a determination of interchangeability for any condition of
 use, the Secretary shall not make a determination under paragraph (5)(B) that
 the second or subsequent biological product is interchangeable for any
 condition of use, and no holder of a biological product license approved under
 subsection (a) shall manufacture, market, sell, or distribute a rebranded
 interchangeable biological product, directly or indirectly, or authorize any
 other person to manufacture, market, sell, or distribute a rebranded
 interchangeable biological product, for any condition of use, until the earlier
 of—
 (i)180 days after the
 first commercial marketing of the first interchangeable biological product to
 be approved as interchangeable for that reference product;
 (ii)one year
 after—
 (I)a final court
 decision in favor of the applicant on all patents in suit in an action
 instituted under paragraph (18)(C) against the applicant that submitted the
 application for the first approved interchangeable biological product;
 or
 (II)the dismissal
 with or without prejudice of an action instituted under paragraph (18)(C)
 against the applicant that submitted the application for the first approved
 interchangeable biological product; or
 (iii)(I)36 months after approval
 of the first interchangeable biological product if the applicant has been sued
 under paragraph (18)(C) and such litigation is still ongoing within such
 36-month period; or
 (II)one year after approval in the event
 that the first approved interchangeable biological product applicant has not
 been sued under paragraph (18)(C).
 For
 purposes of this subparagraph, the term final court decision means
 a final decision of a court from which no appeal (other than a petition to the
 United States Supreme Court for a writ of certiorari) has been or can be
 taken.(B)Rebranded
 interchangeable biological productFor purposes of this
 subsection, the term rebranded interchangeable biological
 product—
 (i)means any
 rebranded interchangeable version of the reference product involved that the
 holder of the biological product license approved under subsection (a) for that
 reference product seeks to commence marketing, selling, or distributing,
 directly or indirectly; and
 (ii)does not include
 any product to be marketed, sold, or distributed—
 (I)by an entity
 eligible for exclusivity with respect to such product under this paragraph;
 or
 (II)after expiration
 of any exclusivity with respect to such product under this paragraph.
 (12)HearingIf
 the Secretary decides to disapprove an abbreviated biological product
 application, the Secretary shall give the applicant notice of an opportunity
 for a hearing before the Secretary on the question of whether such application
 is approvable. If the applicant elects to accept the opportunity for hearing by
 written request within 30 days after such notice, such hearing shall commence
 not more than 90 days after the expiration of such 30 days unless the Secretary
 and the applicant otherwise agree. Any such hearing shall thereafter be
 conducted on an expedited basis, and the Secretary’s order thereon shall be
 issued within 90 days after the date fixed by the Secretary for filing final
 briefs.
 (13)Final action
 date
 (A)In
 generalThe Secretary shall take a final action on an abbreviated
 biological product application by the date that is 10 calendar months following
 the sponsor’s submission of such application, or 180 days following the
 Secretary’s notification to the applicant that its application has been
 accepted for filing, whichever is earlier.
 (B)ExtensionThe
 final action date provided by subparagraph (A) with respect to an application
 may be extended for such period of time as is agreed to by the Secretary and
 the applicant in a jointly executed written agreement that is counter-signed by
 the Secretary and the applicant no later than 30 days prior to—
 (i)such final action
 date; or
 (ii)the date on which
 any prior extension under this subparagraph expires.
 (14)Request for
 delay of final actionSubject to paragraph (19)(A)(i) and
 notwithstanding any other provision of law, the Secretary shall not fail or
 refuse to take a final action on an abbreviated biological product application
 by the final action date on the basis that a person, other than the biosimilar
 biological product applicant, has requested (in a petition or otherwise) that
 the Secretary refuse to take or otherwise defer such final action, and no court
 shall enjoin the Secretary from taking final action or stay the effect of final
 action previously taken by the Secretary, except by issuance of a permanent
 injunction based upon an express finding of clear and convincing evidence that
 the person seeking to have the Secretary refuse to take or otherwise to defer
 final action by the final action date—
 (A)has prevailed on
 the merits of the person’s complaint against the Secretary;
 (B)will suffer
 imminent and actual irreparable injury, constituting more than irrecoverable
 economic loss, and that also will threaten imminent destruction of such
 person’s business; and
 (C)has an interest
 that outweighs the overwhelming interest that the public has in obtaining
 prompt access to a biosimilar biological product.
 (15)Report on
 extensions of final action dateThe Secretary shall prepare and
 submit to the President, the Committee on Energy and Commerce of the House of
 Representatives, and the Committee on Health, Education, Labor, and Pensions of
 the Senate a report regarding any jointly executed written agreement to extend
 the final action date under this Act within 15 calendar days after the joint
 execution of any such written agreement.
 (16)Report on
 failure to take final actionThe Secretary shall prepare and
 submit annually to the President, the Committee on Energy and Commerce of the
 House of Representatives, and the Committee on Health, Education, Labor, and
 Pensions of the Senate a report detailing the specific and particularized
 reasons enumerated by the reviewing division for each instance of the
 Secretary’s failure to take final action by the final action date in the
 previous year.
 (17)RegulationsThe
 Secretary shall establish, by regulation within 2 years after the date of the
 enactment of this subsection, requirements for the efficient review, approval,
 suspension, and revocation of abbreviated biological product applications under
 this subsection. The Secretary may not use the absence of final regulations as
 a basis for the Secretary to fail to act on an application submitted under this
 subsection.
 (18)Patents
 (A)Request for
 patent information
 (i)In
 generalAt any time, including at the initial stages of
 development, an applicant or a prospective applicant under this subsection may
 send a written request for patent information to the holder of the approved
 application for the reference product. The holder of the approved application
 for the reference product shall, not later than 60 days after the date on which
 the holder receives the request, provide to the applicant or prospective
 applicant a list of all those patents owned by, licensed to, or otherwise under
 the control of, the holder of the approved application that the holder believes
 in good faith relate to the reference product, including patents that claim the
 approved biological product, any formulation of such product, any method of
 using such product, any component of such product, or any method or process
 that can be used to manufacture such product or component, regardless of
 whether that method or process is used to manufacture the reference
 product.
 (ii)UpdatesFor
 a period of 2 years beginning on the date on which the holder of the approved
 application for the reference product receives the request for information, the
 holder shall send to the applicant or prospective applicant updates of its
 response to the request for information by identifying all relevant patents
 issued or licensed to the holder after the initial response under clause (i).
 Any such update must be provided, in the case of a new patent, not later than
 30 days after the date on which the patent is issued and, in the case of a
 license, not later than 30 days after the date on which the holder obtains the
 license.
 (iii)Additional
 requestsThe applicant may submit additional requests under
 clause (i) for patent information, and each such request shall be subject to
 the requirements of this paragraph.
 (iv)Notification to
 patent holderWithin 30 days of receiving a request under this
 subparagraph, the holder of the approved application for the reference product
 shall give notice of such request to the owner of any patent licensed to, or
 otherwise under the control of, the holder that is identified by the holder
 pursuant to clause (i).
 (B)Patent
 notificationsAt any time after submitting an application under
 this subsection, the applicant may provide a notice of the application with
 respect to any one or more patents identified by the holder of the reference
 product pursuant to subparagraph (A) or with respect to any one or more patents
 owned by, licensed to, or otherwise under the control of the holder of the
 approved application, but not identified pursuant to subparagraph (A). An
 applicant may submit additional notices at any time, and each notice shall be
 subject to the provisions of this subparagraph. Each notice shall—
 (i)be
 sent to the holder of the approved application for the reference product and to
 the owner of any patent identified by the holder pursuant to subparagraph
 (A);
 (ii)include a
 detailed statement of the factual and legal bases for the applicant’s belief
 that the patents included in the notice are invalid, are unenforceable, or will
 not be infringed by the commercial sale of the product for which approval is
 being sought under this subsection; and
 (iii)be submitted to
 the Federal Trade Commission, which shall treat such notice as
 confidential.
 (C)Action for
 infringementWithin 45 days after the date on which the holder of
 the approved application for the reference product, or the owner of a patent,
 receives a notice under subparagraph (B), the holder or patent owner may bring
 an action for infringement only with respect to the patent or patents included
 in the notice.
 (D)Limitation on
 declaratory judgment actionsWith respect to any patent relating
 to a product that is the subject of an application under this subsection, the
 recipient of a notice under subparagraph (B) with respect to that application
 may not, prior to the commercial marketing of the product, bring any action
 under section 2201 of title 28, United States Code, for a declaration of
 infringement, validity, or enforceability of any such patent that was not
 identified in the notice.
 (E)Declaratory
 judgment action
 (i)In
 generalWith respect to any patent identified in a notification
 under subparagraph (A) or (B) for which the holder, or the owner of the
 patent—
 (I)has not brought an
 action for infringement under subparagraph (C); or
 (II)has brought an
 action for infringement under subparagraph (C), but subsequently dismissed that
 action without prejudice;
 the applicant
 may bring an action for a declaratory judgment under section 2201 of title 28,
 United States Code, that such patent is invalid or not infringed by the
 biological product at issue.(ii)Case or
 controversyThe courts of the United States shall have, and shall
 exercise, subject matter jurisdiction to hear such an action to the full extent
 permitted by article III of the Constitution.
 (F)Discretion of
 applicantsAn applicant or prospective applicant for a biosimilar
 biological product under this subsection may not be compelled, by court order
 or otherwise, to initiate the procedures set forth in this paragraph. Nothing
 in this paragraph requires an applicant or a prospective applicant to invoke
 the procedures set forth in this paragraph.
 (19)Petitions and
 civil actions regarding approval of certain applications
 (A)In
 generalWith respect to a pending application submitted under
 paragraph (3) or (4), if a petition is submitted to the Secretary that seeks to
 have the Secretary take, or refrain from taking, any form of action relating to
 the approval of the application, including a delay in the effective date of the
 application, the following applies, subject to subparagraph (E):
 (i)(I)The Secretary may not,
 on the basis of the petition, delay approval of the application unless the
 Secretary determines, within 30 days after receiving the petition, that a delay
 is necessary to protect the public health. Consideration of a petition shall be
 separate and apart from the review and approval of the application.
 (II)With respect to a determination by the
 Secretary under subclause (I) that a delay is necessary to protect the public
 health:
 (aa)The Secretary shall publish on the
 Internet site of the Food and Drug Administration a statement providing the
 reasons underlying the determination.
 (bb)Not later than 10 days after making
 the determination, the Secretary shall provide notice to the sponsor of the
 application and an opportunity for a meeting with the Commissioner to discuss
 the determination.
 (ii)The Secretary
 shall take final agency action on the petition not later than 180 days after
 the date on which the petition is submitted. The Secretary shall not extend
 such period, even with the consent of the petitioner, for any reason, including
 based upon the submission of comments relating to the petition or supplemental
 information supplied by the petitioner.
 (iii)The Secretary
 may not consider the petition for review unless it is signed and contains the
 following verification: I certify that, to my best knowledge and belief:
 (a) this petition includes all information and views upon which the petition
 relies; (b) this petition includes representative data and/or information known
 to the petitioner which are unfavorable to the petition; and (c) I have taken
 reasonable steps to ensure that any representative data and/or information
 which are unfavorable to the petition were disclosed to me. I further certify
 that the information upon which I have based the action requested herein first
 became known to the party on whose behalf this petition is submitted on or
 about the following date: [___]. I received or expect to receive payments,
 including cash and other forms of consideration, from the following persons or
 organizations to file this petition: [___]. I verify under penalty of perjury
 that the foregoing is true and correct..
 (B)Denial based on
 intent to delayIf the Secretary determines that a petition or
 supplement to the petition was submitted with the primary purpose of delaying
 the licensure or the approval of a condition of use for a biological product,
 the Secretary may deny the petition at any point based on such determination.
 The Secretary may issue guidance to describe the factors that will be used to
 determine under this subparagraph whether a petition is submitted with the
 primary purpose of delaying the approval of an application.
 (C)Exhaustion of
 administrative remedies
 (i)Final agency
 action within 180 daysThe Secretary shall be considered to have
 taken final agency action on a petition referred to in subparagraph (A)
 if—
 (I)during the 180-day
 period referred to in clause (ii) of such subparagraph, the Secretary makes a
 final decision within the meaning of section 10.45(d) of title 21, Code of
 Federal Regulations (or any successor regulations); or
 (II)such period
 expires without the Secretary having made such a final decision, in which case
 the petition shall be deemed to have been denied.
 (ii)Dismissal of
 certain civil actionsIf a civil action is filed with respect to
 a petition referred to in subparagraph (A) before final agency action within
 the meaning of clause (i) has occurred, the court shall dismiss the action for
 failure to exhaust administrative remedies.
 (D)Applicability of
 certain regulationsThe provisions of this section are in
 addition to the requirements for the submission of a petition to the Secretary
 that apply under section 10.30 or 10.35 of title 21, Code of Federal
 Regulations (or any successor regulations).
 (E)Annual report on
 delays in approvals per petitionsThe Secretary shall annually
 submit to the Congress a report that specifies—
 (i)the number of
 applications under this subsection that were approved during the preceding
 12-month period;
 (ii)the number of
 such applications whose effective dates were delayed by petitions referred to
 in subparagraph (A) during such period; and
 (iii)the number of
 days by which the applications were so delayed.
 (F)ExceptionThis
 paragraph does not apply to a petition that is made by the sponsor of an
 application under this subsection and that seeks only to have the Secretary
 take or refrain from taking any form of action with respect to that
 application.
 (G)DefinitionFor
 purposes of this paragraph, the term petition includes any request
 to the Secretary, without regard to whether the request is characterized as a
 petition.
 (20)Authorization
 of appropriationsTo carry out this subsection, there are
 authorized to be appropriated such sums as may be necessary for fiscal years
 2010 and
 2011.
 .
 (b)Additional
 amendments
 (1)VenueSection
 1404 of title 28, United States Code, is amended by adding at the end the
 following:
 (e)Venue in certain
 patent infringement disputes
 (1)In
 generalIn any action for patent infringement brought by the
 holder or owner of the patent pursuant to section 351(k)(18)(C) of the Public
 Health Service Act, the defendant may move to transfer the action to any other
 district in which jurisdiction is proper.
 (2)TimingThe
 schedule applicable to a motion under paragraph (1) is as follows:
 (A)A motion under
 paragraph (1) shall be filed by the defendant no later than 45 days after
 service of the complaint.
 (B)A response to such
 a motion, if any, shall be filed no later than 20 days after service of the
 motion.
 (C)A reply to such
 response, if any, shall be filed no later than 10 days after service of the
 response.
 (D)The schedule set
 forth in this paragraph may be modified only by agreement of all
 parties.
 (3)ResolutionWhen
 ruling on any motion filed under paragraph (2), the greatest weight shall be
 given to the following factors:
 (A)The interest in
 identifying a district court in which the case will be adjudicated
 expeditiously.
 (B)The strong public
 interest in obtaining prompt judicial resolution of patent disputes so that the
 biological product which is the subject of the patent dispute may be brought to
 market as expeditiously as possible, consistent with fair and prompt resolution
 of patent disputes.
 (4)No
 delayAn action described in paragraph (1) shall proceed as
 expeditiously as possible while the court considers a motion under this
 subsection, and the court may not stay the proceedings because a motion under
 this subsection has been
 filed.
 .
 (2)PatentsSection
 271(e) of title 35, United States Code, is amended—
 (A)in paragraph
 (2)—
 (i)by
 striking or at the end of subparagraph (A);
 (ii)by
 adding or at the end of subparagraph (B);
 (iii)by
 inserting after subparagraph (B) the following:
 (C)a notice described
 in section 351(k)(18)(B) of the Public Health Service Act, but only with
 respect to a patent identified in such
 notice,
 ;
 and
 (iv)in
 the matter following subparagraph (C) (as inserted by clause (iii) of this
 subparagraph), by inserting before the period the following: , or if the
 notice described in subparagraph (C) is provided in connection with an
 application to obtain a license to engage in the commercial manufacture, use,
 or sale of a biological product claimed in a patent or the use of which is
 claimed in a patent before the expiration of such patent;
 (B)by adding at the
 end the following paragraph:
 (6)(A)This paragraph applies
 in the case of a patent—
 (i)which is disclosed in a response to
 a request for patent information pursuant to subparagraph (A) of section
 351(k)(18) of the Public Health Service Act;
 (ii)with respect to which a notice was
 provided pursuant to subparagraph (B) of such section; and
 (iii)for which an action for
 infringement of the patent—
 (I)was brought after the expiration of the
 45-day period described in subparagraph (C) of such section; or
 (II)was brought before the expiration of the
 45-day period described in subclause (I), but which was dismissed without
 prejudice or was not prosecuted to judgment in good faith.
 (B)In an action for infringement of a
 patent described in subparagraph (A), the sole and exclusive remedy that may be
 granted by a court, upon a finding that the person who submitted the notice
 described in subparagraph (A)(ii) infringed the patent, or that any person
 induced or contributed to infringement of the patent, shall be a reasonable
 royalty.
 (C)The owner or licensee of a patent that
 should have been disclosed in response to a request for patent information made
 by an applicant pursuant to subparagraph (A) of section 351(k)(18) of the
 Public Health Service Act, but that was not timely disclosed under that
 subparagraph, may not bring an action under this title for infringement of that
 patent.
 ;
 (C)in paragraph
 (5)—
 (i)by
 adding (A) in front of Where; and
 (ii)by
 adding the following subparagraph:
 (B)Where a person has
 provided a notice described in subparagraph (B) of section 351(k)(18) of the
 Public Health Service Act, and neither the holder for the approved biological
 product or the owner of a patent identified in the notice brought an action for
 infringement of such patent before the expiration of 45 days after the date on
 which the notice was received, the courts of the United States shall, to the
 extent consistent with the Constitution, have and exercise subject matter
 jurisdiction in any action brought by such person under section 2201 of title
 28 for a declaratory judgement that such patent is invalid or not
 infringed.
 ;
 and
 (D)in paragraph (4),
 by striking in paragraph (2) in both places it appears and
 inserting in subparagraphs (2)(A) or (2)(B).
 (3)Conforming
 amendments
 (A)Title
 28Section 2201(b) of title 28, United States Code, is amended by
 inserting before the period the following: , or section 351 of the
 Public Health Service Act.
 (B)Public health
 service actSubjection (j) of section 351 of the Public Health
 Service Act (42 U.S.C. 262) is amended by inserting or subsection
 (k) after subsection (a).
 (c)Review of
 applications submitted during exclusivity periods
 (1)User fee
 goals
 (A)RevisionWithin
 180 days after the date of the enactment of this Act, the Secretary of Health
 and Human Services, in consultation with the relevant stakeholders, shall
 revise the PDUFA reauthorization performance goals and procedures with respect
 to the user fee goals for abbreviated biological product applications under
 section 351(k) of the Public Health Service Act, as added by subsection (a) of
 this section, that are submitted more than 2 years in advance of the expiration
 of any period of exclusive marketing to which the reference drug is entitled
 under subsection (k)(10) or subsection (l) of section 351 of the Public Health
 Service Act, as added by subsection (a) of this section and section 4
 respectively.
 (B)ConsiderationsIn
 revising the user fee goals for applications described in subparagraph (A), the
 Secretary shall consider—
 (i)the
 need to provide sufficient time so that a decision on whether to approve the
 application can be made in advance of the expiration of any exclusivity, and
 considering the possibility that amendments will be necessary after the initial
 decision and prior to approval; and
 (ii)the
 importance of conserving agency resources.
 (2)Review
 prioritiesIn setting priorities with respect to the review of
 applications described in paragraph (1)(A), the Secretary shall take into
 account the number of years in advance of the expiration of any exclusivity
 granted to the reference drug that an application was submitted.
 (3)Submission of
 revised performance goals to congressThe Secretary shall, within
 30 days after revising the PDUFA reauthorization performance goals and
 procedures under this subsection, submit to the Committee on Energy and
 Commerce of the House of Representatives and the Committee on Health,
 Education, Labor, and Pensions of the Senate a letter describing the revised
 goals and the basis for such revisions.
 (4)DefinitionsIn
 this subsection:
 (A)The terms
 abbreviated biological product application and reference
 product have the meanings given to those terms in section 351(i) of the
 Public Health Service Act, as amended by section 2(a).
 (B)The term
 PDUFA reauthorization performance goals and procedures means the
 performance goals and procedures of the Food and Drug Administration, agreed to
 for purposes of the reauthorization of part 2 of subchapter C of chapter VII of
 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 279g et seq.; relating to
 the prescription drug user fee program) for fiscal year 2008 and succeeding
 fiscal years.
 4.Pediatric studies
 of biological productsSection
 351 of the Public Health Service Act (42 U.S.C. 262), as amended by section 3,
 is further amended by adding at the end the following:
 (l)Pediatric
 studies
 (1)Application of
 certain provisionsThe provisions of section 505A of the Federal
 Food, Drug, and Cosmetic Act shall, except as inconsistent with this section,
 apply to biological products approved under subsection (a) or (k) of this
 section to the same extent and in the same manner as such provisions apply to
 drugs approved under subsection (c) or (j), respectively, of section 505 of the
 Federal Food, Drug, and Cosmetic Act.
 (2)Market
 exclusively for new biological productsIf, prior to approval of an application
 that is submitted under subsection (a) of this section, the Secretary
 determines that information relating to the use of a new biological product in
 the pediatric population may produce health benefits in that population, the
 Secretary makes a written request for pediatric studies (which shall include a
 timeframe for completing such studies), the applicant agrees to the request,
 such studies are completed using appropriate formulations for each age group
 for which the study is requested within any such timeframe, and the reports
 thereof are submitted and accepted in accordance with section 505A(d)(3) of the
 Federal Food, Drug, and Cosmetic Act—
 (A)the period for such
 biological product referred to in subparagraph (A) of subsection (k)(10),
 including any extension under subparagraph (D) of such subsection, is extended
 by 6 months; and
 (B)if the biological
 product is designated under section 526 for a rare disease or condition, the
 period for such biological product referred to in section 527(a) is deemed to
 be 7 years and 6 months rather than 7 years.
 (3)Market
 exclusivity for already-marketed biological productsIf the Secretary determines that
 information relating to the use of a licensed biological product in the
 pediatric population may produce health benefits in that population and makes a
 written request to the holder of an approved application under subsection (a)
 of this section for pediatric studies (which shall include a timeframe for
 completing such studies), the holder agrees to the request, such studies are
 completed using appropriate formulations for each age group for which the study
 is requested within any such timeframe, and the reports thereof are submitted
 and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug,
 and Cosmetic Act—
 (A)the period for such biological product
 referred to in subparagraph (A) of subsection (k)(10), including any extension
 under subparagraph (D) of such subsection, is extended by 6 months; and
 (B)if the biological
 product is designated under section 526 for a rare disease or condition, the
 period for such biological product referred to in section 527(a) is deemed to
 be 7 years and 6 months rather than 7 years.
 (4)ExceptionThe
 Secretary shall not extend the period referred to in paragraph (2)(A), (2)(B),
 (3)(A), or (3)(B) if the determination under section 505A(d)(3) is made later
 than 9 months prior to the expiration of such
 period.
 .


type: wikipedia

text:
Lashkar Gāh är ett distrikt i Afghanistan. Det ligger i provinsen Helmand, i den centrala delen av landet, kilometer sydväst om huvudstaden Kabul.
 Trakten runt Lashkar Gāh är ofruktbar med lite eller ingen växtlighet. Runt Lashkar Gāh är det ganska tätbefolkat, med invånare per kvadratkilometer. I trakten råder ett hett ökenklimat. Årsmedeltemperaturen i trakten är °C. Den varmaste månaden är juli, då medeltemperaturen är °C, och den kallaste är januari, med °C. Genomsnittlig årsnederbörd är millimeter. Den regnigaste månaden är mars, med i genomsnitt mm nederbörd, och den torraste är juli, med mm nederbörd.
 Källor
 Indelningar i Helmand (provins)


text:
Lääni (ruots. län) on valtion aluehallinnon ylimmästä tasosta Suomessa ja Ruotsissa käytetty nimitys. Lääni on osa valtionhallintoa, eikä sillä ole itsehallintoa, demokraattisesti valittua edustusta tai lainsäädäntövaltaa. Läänin johdossa on hallituksen nimittämä maaherra, joka johtaa lääninhallitusta. Maaherran asemaan on yleisesti nimitetty vanhempia ansioituneita poliitikkoja.
 Ruotsin läänit ovat edelleen olemassa, mutta Suomen läänit lakkautettiin vuoden 2010 alussa. Läänien tilalle Suomessa tulivat aluehallintovirastot.
 Aikaisemmin lääni tarkoitti aluetta, jonka kuningas antoi palkaksi eli läänitykseksi aateliselle tämän valtakunnalle ja kuninkaalle suorittamista palveluksista. Keskiajalta uuden ajan alkuun Ruotsissa oli linnaläänejä valtionhallinon yksiköinä. Vuoden 1634 hallitusmuodossa määrättiin nykyisestä lääninhallinnosta. Lääninhallinnon tehtäviä ja historiaa on kuvattu tarkemmin Suomen ja Ruotsin läänejä käsittelevissä artikkeleissa.
 Norjan, Liettuan ja Tšekin läänit
 Suomen ja Ruotsin lisäksi Norjan, Liettuan ja Tšekin ylimmän tason paikallishallintoalueita on saatettu suomenkielisissä yhteyksissä nimittää lääneiksi. Norjan läänit vastaavat kuitenkin lähinnä Ruotsin maakäräjäkuntia, sillä niillä ne vastaavat eräistä julkisista palveluista ja niitä johtaa vaaleilla valittu toimielin. Liettuan läänit ovat asemaltaan lähempänä Suomen ja Ruotsin läänejä, mutta liettuan kielessä niistä käytetään muuta nimitystä.
 Norjan läänit (norj. fylke)
 Liettuan läänit (liett. apskritis)
 Tšekin läänit (tšek. kraj)
 Katso myös
 Suomen läänit
 Ruotsin läänit
 Tanskan läänit
 Linnalääni
 Läänitys
 Lähteet
 Alankomaat • Albania • Andorra • Armenia2 • Azerbaidžan1 • Belgia • Bosnia ja Hertsegovina • Bulgaria • Espanja • Georgia1 • Irlanti • Islanti • Italia • Itävalta • Kazakstan1 • Kosovo • Kreikka • Kroatia • Kypros2 • Latvia • Liechtenstein • Liettua • Luxemburg • Makedonia • Malta • Moldova • Monaco • Montenegro • Norja • Portugali • Puola • Ranska • Romania • Ruotsi • Saksa • San Marino • Serbia • Slovakia • Slovenia • Suomi • Sveitsi • Tanska • Tšekki • Turkki1 • Ukraina • Unkari • Valko-Venäjä • Venäjä1 • Viro • Yhdistynyt kuningaskunta
 1 Sijaitsee sekä Euroopassa että Aasiassa
 2 Aasiassa sijaitseva, kulttuurihistoriallisesti eurooppalainen valtio
 Paikallishallinto
 Seulonnan keskeiset artikkelit


type: other

text:
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Riiklik Aeronautika- ja Kosmosevalitsus (inglise keeles National Aeronautics and Space Administration, NASA) on 1958. aastal loodud Ameerika Ühendriikide riigiasutus, mille ülesandeks on tsiviil- ja sõjaväelise otstarbega atmosfääri- ja kosmoselennundusuuringute tegemine.
 NASA loodi 29. juulil 1958, kui president Dwight D. Eisenhower allkirjastas National Aeronautics and Space Acti, mis lõpetas NASA eelkäija, NACA tegevuse ja liitis selle loodava agentuuriga. NASA alustas tegevust 1. oktoobril 1958.
 NASA on loomise järel juhtinud suurt osa Ameerika Ühendriikide kosmoseprogrammist. Tuntuimad NASA programmid on Apollo programm, Skylab ja Space Shuttle. Tänapäeval osaleb NASA Rahvusvahelise Kosmosejaama (ISS) töös, arendab Orioni ja Space Launch Systemi ning vastutab kommertsliku meeskonnatranspordi arendamise programmi eest.
 Loomine
 Alates 1946. aastast oli NACA katsetanud rakettlennukeid nagu Bell X-1. 1950. aastatel tekkis väljakutse saata rahvusvaheliseks geofüüsika aastaks (1957–1958) üles tehiskaaslane. Eesmärgini jõudis esimesena Nõukogude Liit, mis saatis 4. oktoobril 1957 orbiidile Sputniku. 6. detsembril 1957 proovis USA saata orbiidile oma esimese tehiskaaslase, kuid Vanguard TV3 start ebaõnnestus.
 14. jaanuaril 1958 teatas NACA peadirektor Hugh Dryden, et kosmoselendude jaoks peaks moodustama uue kosmoseagentuuri, mis oleks tsiviilasutus. Veebruaris 1958 loodi DARPA, mille üheks eesmärgiks on sõjalise kosmosetehnoloogia väljatöötamine. 29. juulil 1958 allkirjastas president National Aeronautics and Space Acti, millega loodi NASA. Riiklik Aeronautika Nõuandekomitee liideti 1. oktoobril 1958 tegevust alustanud NASA-ga ning uus agentuur omandas ka NACA personali, uurimiskeskused ja eelarve. Lisaks võeti üle ka mitu sõjaväe kosmoseprogrammi. Uude kosmoseagentuuri asusid tööle mitmed varem sõjaväe heaks töötanud teadlased, sealhulgas Werner von Braun. Detsembris 1958 omandas NASA Jet Propulsion Laboratory, mida tänapäeval juhib NASA nimel California Tehnoloogiainstituut.
 Juhtimine
 NASA-t juhib peadirektor, kelle määrab USA president ja ametisse kinnitab senat. Peadirektor allub otse presidendile ning on ka presidendi kosmoseteaduse vanemnõunik. NASA on poliitiliselt erapooletu organisatsioon, kuid tavaliselt on agentuuri peadirektor seotud ametisoleva presidendi erakonnaga ja uus peadirektor määratakse tavaliselt presidendi partei vahetudes. Seni on NASA peadirektorite hulgas olnud kolm inimest, James Fletcher, Daniel Goldin ja Robert M. Lightfoot, keda pole presidendi erakonna vahetumise järel välja vahetatud. NASA on küll iseseisev asutus, kuid selle projektide jätkumine või lõpetamine võib otseselt sõltuda ametisoleva presidendi otsustest.
 Alates 3. maist 2021 on NASA peadirektor Bill Nelson.
 Visioon ja missioon
 NASA tulevikunägemus kätkeb maapealse elu paranemist ja selle levimist kosmosesse ning kaugemalt elu leidmist. Oma ülesandeks on NASA seadnud meie koduplaneedi mõistmise ja kaitsmise, universumi uurimise, mujalt elu leidmise ja uue kosmoseuurijate põlvkonna innustamise.
 Kosmoseprogrammid
 NASA on oma tegevusaja jooksul korraldanud mitmeid mehitatud ja mehitamata kosmoselendude programme. Mehitamata missioonide raames saatis NASA orbiidile esimesed satelliidid ning uuris kosmosesondide abil Veenust, Marssi ja teisi Päikesesüsteemi planeete. Mehitatud missioonide raames saadeti orbiidile esimesed astronaudid ning aastatel 1969–1972 maandusid Kuule kuus missiooni. Pärast Apollo programmi lõppu ehitas NASA Skylabi, osaliselt taaskasutatava Space Shuttle'i ning asus koos teiste riikidega ehitama Rahvusvahelist Kosmosejaama. Mõni missioon oli samaaegselt mehitatud ning mehitamata missioon, sest näiteks kosmosesond Galileo viidi kosmosesse kosmosesüstikuga ja selle paigutasid orbiidile astronaudid, misjärel suundus see iseseisvalt Jupiterile.
 Mehitatud lendude programmid
 X-15 (1959–1968)
 X-15 oli NACA eksperimentaalne rakettlennuk, mida arendati koos USA õhuväe ja mereväega. Lennuk oli projekteeritud sihvaka kerega ning sellel kasutati ka varaseid arvuteid. X-15 lennukeid ehitas North American Aviation kolm eksemplari ning rakettmootorid tarnis Reaction Motors. X-15 rakettlennuki katselend algas NASA B-52 Stratofortressi küljest eraldumisega ajal, kui lennuk oli 14 kilomeetri kõrgusel ja liikus kiirusel 805 km/h. Rakettmootor töötas eraldumise järel tavaliselt 80–120 sekundit ja seejärel laugles lennuk enne maandumist veel 10–11 minutit.
 X-15 programmi valiti õhuväe, mereväe ja NACA (hiljem NASA) personali hulgast 12 lendurit ning kokku sooritati 199 katselendu. Programmi raames püstitati mitmeid rekordeid ja kaheksa pilooti said õhuväe astronaudimärgi. Kahel katselennul lendas Joseph Walker üle 100 km kõrgusele, ületades kosmose piiri ning oli seega esimene inimene, kes käis kosmoses mitu korda. Katselendude raames testiti mitmeid tehnoloogiaid, mida kasutati hilisematel mehitatud lendudel ning atmosfääri sisenemisel ja maandumisel kogutud informatsioon aitas NASA-t Space Shuttle'i projekteerimisel.
 Mercury programm (1959–1963)
 Varsti pärast kosmose võidujooksu algust, oli esmaseks eesmärgiks saata võimalikult kiiresti esimene inimene kosmosesse ja seetõttu eelistati ehitada kosmoselaev, mida saaks kosmosesse viia olemasolevate rakettidega. Enne NASA loomist tegeles inimese kosmosesse viimise programmidega õhuvägi ning kaaluti mitmeid variante alates rakettlennukitest nagu X-15 kuni väikeste kapsliteni. 1958. aastaks oli õhuvägi otsustanud kapsli ehitamise kasuks.
 NASA loomise järel, õhuväe mehitatud kosmoselennu programm lõpetati ning NASA alustas Mercury programmi. Esimesed seitse NASA astronauti valiti mereväe, õhuväe ja merejalaväe katselendurite hulgast ja 5. mail jõudis Alan Shepard esimese ameeriklasena kosmosesse, kuid seda jäi varjutama asjaolu, et 12. aprillil, kõigest kolm nädalat enne Shepardi lendu, oli kosmoses käinud Juri Gagarin, kes sai esimeseks inimeseks kosmoses. 20. veebruaril 1962 tegi esimese ameeriklasena kolm tiiru ümber Maa John Glenn ning pärast veel kolme missiooni, lõpetas programmi Gordon Cooper, kes tegi mais 1963 22 tiiru Maa orbiidil.
 Mercury programmi edu viis Gemini programmini, mille raames harjutati põkkumist ja teisi Kuule lennuks olulisi manöövreid, sest paar nädalat pärast Alan Shepardi lendu, kuulutas president John F. Kennedy välja Apollo programmi.
 Gemini programm (1961–1966)
 Apollo programmi jaoks pidid NASA astronaudid saama pikkade lendude kogemuse ning õppima põkkuma, avakosmoses töötama ja väga täpselt maanduma. Nende kogemuste omandamiseks alustas NASA Gemini programmi ja esimene mehitatud missioon, Gemini 3, startis 1965. aastal. Pärast seda toimus veel üheksa Gemini missiooni ning pikim neist, Gemini 7, kestis kaks nädalat. Missioonide ajal harjutasid astronaudid kosmoses objektidele lähenemist, põkkumist, avakosmoses töötamist. Missioonide ajal uurisid teadlased astronautide abil kaalutuse mõju inimesele.
 Apollo programm (1961–1972)
 Ameerika Ühendriikide üldsuse arvamus, et Nõukogude Liit juhib kosmose võidujooksu, motiveeris president Kennedy algatama Apollo programmi, seades eesmärgiks maandada Kuule enne kümnendi lõppu mehitatud missioon.
 Apollo oli Ameerika Ühendriikide kallemaid teadusprogramme. Programmi maksumus tänapäeva rahas (seisuga 2014) oli umbes 200 miljardit dollarit (näiteks Manhattani projekt maksis umbes 26,6 miljardit dollarit). Missioonide jaoks töötati välja kanderaketid Saturn, mis olid tunduvalt suuremad kui varasematel lendudel kasutatud kanderaketid. Missioonidel kasutatud kosmoselaev oli samuti suurem ja see koosnes teenindus- ja juhtimismoodulist ja kuumoodulist, millest kuumoodul jäeti Kuule ja Maale tagasi jõudis ainult juhtimismoodul.
 Apollo programmi teine missioon, Apollo 8, saadeti tiirlema Kuu orbiidile ning NASA sai selle missiooniga esimeseks kosmoseagentuuriks, mis saatis astronaudid teise taevakeha orbiidile tiirlema. Apollo 9 ja Apollo 10 ajal katsetati Maa ja Kuu orbiidil kuumoodulit. Pärast seda maandus Kuule missioon Apollo 11 ning esimesteks Kuu pinnal käinud inimesteks said Neil Armstrong ja Buzz Aldrin.
 Pärast esimest maandumist toimus veel viis maandumist ning kokku kõndis Kuu pinnal 12 astronauti. Seni viimane mehitatud missioon naasis Kuult detsembris 1972. Apollo missioonidel toodi Kuult Maale 381 kg kivimeid ja tehti mitmeid katseid, uurides päikesetuult ning Kuu kraatreid, pealispinda, seismoloogiat, temperatuuri ja magnetvälja.
 Skylab (1965–1979)
 Skylab oli NASA esimene ja ainus iseseisvalt ehitatud kosmosejaam. Jaam viidi orbiidile 14. mail 1973, kasutades kanderaketti Saturn V. Jaama kuumuskilp ja üks päikesepaneelidest said stardil kahjustada, kuid jaama saabunud esimene meeskond parandas mõlemad ära. Skylabis elas aastatel 1973–1974 kolm meeskonda ning kokku elasid meeskonnad jaamas 171 päeva. Kosmosejaamas uuriti peamiselt kaalutuse mõjusid inimesele ning vaadeldi Päikest. NASA plaanis jaama viia kosmosesüstiku abil kõrgemale orbiidile, kuid see polnud veel valmis, kui jaam 11. juulil 1979 Maa atmosfääri sisenes ja ära põles.
 Space Shuttle (1972–2011)
 Space Shuttle sai NASA peamiseks projektiks 1970. aastate lõpus ja 1980. aastatel. Need olid planeeritud olema enamjaolt taaskasutatavad ja sageli startivad kosmoselennukid ning esimesed neli kosmosesüstikut valmisid 1985. aastaks. Esimene kosmosesüstik, mis jõudis kosmosesse, oli Columbia, mis startis oma esimesele missioonile 12. aprillil 1981.
 Space Shuttle oli stardil kinnitatud kahe tahkekütuskiirendi ja väliskütusepaagi külge, millest viimane oli ainus komponent, mida ei saanud taaskasutada. Süstikute orbiidi kõrgus oli tavaliselt vahemikus 185–643 km ja need suutsid kosmosesse viia kuni 24,4 tonni kaaluva lasti. Missioonid kestsid tavaliselt 5–17 päeva ja meeskond koosnes 2–8 astronaudist.
 Aastatel 1983–1998 oli 20 missioonil kosmosesüstikute pardal Spacelab, mille ESA oli projekteerinud koos NASA-ga. See oli taaskasutatav laborimoodul, mis paiknes missiooni ajal kosmosesüstiku lastiruumis ning astronaudid pääsesid moodulisse õhulüüsiga ühendatud tunneli kaudu. Teised tuntumad missioonid olid 1990. aastal toimunud Hubble'i kosmoseteleskoobi orbiidile viimine, 1993. aastal edukas Hubble'i parandusmissioon ja Shuttle-Miri missioonid, mille raames põkkusid kosmosesüstikud Vene kosmosejaamaga Mir.
 NASA kaotas Space Shuttle'i programmi jooksul kaks kosmosesüstikut ja 14 astronauti. 1986. aastal plahvatas stardil kosmosesüstik Challenger ning 2003. aastal purunes Maa atmosfääri sisenemisel kosmosesüstik Columbia. NASA ehitas Challengeri asenduseks Endeavouri, kuid Columbia asendamiseks uut süstikut enam ei ehitatud. Programmi jooksul toimus 135 missiooni ning kosmoses käis üle 300 astronaudi. Programm lõpetati 2011. aastal.
 Kommertslik meeskonnatranspordi arendamise programm (2010–)
 Kommertsliku meeskonnatranspordi arendamise programm (CCDev) käivitati 2010. aastal ja selle eesmärgiks seati erafirmade arendatud mehitatud kosmoselaevade kasutusele võtmine, mis suudaksid transportida vähemalt nelja inimest, põkkuda ISS-iga vähemalt 180 päevaks ja naasta seejärel Maale. Lisaks loodetakse nende laevadega hakata erakosmosejaamadesse vedama ka erakliente.
 2010. aastal avalikustas NASA programmi esimese faasi viis võitjat, kelle vahel jagati ära 50 miljonit dollarit. 2011. aastal avalikustati teise faasi võitnud neli firmat, kelle vahel jagati ära 270 miljonit dollarit. 2012. aastal avalikustas NASA kolmanda faasi võitnud kolm firmat, kelle vahel läks jagamisele 1,1 miljardit dollarit. 2014. aastal selgusid viimase faasi kaks võitjat. SpaceX-i arendatav Dragon sai NASA-lt lepingu, mille väärtus on 2,6 miljardit dollarit ja Boeingu CST-100 Starliner sai lepingu, mille väärtuseks on 4,2 miljardit dollarit.
 Dragoni esimene mehitatud lend startis mais 2020 ja naasis Maale augustis. CST-100 esimene mehitatud lend pidi toimuma juulis 2021.
 Space Launch System ja Orion
 2010. aastal tühistas Barack Obama administratsioon Constellationi programmi ning tegi ettepaneku anda erafirmadele ISS-i varustamismissioonide korraldamisel suurem vastutus. Aprillis 2015 pidas Obama Kennedy Kosmosekeskuses kõne, milles tegi ettepaneku korraldada 2025. aastal mehitatud missioon asteroidile ning saata 2030. aastate keskpaigas mehitatud missioon Marsi orbiidile. NASA alustas pärast Space Shuttle'i lendude lõppemist Space Launch Systemi (SLS) ja Orioni projekteerimist..' NASA plaanide kohaselt peaks Orion mahutama kuni 6 astronauti ning SLS viima Maa orbiidile 130 tonni.
 Esimene Orioni katselend toimus 2014. aastal.
 Mehitamata lendude programmid
 Esimene USA satelliit, mis jõudis orbiidile, oli Explorer 1, mis startis kaks kuud pärast Sputnikut. Pärast NASA loomist, võttis see Exploreri programmi üle ning see on endiselt aktiivne NASA programm. Programmi missioonid keskenduvad Maale ja Päikesele, mõõtes muuhulgas ka magnetvälju ja päikesetuult.
 Päikesesüsteemi siseosa uurimine on olnud vähemalt nelja NASA programmi eesmärgiks. Esimene programm oli Marineri programm, mille raames saadeti kosmosesondid uurima Merkuuri, Veenust ja Marssi. Marineri programmi raames sooritas Mariner 2 esimese möödalennu teisest planeedist, Mariner 4 pildistas esmakordselt teist planeeti, Mariner 9 jäi teise planeedi orbiidile tiirlema ning Mariner 10 kasutas gravitatsioonitõmmet.
 1970. aastatel uuris NASA Vikingi programmi raames Marssi ning 1976. aastal maandus Marsile Viking 1, mis oli esimene edukas maandumine Marsil. Pärast Vikingi missioonide lõppu, tekkis NASA Marsi uuringutesse paus, mis kestis üle kümne aasta. NASA taasalustas Marsi uurimist 1990. aastatel, kui juulis 1997 maandus Marsile Mars Pathfinder ja septembris jäi Marsi orbiidile Mars Global Surveyor.
 1973. aastal külastas Jupiteri esmakordselt NASA sond, Pioneer 10, ja rohkem kui 20 aastat hiljem jäi Galileo esimese kosmosesondina Jupiteri orbiidile tiirlema. 1979. aastal külastas Pioneer 11 Saturni ja Voyager 2 sai seni ainsaks kosmosesondiks, mis on möödunud Uraanist ja Neptuunist. Pioneer 10 oli pikka aega kaugeimale jõudnud kosmosesond, kuid 1998. aastal möödus sellest Voyager 1, mis lahkus 2012. aastal Päikesesüsteemist.
 Hiljutised ja praegused tegevused
 NASA käimasolevate missioonide hulka kuuluvad Marsi uurimismissioonid (Mars 2020 ja InSight), Saturni uurimine ning Maa ja Päikese uurimine. Lisaks uurib kosmosesond Juno Jupiteri, New Horizons Päikesesüsteemi välisosa ja Voyagerid Päikesesüsteemi piirialasid. 2021. aastal peaks Maa orbiidile jõudma James Webbi kosmoseteleskoop, mida NASA on kirjeldanud kui Hubble'i kosmoseteleskoobi järglast.
 Alates 2011. aastast on NASA eesmärgid järgmised:
 Mehitatud kosmoselendude arvu suurendamine ja säilitamine
 Maa ja Universumi teaduslike uuringute laiendamine
 Innovatiivsete uute kosmosetehnoloogiate arendamine
 NASA informatsiooni jagamine üldsuse, õpetajate ja õpilastega, et võimaldada nende osalus NASA programmides
 Allüksused
 NASA allüksused on uurimis-, ehitus- ja sidekeskused, mis toetavad kosmoseagentuuri missioone. NASA allüksustest neli rajas NACA, kaks maavägi ja ülejäänud ehitas NASA.
 NACA rajatud uurimiskeskused
 Langley Uurimiskeskus (LaRC) asub Hamptonis Virginia osariigis. LaRC keskendub aeronautikale, kuid seal katsetati näiteks Apollo kuumoodulit ning planeeriti mitmed suuremad kosmosemissioonid.
 Amesi Uurimiskeskus rajati 1939. aastal ning see asub California osariigis. Keskus nimetati NACA asutajaliikme Joseph Sweetman Amesi järgi. Amesi Uurimiskeskus tegeles esmalt lennuvahendite tuuletunnelis uurimisega, kuid hiljem on keskuse varasematele ülesannetele lisandunud aeronautika ja kosmoselendude tehnoloogia ning infotehnoloogiauuringud ja arendustöö.
 Glenni Uurimiskeskus asub Ohio osariigis ning selle põhilised ülesanded on krüogeenika, side, energia salvestamine ja muundamine, katsed mikrogravitatsioonis ning materjaliteadus.
 Armstrongi Lennu-uuringute Keskus asub California osariigis, Edwardsi õhuväebaasis ning see tegeleb aeronautikauuringutega. Keskus käitab ka mitmeid NASA lennumasinaid, sealhulgas Stratospheric Observatory for Infrared Astronomyt.
 Maaväe rajatud uurimiskeskused
 Jet Propulsion Laboratory (JPL) asub Californias ning seda haldab California Tehnoloogiainstituut. JPLi peamised ülesanded on kosmoseaparaatide ehitamine ja käitamine ning Maa orbiidil tiirlevate ja astronoomiamissioonide korraldamine. Veel vastutab JPL Süvakosmose sidevõrgu käitamise eest.
 Marshalli Kosmosekeskus asub Alabama osariigis ning see on suurimaid NASA allüksusi. Marshall vastutab Rahvusvahelise Kosmosejaama USA segmendi töö eest ning arendab rakettmootoreid ja mitmeid kosmoses kasutatavaid süsteeme.
 NASA rajatud uurimiskeskused
 Goddardi Kosmosekeskus asub Marylandi osariigis ning see rajati 1959. aastal. Keskus vastutab mehitamata kosmoseaparaatide arendamise ja ehituse eest ning käitab mitut kosmoseaparaatidega suhtlemiseks vajalikku sidevõrku. Goddardi Kosmosekeskus haldab Maad, Päikest, teisi planeete ja astrofüüsikat uurivaid missioone.
 John C. Stennise Kosmosekeskus asub Mississippi osariigis ning see vastutab rakettmootorite arenduse eest.
 Lyndon B. Johnsoni Kosmosekeskus asub Texases ning see vastutab NASA mehitatud kosmoselendude maapealse juhtimise eest. Keskuses asub NASA astronaudikorpus ning seal koolitatakse NASA ja partnerriikide astronaute.
 Kennedy Kosmosekeskus asub Florida osariigis ning see on NASA tuntumaid keskusi, kust on alates 1968. aastast startinud kõik USA mehitatud missioonid. Kosmosekeskuses paikneb 39. stardikompleks. Keskus on nimetatud president John F. Kennedy auks.
 Eelarve
 NASA eelarve on tavaliselt umbes 1% föderaaleelarvest ning suurim oli see 1966. aastal, kui NASA eelarve moodustas föderaaleelarvest 4,41%. Samas erineb üldsuse arvamus NASA eelarvest tunduvalt, sest 1997. aastal ameeriklaste seas korraldatud küsitluse tulemuste kohaselt, arvas enamus vastanutest, et NASA eelarve moodustab 20% föderaalsest eelarvest. NASA eelarve on pidevalt vähenenud alates Apollo programmist ja 2017. aastal oli see 19,5 miljardit dollarit ehk 0,489% föderaalsest eelarvest.
 Vaata ka
 NASA kosmosemissioonide loend
 Mercury Seven
 Viited
 Välislingid
 NASA koduleht
 Ameerika Ühendriikide valitsusagentuurid
 Kosmoseagentuurid


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Las Meninas (bl-Ispanjol għal Xbejbiet għas-Servizz tar-Reġina) hija pittura tal-1656 ta' Diego Velázquez, l-artist li mexxa l-Epoka tad-Deheb Spanjola, li tinsab fil-Museo del Prado f'Madrid. Il-kompożizzjoni kumplessa u enigmatika tax-xogħol tqajjem mistoqsijiet dwar ir-realtà u l-illużjoni u toħloq relazzjoni inċerta bejn l-osservatur u l-figuri murija. Minħabba dawn il-kumplessitajiet, Las Meninas kienet waħda mill-iżjed xogħlijiet analizzati fil-pittura Oċċidentali.
 Las Meninas turi kamra kbira fil-palazz ta' Madrid tar-Re Filippu IV ta' Spanja, u turi bosta figuri li ħafna minnhom huma membri tar-residenza tas-sovran Spanjol. Skont xi kummentaturi, dawn inqabdu f'mument partikolari daqs li kieku itteħdilhom ritratt. Xi wħud mill-figuri jħarsu lejn l-osservatur filwaqt li oħrajn jinteraġixxu bejniethom.
 Pitturi ta' Diego Velázquez