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

Example Input: SECTION 1. FINDINGS.

    Congress finds that--
            (1) the historical significance of the 52-mile Going-to-
        the-Sun Road in Glacier National Park, Montana, is recognized 
        by its--
                    (A) listing on the National Register of Historic 
                Places in 1983;
                    (B) designation as a National Historic Engineering 
                Landmark by the American Society of Civil Engineers in 
                1985; and
                    (C) designation as a National Historic Landmark in 
                1997;
            (2) in 1997, recommendations of the Federal Highway 
        Administration concerning, and an engineering study of, the 
        Road verified significant structural damage to the Road has 
        occurred since the Road opened in 1932;
            (3) infrastructure at most of the developed areas in the 
        Park is inadequate for cold-season (fall, winter, and spring) 
        operation, and maintenance backlog needs exist for normal 
        summer operation;
            (4) the Many Glacier Hotel and Lake McDonald Lodge are on 
        the National Register of Historic Places and are National 
        Historic Landmarks;
            (5) other accommodations operated by the concessionaire 
        that have possessory interest and are listed on the National 
        Register of Historic Places are the Rising Sun Motor Inn and 
        Swiftcurrent Motel;
            (6) the historic hotels in the Park, operated under 
        concession agreements with the National Park Service, are 
        essential for public use and enjoyment of the Park;
            (7) visitors to the Park deserve safe hotels in the Park 
        that meet basic needs and expectations;
            (8) the historic hotels in the Park have deteriorated 
        significantly and need substantial repair;
            (9) repairs of the hotels in the Park have been deferred 
        for so long that, absent any changes to the Federal law 
        governing concessionaires and the availability of historic tax 
        credits for up to 39.5 years, the remodeling costs for the 
        hotels exceed the capacity of the hotel concessionaire to 
        finance the repairs with hotel revenues;
            (10) the remodeling costs of Park hotels are so high that 
        the concessionaire will need to finance the cost of those 
        repairs by borrowing the remodeling expenses and repaying them 
        over time out of net hotel income, which by current law is 
        limited to 20-year concession agreements;
            (11) the season of operation for hotels is about 4 months 
        because the developed areas of the Park lack--
                    (A) water, sewer, and fire protection systems that 
                can operate in freezing conditions;
                    (B) building insulation; and
                    (C) heating systems;
            (12) because of many factors, including the high projected 
        costs of remodeling, the relatively short tourist season in the 
        Park, and the requirement that concession agreements may not 
        exceed 20 years, concessionaires are unable to carry out the 
        scope of remodeling that is needed for the hotels in the Park;
            (13) the National Park Service Concessions Management 
        Improvement Act of 1998 (16 U.S.C. 5951 et seq.) is based on 
        sound principles and is achieving its basic purposes, but there 
        appear to be selected instances in which the National Park 
        Service needs additional authority to conduct demonstration 
        projects; and
            (14) a demonstration project is needed to carry out repairs 
        of the historic hotels in the Park.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Committee.--The term ``Committee'' means the Going-to-
        the-Sun Road Citizens' Advisory Committee.
            (2) Park.--The term ``Park'' means Glacier National Park, 
        Montana.
            (3) Road.--The term ``Road'' means Going-to-the-Sun Road, 
        located in the Park.
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of the Interior.

SEC. 3. GOING-TO-THE-SUN ROAD FEASIBILITY STUDY AND REHABILITATION 
              PLAN.

    (a) Feasibility Study.--
            (1) In general.--Not later than June 30, 2001, the 
        Secretary, in consultation with the Committee, shall complete a 
        feasibility study for rehabilitation of the Road.
            (2) Inclusions.--The feasibility study shall include--
                    (A) alternative plans for rehabilitation of the 
                Road, including--
                            (i) a ranking of the feasibility of each 
                        plan;
                            (ii) an estimate of the length of time 
                        necessary to complete each plan;
                            (iii) a description of which mitigation 
                        efforts would be used to preserve resources and 
                        minimize adverse economic effects of each plan;
                            (iv) an analysis of the costs and benefits 
                        of each plan;
                            (v) an estimate of the cost of each plan;
                    (B) an analysis of long-term maintenance needs, 
                standards, and schedules for the Road, alternatives to 
                accomplish the work, maintenance staff needs, and 
                associated cost estimates; and
                    (C) a complete environmental analysis that meets 
                any applicable requirement of--
                            (i) the National Environmental Policy Act 
                        of 1969 (42 U.S.C. 4321 et seq.);
                            (ii) the National Historic Preservation Act 
                        (16 U.S.C. 470 et seq.); and
                            (iii) any other applicable law.
            (3) Submission.--Not later than 30 days after completion of 
        the feasibility study, the Secretary shall submit to the 
        Committee on Resources in the House of Representatives and the 
        Committee on Energy and Natural Resources in the Senate a copy 
        of the study.
    (b) Rehabilitation Plan.--
            (1) In general.--As soon as practicable after completing 
        the study and environmental analysis under subsection (a), the 
        Secretary shall--
                    (A) consider the recommendations of the Committee;
                    (B) make any decision documented in the 
                environmental analysis process; and
                    (C) select and implement a rehabilitation plan for 
                the Road.
            (2) Authorized actions.--In implementing a rehabilitation 
        plan under this subsection, the Secretary may--
                    (A) use funds to--
                            (i) rehabilitate the Road; and
                            (ii) carry out transportation system 
                        improvements or impact mitigation activities 
                        outside the Park, if recommended in the 
                        feasibility study and by the Committee; and
                    (B) seek funding for any long-term maintenance 
                needs identified in the feasibility study.
            (3) Authorization of appropriations.--There is authorized 
        to be appropriated to the Secretary to implement the 
        rehabilitation plan (including the cost of any necessary 
        environmental or cultural documentation and monitoring), 
        $200,000,000.
    (c) Continuation of Maintenance.--Nothing in this section affects 
the duty of the Secretary to continue the program in effect on the day 
before the date of the enactment of this Act to preserve, maintain, and 
address safety concerns relating to the Road.

SEC. 4. MAINTENANCE AND UPGRADE OF UTILITY
              SYSTEMS.

    (a) In General.--As soon as practicable after funds are made 
available under this section, the Secretary shall begin the upgrade and 
continue the maintenance of utility systems that serve the Park and 
facilities relating to the Park.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to the Secretary to carry out this section, $20,000,000.

SEC. 5. HOTEL REHABILITATION.

    (a) Competitive Leases of Property.--Notwithstanding section 3(k) 
of Public Law 91-383 (commonly known as the ``National Park System 
General Authorities Act'') (16 U.S.C. 1a-2) or any other provision of 
law, subject to subsection (b), the Secretary may enter into a 
competitive lease of Federal property in the Park under which a lessee 
may provide visitor services to visitors to the area.
    (b) Mandatory Conditions of Leases.--
            (1) In general.--The Secretary shall enter into a lease 
        under subsection (a) only after determining that the provision 
        of visitor services--
                    (A) is necessary and appropriate for the 
                accommodation of visitors to the Park, taking into 
                consideration the value of providing additional visitor 
                services (including conference facilities) for groups 
                of visitors in the early spring and late fall months, 
                especially as those additional services may provide 
                extra revenue needed to finance improvements for the 
                historic hotels in Glacier National Park; and
                    (B) is consistent with section 402 of the National 
                Park Service Concessions Management Improvement Act of 
                1998 (16 U.S.C. 5952).
            (2) Terms and conditions.--The Secretary shall include in a 
        lease under this subsection appropriate terms and conditions to 
        ensure, to the maximum extent practicable, that--
                    (A) any visitor service provided is--
                            (i) adequate; and
                            (ii) available at a reasonable rate--
                                    (I) to be approved by the Secretary 
                                in accordance with section 406 of the 
                                National Park Service Concessions 
                                Management Improvement Act of 1998 (16 
                                U.S.C. 5951 et seq.); and
                                    (II) that may be at such a level as 
                                to allow any investment in capital 
                                improvements for visitor services to be 
                                recovered within a reasonable amount of 
                                time by the concessionaire that 
                                financed the improvements;
                    (B) the leased property will be properly maintained 
                by the lessee, and, with respect to historic property 
                that may be leased, preserved, and maintained in a 
                manner consistent with the historic character of the 
                property, as determined by the Secretary; and
                    (C) assure the lessee of adequate protection 
                against any loss of investment in an improvement to 
                real property that the lessee may make to the leased 
                property (including an obligation of the United States 
                to compensate the lessee for any loss of investment in 
                an improvement to real property in any circumstances 
                that the Secretary determines to be prudent).
    (c) Leasehold Surrender Value.--In any contract for improvements, 
the Secretary shall recognize the leasehold surrender value of any 
existing lease that the Secretary may require to be surrendered in any 
action that is associated with approving an improvement to visitor 
services under this section.
Example Output: Directs the Secretary to upgrade and continue the maintenance of utility systems which service the Park and its related facilities. Authorizes appropriations.
Authorizes the Secretary to enter into competitive leases of federally-owned property in the Park under which the lessee will be authorized to provide visitor services (including a hotel), subject to specified conditions.

Example Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Devices Technical 
Corrections Act''.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.

    (a) Title I; Fees Relating to Medical Devices.--Part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i et seq.), as added by section 102 of Public Law 107-250 
(116 Stat. 1589), is amended--
        (1) in section 737--
            (A) in paragraph (4)(B), by striking ``and for which 
        clinical data are generally necessary to provide a reasonable 
        assurance of safety and effectiveness'' and inserting ``and for 
        which substantial clinical data are necessary to provide a 
        reasonable assurance of safety and effectiveness'';
            (B) in paragraph (4)(D), by striking ``manufacturing,'';
            (C) in paragraph (5)(J), by striking ``a premarket 
        application'' and all that follows and inserting ``a premarket 
        application or premarket report under section 515 or a 
        premarket application under section 351 of the Public Health 
        Service Act.''; and
            (D) in paragraph (8), by striking ``The term `affiliate' 
        means a business entity that has a relationship with a second 
        business entity'' and inserting ``The term `affiliate' means a 
        business entity that has a relationship with a second business 
        entity (whether domestic or international)''; and
        (2) in section 738--
            (A) in subsection (a)(1)--
                (i) in subparagraph (A)--

                    (I) in the matter preceding clause (i) by striking 
                ``subsection (d),'' and inserting ``subsections (d) and 
                (e),'';
                    (II) in clause (iv), by striking ``clause (i),'' 
                and all that follows and inserting ``clause (i).''; and
                    (III) in clause (vii), by striking ``clause (i),'' 
                and all that follows and inserting ``clause (i), 
                subject to any adjustment under subsection 
                (e)(2)(C)(ii).''; and

                (ii) in subparagraph (D), in each of clauses (i) and 
            (ii), by striking ``application'' and inserting 
            ``application, report,'';
            (B) in subsection (d)(2)(B), beginning in the second 
        sentence, by striking ``firms. which show'' and inserting 
        ``firms, which show'';
            (C) in subsection (e)--
                (i) in paragraph (1), by striking ``Where'' and 
            inserting ``For fiscal year 2004 and each subsequent fiscal 
            year, where''; and
                (ii) in paragraph (2)--

                    (I) in subparagraph (B), beginning in the second 
                sentence, by striking ``firms. which show'' and 
                inserting ``firms, which show''; and
                    (II) in subparagraph (C)(i), by striking ``Where'' 
                and inserting ``For fiscal year 2004 and each 
                subsequent fiscal year, where'';

            (D) in subsection (f), by striking ``for filing''; and
            (E) in subsection (h)(2)(B)--
                (i) in clause (ii), by redesignating subclauses (I) and 
            (II) as items (aa) and (bb), respectively;
                (ii) by redesignating clauses (i) and (ii) as 
            subclauses (I) and (II), respectively;
                (iii) by striking ``The Secretary'' and inserting the 
            following:
                ``(i) In general.--The Secretary''; and
                (iv) by adding at the end the following:
                ``(ii) More than 5 percent.--To the extent such costs 
            are more than 5 percent below the specified level in 
            subparagraph (A)(ii), fees may not be collected under this 
            section for that fiscal year.''.
    (b) Title II; Amendments Regarding Regulation of Medical Devices.--
        (1) Inspections by accredited persons.--Section 704(g) of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as added 
    by section 201 of Public Law 107-250 (116 Stat. 1602), is amended--
            (A) in paragraph (1), in the first sentence, by striking 
        ``conducting inspections'' and all that follows and inserting 
        ``conducting inspections of establishments that manufacture, 
        prepare, propagate, compound, or process class II or class III 
        devices, which inspections are required under section 510(h) or 
        are inspections of such establishments required to register 
        under section 510(i).'';
            (B) in paragraph (5)(B), in the first sentence, by striking 
        ``or poses'' and all that follows through the period and 
        inserting ``poses a threat to public health, fails to act in a 
        manner that is consistent with the purposes of this subsection, 
        or where the Secretary determines that there is a financial 
        conflict of interest in the relationship between the accredited 
        person and the owner or operator of a device establishment that 
        the accredited person has inspected under this subsection.'';
            (C) in paragraph (6)(A)--
                (i) in clause (i), by striking ``of the establishment 
            pursuant to subsection (h) or (i) of section 510'' and 
            inserting ``described in paragraph (1)'';
                (ii) in clause (ii)--

                    (I) in the matter preceding subclause (I)--

                        (aa) by striking ``each inspection'' and 
                    inserting ``inspections''; and
                        (bb) by inserting ``during a 2-year period'' 
                    after ``person''; and

                    (II) in subclause (I), by striking ``such a 
                person'' and inserting ``an accredited person'';

                (iii) in clause (iii)--

                    (I) in the matter preceding subclause (I), by 
                striking ``and the following additional conditions are 
                met:'' and inserting ``and 1 or both of the following 
                additional conditions are met:'';
                    (II) in subclause (I), by striking ``accredited'' 
                and all that follows through the period and inserting 
                ``(accredited under paragraph (2) and identified under 
                clause (ii)(II)) as a person authorized to conduct such 
                inspections of device establishments.''; and
                    (III) in subclause (II), by inserting ``or by a 
                person accredited under paragraph (2)'' after ``by the 
                Secretary'';

                (iv) in clause (iv)(I)--

                    (I) in the first sentence--

                        (aa) by striking ``the two immediately 
                    preceding inspections of the establishment'' and 
                    inserting ``inspections of the establishment during 
                    the previous 4 years''; and
                        (bb) by inserting ``section'' after ``pursuant 
                    to'';

                    (II) in the third sentence--

                        (aa) by striking ``the petition states a 
                    commercial reason for the waiver;''; and
                        (bb) by inserting ``not'' after ``the Secretary 
                    has not determined that the public health would''; 
                    and

                    (III) in the fourth sentence, by striking ``granted 
                until'' and inserting ``granted or deemed to be granted 
                until''; and

                (v) in clause (iv)(II)--

                    (I) by inserting ``of a device establishment 
                required to register'' after ``to be conducted''; and
                    (II) by inserting ``section'' after ``pursuant 
                to'';

            (D) in paragraph (6)(B)(iii)--
                (i) in the first sentence, by striking ``, and data 
            otherwise describing whether the establishment has 
            consistently been in compliance with sections 501 and 502 
            and other'' and inserting ``and with other''; and
                (ii) in the second sentence--

                    (I) by striking ``inspections'' and inserting 
                ``inspectional findings''; and
                    (II) by inserting ``relevant'' after ``together 
                with all other'';

            (E) in paragraph (6)(B)(iv)--
                (i) by inserting ``(I)'' after ``(iv)''; and
                (ii) by adding at the end the following:
    ``(II) If, during the two-year period following clearance under 
subparagraph (A), the Secretary determines that the device 
establishment is substantially not in compliance with this Act, the 
Secretary may, after notice and a written response, notify the 
establishment that the eligibility of the establishment for the 
inspections by accredited persons has been suspended.'';
            (F) in paragraph (6)(C)(ii), by striking ``in accordance 
        with section 510(h), or has not during such period been 
        inspected pursuant to section 510(i), as applicable'';
            (G) in paragraph (10)(B)(iii), by striking ``a reporting'' 
        and inserting ``a report''; and
            (H) in paragraph (12)--
                (i) by striking subparagraph (A) and inserting the 
            following:
        ``(A) the number of inspections conducted by accredited persons 
    pursuant to this subsection and the number of inspections conducted 
    by Federal employees pursuant to section 510(h) and of device 
    establishments required to register under section 510(i);''; and
                (ii) in subparagraph (E), by striking ``obtained by the 
            Secretary'' and all that follows and inserting ``obtained 
            by the Secretary pursuant to inspections conducted by 
            Federal employees;''.
        (2) Other corrections.--
            (A) Prohibited acts.--Section 301(gg) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as amended by 
        section 201(d) of Public Law 107-250 (116 Stat. 1609), is 
        amended to read as follows:
    ``(gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited under 
paragraph (2) of such section of false information in an inspection 
report under paragraph (7)(A) of such section; or the knowing failure 
of such a person to include material facts in such a report.''.
            (B) Electronic labeling.--Section 502(f) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as amended by 
        section 206 of Public Law 107-250 (116 Stat. 1613), is amended, 
        in the last sentence--
                (i) by inserting ``or by a health care professional and 
            required labeling for in vitro diagnostic devices intended 
            for use by health care professionals or in blood 
            establishments'' after ``in health care facilities'';
                (ii) by inserting a comma after ``means'';
                (iii) by striking ``requirements of law and, that'' and 
            inserting ``requirements of law, and that'';
                (iv) by striking ``the manufacturer affords health care 
            facilities the opportunity'' and inserting ``the 
            manufacturer affords such users the opportunity''; and
                (v) by striking ``the health care facility''.
    (c) Title III; Additional Amendments.--
        (1) Effective date.--Section 301(b) of Public Law 107-250 (116 
    Stat. 1616), is amended by striking ``18 months'' and inserting 
    ``36 months''.
        (2) Premarket notification.--Section 510(o) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by 
    section 302(b) of Public Law 107-250 (116 Stat. 1616), is amended--
            (A) in paragraph (1)(B), by striking ``, adulterated'' and 
        inserting ``or adulterated''; and
            (B) in paragraph (2)--
                (i) in subparagraph (B), by striking ``, adulterated'' 
            and inserting ``or adulterated''; and
                (ii) in subparagraph (E), by striking ``semicritical'' 
            and inserting ``semi-critical''.
    (d) Miscellaneous Corrections.--
        (1) Certain amendments to section 515.--
            (A) In general.--
                (i) Technical correction.--Section 515(c) of the 
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), 
            as amended by sections 209 and 302(c)(2)(A) of Public Law 
            107-250 (116 Stat. 1613, 1618), is amended by redesignating 
            paragraph (3) (as added by section 209 of such Public Law) 
            as paragraph (4).
                (ii) Modular review.--Section 515(c)(4)(B) of the 
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
            360e(c)(4)(B)) is amended by striking ``unless an issue of 
            safety'' and inserting ``unless a significant issue of 
            safety''.
            (B) Conforming amendment.--Section 210 of Public Law 107-
        250 (116 Stat. 1614) is amended by striking
        ``, as amended'' and all that follows through ``by adding'' and 
        inserting ``is amended in paragraph (3), as redesignated by 
        section 302(c)(2)(A) of this Act, by adding''.
        (2) Certain amendments to section 738.--
            (A) In general.--Section 738(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379j(a)), as amended by subsection 
        (a), is amended--
                (i) in the matter preceding paragraph (1)--

                    (I) by striking ``(a) Types of Fees.--Beginning 
                on'' and inserting the following:

    ``(a) Types of Fees.--
        ``(1) In general.--Beginning on''; and

                    (II) by striking ``this section as follows:'' and 
                inserting ``this section.''; and

                (ii) by striking ``(1) Premarket application,'' and 
            inserting the following: ``(2) Premarket application,''.
            (B) Conforming amendments.--Section 738 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by 
        subparagraph (A), is amended--
                (i) in subsection (d)(1), in the last sentence, by 
            striking ``subsection (a)(1)(A)'' and inserting 
            ``subsection (a)(2)(A)'';
                (ii) in subsection (e)(1), by striking ``subsection 
            (a)(1)(A)(vii)'' and inserting ``subsection 
            (a)(2)(A)(vii)'';
                (iii) in subsection (e)(2)(C)--

                    (I) in each of clauses (i) and (ii), by striking 
                ``subsection (a)(1)(A)(vii)'' and inserting 
                ``subsection (a)(2)(A)(vii)''; and
                    (II) in clause (ii), by striking ``subsection 
                (a)(1)(A)(i)'' and inserting ``subsection 
                (a)(2)(A)(i)''; and

                (iv) in subsection (j), by striking ``subsection 
            (a)(1)(D),'' and inserting ``subsection (a)(2)(D),''.
            (C) Additional conforming amendment.--Section 102(b)(1) of 
        Public Law 107-250 (116 Stat. 1600) is amended, in the matter 
        preceding subparagraph (A), by striking ``section 
        738(a)(1)(A)(ii)'' and inserting ``section 738(a)(2)(A)(ii)''.
        (3) Public law 107-250.--Public Law 107-250 is amended--
            (A) in section 102(a) (116 Stat. 1589), by striking ``(21 
        U.S.C. 379F et seq.)'' and inserting ``(21 U.S.C. 379f et 
        seq.)'';
            (B) in section 102(b) (116 Stat. 1600)--
                (i) by striking paragraph (2);
                (ii) in paragraph (1), by redesignating subparagraphs 
            (A) and (B) as paragraphs (1) and (2), respectively; and
                (iii) by striking:
    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--
        ``(1) In general.--A person submitting a premarket report'' and 
    inserting:
    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--A person submitting a premarket report''; and
            (C) in section 212(b)(2) (116 Stat. 1614), by striking ``, 
        such as phase IV trials,''.
SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR 
CHILDREN.
    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the barriers to the availability of devices intended for the 
treatment or diagnosis of diseases and conditions that affect children. 
The report shall include any recommendations of the Secretary of Health 
and Human Services for changes to existing statutory authority, 
regulations, or agency policy or practice to encourage the invention 
and development of such devices.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
Example Output: Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

Example Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patent Sovereignty Act of 1997''.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1) the quality of United States letters patent is 
        essential for preserving the technological lead and economic 
        well-being of the United States in the next century;
            (2) the quality of United States letters patent is highly 
        dependent upon the maintenance and the comprehensiveness of 
        patent examiners' search files; and
            (3) the quality of United States letters patent is 
        inextricably linked to the professionalism of patent examiners 
        and the quality of the training of patent examiners.

SEC. 3. SECURE PATENT EXAMINATION.

    Section 3 of title 35, United States Code, is amended by adding at 
the end thereof the following:
    ``(f) All examination and search duties for the grant of United 
States letters patent are sovereign functions which shall be performed 
within the United States by United States citizens who are employees of 
the United States Government.''.

SEC. 4. MAINTENANCE OF EXAMINERS' SEARCH FILES.

    Section 9 of title 35, United States Code, is amended--
            (1) by striking ``may revise and maintain'' and inserting 
        ``shall maintain and revise''; and
            (2) by adding at the end thereof the following: ``United 
        States letters patent, and all such other patents and printed 
        publications shall be maintained in the examiners' search files 
        under the United States Patent Classification System.''.

SEC. 5. PATENT EXAMINER TRAINING.

    (a) In General.--Chapter 1 of title 35, United States Code, is 
amended by adding at the end the following new section:
``Sec. 15. Patent examiner training
    ``(a) In General.--All patent examiners shall spend at least 5 
percent of their duty time per annum in training to maintain and 
develop the legal and technological skills useful for patent 
examination.
    ``(b) Trainers of Examiners.--The Patent and Trademark Office shall 
develop an incentive program to retain as employees patent examiners of 
the primary examiner grade or higher who are eligible for retirement, 
for the sole purpose of training patent examiners who have not achieved 
the grade of primary examiner.''.

SEC. 6. ADMINISTRATIVE MATTERS.

    (a) Limitations on Personnel.--Section 3(a) of title 35, United 
States Code, is amended by adding at the end thereof the following: 
``The Office shall not be subject to any administratively or 
statutorily imposed limitation on positions or personnel, and no 
positions or personnel of the Office shall be taken into account for 
purposes of applying any such limitation.''.
    (b) Retention of Fees.--(1) Section 255(g)(1)(A) of the Balanced 
Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 
905(g)(1)(A)) is amended by inserting after the item relating to the 
National Credit Union Administration, credit union share insurance 
fund, the following new item:
            ``Patent and Trademark Office''.
    (2) Section 10101(b)(2)(B) of the Omnibus Budget Reconciliation Act 
of 1990 (35 U.S.C. 41 note) is amended by striking ``, to the extent 
provided in appropriation Acts,'' and inserting ``without 
appropriation''.
    (3) Section 42(c) of title 35, United States Code, is amended by 
amending by striking first sentence and inserting the following: 
``Revenues from fees shall be available to the Commissioner to carry 
out the activities of the Patent and Trademark Office, in such 
allocations as are approved by Act of Congress. Such revenues shall not 
be made available for any purpose other than that authorized for the 
Patent and Trademark Office.''.
    (c) Compensation of Commissioner.--(1) Section 5314 of title 5, 
United States Code, is amended by adding at the end the following:
            ``Under Secretary of Commerce and Commissioner of Patents 
        and Trademarks.''.
    (2) Section 3(d) of title 35, United States Code, is amended to 
read as follows:
    ``(d) The Commissioner of Patents and Trademarks shall be an Under 
Secretary of Commerce.''.
    (3) Section 5316 of title 5, United States Code, is amended by 
striking ``Commissioner of Patents, Department of Commerce.''.
    (d) Use of Fees.--Section 42(c) of title 35, United States Code, is 
amended by adding at the end thereof the following: ``All patent 
application fees collected under paragraphs (1), (3)(A), (3)(B), and 
(4) through (8) of section 41(a), and all other fees collected under 
section 41 for services or the extension of services to be provided by 
patent examiners shall be used only for the pay and training of patent 
examiners.''.
    (e) Publications.--Section 11 of title 35, United States Code, is 
amended by adding at the end thereof the following:
    ``(c) The Patent and Trademark Office shall make available for 
public inspection during regular business hours all solicitations 
issued by the Office for contracts for goods or services, and all 
contracts for goods or services entered into by the Office.
    ``(d) Notice of a proposal to change United States patent law that 
will be made on behalf of the United States to a foreign country or 
international body shall be published in the Federal Register before, 
or at the same time as, the proposal is transmitted.''.

SEC. 7. EFFECTIVE DATE.

    This Act shall take effect 30 days after the date of the enactment 
of this Act.
Example Output:
Patent Sovereignty Act of 1997 - Amends Federal patent law to declare all examination and search duties for the grant of U.S. letters patent to be sovereign functions which shall be performed within the United States by U.S. citizens who are Government employees. 
Requires (current law authorizes) the Commissioner of Patents and Trademarks to revise and maintain the classification by subject matter of all U.S. letters patent.  Requires such patents, and all such other patents and printed publications, to be maintained in the examiners' search files under the U.S. Patent Classification System. 
Requires all patent examiners to spend at least five percent of their annual duty time in training to maintain and develop legal and technical skills useful for patent examination.  Directs the Patent and Trademark Office (Office) to develop an incentive program to retain patent examiners of primary examiner grade or higher to train other patent examiners who have not achieved such grade. 
Prohibits the Office from being subject to any administratively or statutorily imposed limitations on positions or personnel.  Allows patent fees to be retained by the Office to carry out its activities, including the training of patent examiners, in such allocations as approved by the Congress.  Requires the Office to make public all Office solicitations for goods and services, as well as all such contracts entered into by the Office.  Requires publication in the Federal Register of notice of a proposal to change U.S. patent law that will be made on behalf of the United States to a foreign country or international body.