instruction:
In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
question:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Federal Activities Inventory Reform 
Act of 1998''.
SEC. 2. ANNUAL LISTS OF GOVERNMENT ACTIVITIES NOT INHERENTLY 
GOVERNMENTAL IN NATURE.
    (a) Lists Required.--Not later than the end of the third quarter of 
each fiscal year, the head of each executive agency shall submit to the 
Director of the Office of Management and Budget a list of activities 
performed by Federal Government sources for the executive agency that, 
in the judgment of the head of the executive agency, are not inherently 
governmental functions. The entry for an activity on the list shall 
include the following:
        (1) The fiscal year for which the activity first appeared on a 
    list prepared under this section.
        (2) The number of full-time employees (or its equivalent) that 
    are necessary for the performance of the activity by a Federal 
    Government source.
        (3) The name of a Federal Government employee responsible for 
    the activity from whom additional information about the activity 
    may be obtained.
    (b) OMB Review and Consultation.--The Director of the Office of 
Management and Budget shall review the executive agency's list for a 
fiscal year and consult with the head of the executive agency regarding 
the content of the final list for that fiscal year.
    (c) Public Availability of Lists.--
        (1) Publication.--Upon the completion of the review and 
    consultation regarding a list of an executive agency--
            (A) the head of the executive agency shall promptly 
        transmit a copy of the list to Congress and make the list 
        available to the public; and
            (B) the Director of the Office of Management and Budget 
        shall promptly publish in the Federal Register a notice that 
        the list is available to the public.
        (2) Changes.--If the list changes after the publication of the 
    notice as a result of the resolution of a challenge under section 
    3, the head of the executive agency shall promptly--
            (A) make each such change available to the public and 
        transmit a copy of the change to Congress; and
            (B) publish in the Federal Register a notice that the 
        change is available to the public.
    (d) Competition Required.--Within a reasonable time after the date 
on which a notice of the public availability of a list is published 
under subsection (c), the head of the executive agency concerned shall 
review the activities on the list. Each time that the head of the 
executive agency considers contracting with a private sector source for 
the performance of such an activity, the head of the executive agency 
shall use a competitive process to select the source (except as may 
otherwise be provided in a law other than this Act, an Executive order, 
regulations, or any executive branch circular setting forth 
requirements or guidance that is issued by competent executive 
authority). The Director of the Office of Management and Budget shall 
issue guidance for the administration of this subsection.
    (e) Realistic and Fair Cost Comparisons.--For the purpose of 
determining whether to contract with a source in the private sector for 
the performance of an executive agency activity on the list on the 
basis of a comparison of the costs of procuring services from such a 
source with the costs of performing that activity by the executive 
agency, the head of the executive agency shall ensure that all costs 
(including the costs of quality assurance, technical monitoring of the 
performance of such function, liability insurance, employee retirement 
and disability benefits, and all other overhead costs) are considered 
and that the costs considered are realistic and fair.

SEC. 3. CHALLENGES TO THE LIST.

    (a) Challenge Authorized.--An interested party may submit to an 
executive agency a challenge of an omission of a particular activity 
from, or an inclusion of a particular activity on, a list for which a 
notice of public availability has been published under section 2.
    (b) Interested Party Defined.--For the purposes of this section, 
the term ``interested party'', with respect to an activity referred to 
in subsection (a), means the following:
        (1) A private sector source that--
            (A) is an actual or prospective offeror for any contract, 
        or other form of agreement, to perform the activity; and
            (B) has a direct economic interest in performing the 
        activity that would be adversely affected by a determination 
        not to procure the performance of the activity from a private 
        sector source.
        (2) A representative of any business or professional 
    association that includes within its membership private sector 
    sources referred to in paragraph (1).
        (3) An officer or employee of an organization within an 
    executive agency that is an actual or prospective offeror to 
    perform the activity.
        (4) The head of any labor organization referred to in section 
    7103(a)(4) of title 5, United States Code, that includes within its 
    membership officers or employees of an organization referred to in 
    paragraph (3).
    (c) Time for Submission.--A challenge to a list shall be submitted 
to the executive agency concerned within 30 days after the publication 
of the notice of the public availability of the list under section 2.
    (d) Initial Decision.--Within 28 days after an executive agency 
receives a challenge, an official designated by the head of the 
executive agency shall--
        (1) decide the challenge; and
        (2) transmit to the party submitting the challenge a written 
    notification of the decision together with a discussion of the 
    rationale for the decision and an explanation of the party's right 
    to appeal under subsection (e).
    (e) Appeal.--
        (1) Authorization of appeal.--An interested party may appeal an 
    adverse decision of the official to the head of the executive 
    agency within 10 days after receiving a notification of the 
    decision under subsection (d).
        (2) Decision on appeal.--Within 10 days after the head of an 
    executive agency receives an appeal of a decision under paragraph 
    (1), the head of the executive agency shall decide the appeal and 
    transmit to the party submitting the appeal a written notification 
    of the decision together with a discussion of the rationale for the 
    decision.

SEC. 4. APPLICABILITY.

    (a) Executive Agencies Covered.--Except as provided in subsection 
(b), this Act applies to the following executive agencies:
        (1) Executive department.--An executive department named in 
    section 101 of title 5, United States Code.
        (2) Military department.--A military department named in 
    section 102 of title 5, United States Code.
        (3) Independent establishment.--An independent establishment, 
    as defined in section 104 of title 5, United States Code.
    (b) Exceptions.--This Act does not apply to or with respect to the 
following:
        (1) General accounting office.--The General Accounting Office.
        (2) Government corporation.--A Government corporation or a 
    Government controlled corporation, as those terms are defined in 
    section 103 of title 5, United States Code.
        (3) Nonappropriated funds instrumentality.--A part of a 
    department or agency if all of the employees of that part of the 
    department or agency are employees referred to in section 2105(c) 
    of title 5, United States Code.
        (4) Certain depot-level maintenance and repair.--Depot-level 
    maintenance and repair of the Department of Defense (as defined in 
    section 2460 of title 10, United States Code).

SEC. 5. DEFINITIONS.

    In this Act:
        (1) Federal government source.--The term ``Federal Government 
    source'', with respect to performance of an activity, means any 
    organization within an executive agency that uses Federal 
    Government employees to perform the activity.
        (2) Inherently governmental function.--
            (A) Definition.--The term ``inherently governmental 
        function'' means a function that is so intimately related to 
        the public interest as to require performance by Federal 
        Government employees.
            (B) Functions included.--The term includes activities that 
        require either the exercise of discretion in applying Federal 
        Government authority or the making of value judgments in making 
        decisions for the Federal Government, including judgments 
        relating to monetary transactions and entitlements. An 
        inherently governmental function involves, among other things, 
        the interpretation and execution of the laws of the United 
        States so as--
                (i) to bind the United States to take or not to take 
            some action by contract, policy, regulation, authorization, 
            order, or otherwise;
                (ii) to determine, protect, and advance United States 
            economic, political, territorial, property, or other 
            interests by military or diplomatic action, civil or 
            criminal judicial proceedings, contract management, or 
            otherwise;
                (iii) to significantly affect the life, liberty, or 
            property of private persons;
                (iv) to commission, appoint, direct, or control 
            officers or employees of the United States; or
                (v) to exert ultimate control over the acquisition, 
            use, or disposition of the property, real or personal, 
            tangible or intangible, of the United States, including the 
            collection, control, or disbursement of appropriated and 
            other Federal funds.
            (C) Functions excluded.--The term does not normally 
        include--
                (i) gathering information for or providing advice, 
            opinions, recommendations, or ideas to Federal Government 
            officials; or
                (ii) any function that is primarily ministerial and 
            internal in nature (such as building security, mail 
            operations, operation of cafeterias, housekeeping, 
            facilities operations and maintenance, warehouse 
            operations, motor vehicle fleet management operations, or 
            other routine electrical or mechanical services).

SEC. 6. EFFECTIVE DATE.

    This Act shall take effect on October 1, 1998.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
answer:
Federal Activities Inventory Reform Act of 1998 - Directs the head of each executive agency to submit to the Director of the Office of Management and Budget, not later than the end of the third quarter of each fiscal year, a list of activities performed by Federal Government sources for the agency that, in the judgment of the head of the executive agency, are not inherently governmental functions. 
Requires:  (1) the Director to review the agency's list and consult with the agency head regarding the contents of the final list for the fiscal year; (2) the agency head to transmit a copy of the list to the Congress and make the list publicly available; (3) the Director to publish in the Federal Register a notice that the list is publicly available; and (4) the agency head to publish a notice regarding, make available to the public, and transmit to the Congress, any subsequent change to the list. 
Requires the agency head to:  (1) review the activities on the list within a reasonable time after such a notice of its availability is published; and (2) use a competitive process (with specified exceptions) and ensure that all costs are considered each time that he or she considers contracting with a private sector source for the performance of an activity on the list. 
(Sec. 3) Permits an interested party to submit to an agency a challenge of an omission of a particular activity from, or an inclusion of a particular activity on, a list for which a notice has been published.  Sets forth procedures governing filing challenges, agency decisions on challenges, appealing such decisions, and agency decisions on such appeals. 
(Sec. 4) Provides that this Act shall not apply to or with respect to:  (1) the General Accounting Office; (2) Government corporations and Government controlled corporations; (3) a part of a department or agency if all of the employees of that part are employees paid from nonappropriated funds of certain instrumentalities of the United States under the jurisdiction of the armed forces; and (4) depot-level maintenance and repair of the Department of Defense.


question:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Skilled Workforce Enhancement Act of 
2001''.

SEC. 2. CREDIT FOR EXPENSES FOR LONG-TERM TRAINING OF EMPLOYEES IN 
              HIGHLY SKILLED SMALL BUSINESS TRADES.

    (a) In General.--Subpart D of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 (relating to business-related 
credits) is amended by adding at the end the following new section:

``SEC. 45E. EXPENSES FOR LONG-TERM TRAINING OF EMPLOYEES IN HIGHLY 
              SKILLED SMALL BUSINESS TRADES.

    ``(a) General Rule.--For purposes of section 38, in the case of a 
small business employer, the highly skilled trades training credit 
determined under this section for the taxable year is $15,000 for each 
employee having a qualified training year ending with or within such 
taxable year (whether or not such employee is an employee of the 
taxpayer as of the close of such taxable year).
    ``(b) Definitions.--For purposes of this section--
            ``(1) Small business employer.--
                    ``(A) In general.--The term `small business 
                employer' means, with respect to any taxable year, any 
                employer who employed an average of 250 or fewer 
                employees on business days during such taxable year.
                    ``(B) Controlled groups.--For purposes of 
                subparagraph (A), all persons treated as a single 
                employer under subsection (b), (c), (m), or (o) of 
                section 414 shall be treated as a single employer.
            ``(2) Qualified training year.--
                    ``(A) In general.--The term `qualified training 
                year' means each year during the training period in 
                which the employee received at least 1,500 hours of 
                training (including on-the-job training and training at 
                multi-employer training facilities) from the taxpayer 
                (or any predecessor) under a qualified training program 
                as an apprentice in any highly skilled trade.
                    ``(B) Highly skilled trades.--For purposes of 
                subparagraph (A), the term `highly skilled trades' 
                means--
                            ``(i) precision machinists,
                            ``(ii) die makers,
                            ``(iii) mold makers,
                            ``(iv) tool and die designers,
                            ``(v) heating, ventilating, air 
                        conditioning, refrigeration, and roofing 
                        contractors,
                            ``(vi) the trade of masonry,
                            ``(vii) plumbers,
                            ``(viii) pipefitters,
                            ``(ix) patternmakers,
                            ``(x) foundry technicians,
                            ``(xi) electricians,
                            ``(xii) recreational marine production and 
                        design workers,
                            ``(xiii) 2-way radio technicians,
                            ``(xiv) welders,
                            ``(xv) shipfitters,
                            ``(xvi) propellor machinists,
                            ``(xvii) electronic instrumentation 
                        specialists, and
                            ``(xviii) other highly skilled trades 
                        specified in regulations prescribed by the 
                        Secretary.
                Such term shall not include any trade if the customary 
                apprenticeship period for such trade is less than 2 
                years.
                    ``(C) Qualified training program.--
                            ``(i) In general.--The term `qualified 
                        training program' means a written plan of study 
                        and training for individuals in, or entering 
                        into, highly skilled trades.
                            ``(ii) Description of programs.--A plan 
                        under clause (i) must be a program described in 
                        one of the following subclauses:
                                    ``(I) An apprenticeship program 
                                registered and certified with the 
                                Secretary of Labor under section 1 of 
                                the National Apprenticeship Act (29 
                                U.S.C. 50).
                                    ``(II) A program licensed, 
                                registered, or certified by the 
                                workforce investment board or 
                                apprenticeship agency or council of a 
                                State or administered in compliance 
                                with apprenticeship laws of a State.
                                    ``(III) A program conducted by a 
                                vocational or technical education 
                                school, community college, or 
                                industrial or trade training 
                                organization.
                                    ``(IV) A program which conforms to 
                                apprentice training programs developed 
                                or administered by an employer trade 
                                group or committee.
                                    ``(V) An industry sponsored or 
                                administered program which is clearly 
                                identified and commonly 
recognized within an industry and which meets the requirements of 
clause (iii).
                            ``(iii) Requirements.--A program meets the 
                        requirements of this clause if such program--
                                    ``(I) is accessible to individuals 
                                without discrimination on the basis of 
                                race, sex, color, religion, or national 
                                origin,
                                    ``(II) provides an overview of the 
                                trade, including the history and modern 
                                developments in such trade,
                                    ``(III) provides related 
                                instruction of the fundamental, 
                                intermediate, and advanced skills, 
                                techniques, and materials of the trade,
                                    ``(IV) provides training in math, 
                                measurement, and blueprint reading 
                                skills, if such skills are required in 
                                the trade,
                                    ``(V) provides training on trade 
                                specific tools and equipment,
                                    ``(VI) provides on-the-job training 
                                which allows performance of work under 
                                close supervision of an instructor or 
                                skilled worker, and
                                    ``(VII) provides periodic review 
                                and evaluation of participants to 
                                demonstrate proficiency in skills, 
                                including the use of tests and 
                                assessment of individual and group 
                                projects.
            ``(3) Training period.--The term `training period' means, 
        with respect to an employee, the period--
                    ``(A) beginning on the date that the employee 
                begins employment with the taxpayer as an apprentice in 
                the highly skilled trade, and
                    ``(B) ending on the earlier of--
                            ``(i) the date that such apprenticeship 
                        with the employer ends, or
                            ``(ii) the date which is 4 years after the 
                        date referred to in subparagraph (A).
    ``(c) Coordination With Other Credits.--The amount of credit 
otherwise allowable under sections 51(a) and 1396(a) with respect to 
any employee shall be reduced by the credit allowed by this section 
with respect to such employee.''.
    (b) Credit Made Part of General Business Credit.--Subsection (b) of 
section 38 of such Code is amended by striking ``plus'' at the end of 
paragraph (12), by striking the period at the end of paragraph (13) and 
inserting ``, plus'', and by adding at the end the following new 
paragraph:
            ``(14) in the case of a small business employer (as defined 
        in section 45E(b)), the highly skilled trades training credit 
        determined under section 45E(a).''.
    (c) Denial of Double Benefit.--Section 280C of such Code is amended 
by adding at the end the following new subsection:
    ``(d) Credit for Training Expenses for Employees in Highly Skilled 
Small Business Trades.--No deduction shall be allowed for that portion 
of the expenses otherwise allowable as a deduction for the taxable year 
which is equal to the amount of the credit determined for the taxable 
year under section 45E(a).''.
    (d) Clerical Amendment.--The table of sections for subpart D of 
part IV of subchapter A of chapter 1 of such Code is amended by adding 
at the end the following new item:

                              ``Sec. 45E. Expenses for long-term 
                                        training of employees in highly 
                                        skilled small business 
                                        trades.''.
    (e) Effective Date.--The amendments made by this section shall 
apply to expenses paid or incurred in the taxable years ending after 
the date of the enactment of this Act.
answer:
Skilled Workforce Enhancement Act of 2001 - Amends the Internal Revenue Code to provide small employers with a highly skilled trades training credit.


question:
SECTION 1. PEDIATRIC LABELING OF DRUGS AND BIOLOGICAL PRODUCTS.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 505A the following:

``SEC. 505B. PEDIATRIC LABELING OF DRUGS AND BIOLOGICAL PRODUCTS.

    ``(a) New Drugs and Biological Products.--
            ``(1) In general.--A person that submits an application (or 
        supplement to an application)--
                    ``(A) under section 505 for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration; or
                    ``(B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a biological product 
                license;
        shall submit with the application the assessments described in 
        paragraph (2).
            ``(2) Assessments.--
                    ``(A) In general.--The assessments referred to in 
                paragraph (1) shall contain data, gathered using 
                appropriate formulations, that are adequate--
                            ``(i) to assess the safety and 
                        effectiveness of the drug, or the biological 
                        product licensed under section 351 of the 
                        Public Health Service Act (42 U.S.C. 262), for 
                        the claimed indications in all relevant 
                        pediatric subpopulations; and
                            ``(ii) to support dosing and administration 
                        for each pediatric subpopulation for which the 
                        drug, or the biological product licensed under 
                        section 351 of the Public Health Service Act 
                        (42 U.S.C. 262), is safe and effective.
                    ``(B) Similar course of disease or similar effect 
                of drug or biological product.--If the course of the 
                disease and the effects of the drug are sufficiently 
                similar in adults and pediatric patients, the Secretary 
                may conclude that pediatric effectiveness can be 
                extrapolated from adequate and well-controlled studies 
                in adults, usually supplemented with other information 
                obtained in pediatric patients, such as pharmacokinetic 
                studies.
            ``(3) Deferral.--On the initiative of the Secretary or at 
        the request of the applicant, the Secretary may defer 
        submission of some or all assessments required under paragraph 
        (1) until a specified date after approval of the drug or 
        issuance of the license for a biological product if--
                    ``(A) the Secretary finds that--
                            ``(i) the drug or biological product is 
                        ready for approval for use in adults before 
                        pediatric studies are complete; or
                            ``(ii) pediatric studies should be delayed 
                        until additional safety or effectiveness data 
                        have been collected; and
                    ``(B) the applicant submits to the Secretary--
                            ``(i) a certified description of the 
                        planned or ongoing studies; and
                            ``(ii) evidence that the studies are being 
                        conducted or will be conducted with due 
                        diligence.
            ``(4) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if--
                            ``(i) necessary studies are impossible or 
                        highly impractical;
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups; or
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients; and
                                    ``(II) is not likely to be used in 
                                a substantial number of pediatric 
                                patients.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if--
                            ``(i) necessary studies are impossible or 
                        highly impractical;
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
patients in that age group; and
                                    ``(II) is not likely to be used in 
                                a substantial number of pediatric 
                                patients in that age group; or
                            ``(iv) the applicant demonstrates that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
    ``(b) Marketed Drugs and Biological Products.--
            ``(1) In general.--After providing notice and an 
        opportunity for written response and a meeting, which may 
        include an advisory committee meeting, the Secretary may by 
        order require the holder of an approved application relating to 
        a drug under section 505 or the holder of a license for a 
        biological product under section 351 of the Public Health 
        Service Act (42 U.S.C. 262) to submit by a specified date the 
        assessments described in subsection (a) if the Secretary finds 
        that--
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients for the 
                labeled indications; and
                    ``(ii) the absence of adequate labeling could pose 
                significant risks to pediatric patients; or
                    ``(B)(i) there is reason to believe that the drug 
                or biological product would represent a meaningful 
                therapeutic benefit over existing therapies for 
                pediatric patients for 1 or more of the claimed 
                indications; and
                    ``(ii) the absence of adequate labeling could pose 
                significant risks to pediatric patients.
            ``(2) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if--
                            ``(i) necessary studies are impossible or 
                        highly impractical; or
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if--
                            ``(i) necessary studies are impossible or 
                        highly impractical;
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii)(I) the drug or biological product 
                        does not represent a meaningful therapeutic 
                        benefit over existing therapies for pediatric 
                        patients in that age group;
                            ``(II) the drug or biological product is 
                        not likely to be used in a substantial number 
                        of pediatric patients in that age group; and
                            ``(III) the absence of adequate labeling 
                        could not pose significant risks to pediatric 
                        patients; or
                            ``(iv) the applicant demonstrates that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
            ``(3) Relationship to other pediatric provisions.--
                    ``(A) No assessment without written request.--No 
                assessment may be required under paragraph (1) for a 
                drug subject to an approved application under section 
                505 unless--
                            ``(i) the Secretary has issued a written 
                        request for related pediatric studies under 
                        section 505A(d) or section 409I of the Public 
                        Health Service Act; and
                            ``(ii)(I) if the request was made under 
                        section 505A(d)--
                                    ``(aa) the recipient of the written 
                                request does not agree to the request; 
                                or
                                    ``(bb) the Secretary does not 
                                receive a response as specified under 
                                section 505A(d)(4)(A); or
                            ``(II) if the request was made under 
                        section 409I of the Public Health Service Act--
                                    ``(aa) the recipient of the written 
                                request does not agree to the request; 
                                or
                                    ``(bb) the Secretary does not 
                                receive a response as specified under 
                                section 409I(c)(2) of that Act.
                    ``(B) No effect on other authority.--Nothing in 
                this subsection shall be construed to alter any 
                requirement under section 505A(d)(4) or section 409I of 
                the Public Health Service Act. Subject to paragraph 
                (2)(A), nothing in this subsection, section 505A(d)(4), 
                or section 409I or 499 of the Public Health Service Act 
                shall be construed to preclude the Secretary from 
                exercising the authority of the Secretary under this 
                subsection.
    ``(c) Delay in Submission of Assessments.--If a person delays the 
submission of assessments relating to a drug or biological product 
beyond a date specified in subsection (a) or (b)--
            ``(1) the drug or biological product--
                    ``(A) may be considered by the Secretary to be 
                misbranded and subject to action under sections 302 and 
                304; and
                    ``(B) shall not be subject to action under section 
                303; and
            ``(2) the delay shall not be the basis for a proceeding to 
        withdraw approval for a drug under section 505(e) or revoke the 
        license for a biological product under section 351 of the 
        Public Health Service Act (42 U.S.C. 262).
    ``(d) Meetings.--The Secretary shall meet at appropriate times in 
the investigational new drug process with the sponsor to discuss 
background information that the sponsor shall submit on plans and 
timelines for pediatric studies, or any planned request for waiver or 
deferral of pediatric studies.''.
    (b) Conforming Amendments.--
            (1) Section 505(b)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(b)(1)) is amended in the second 
        sentence--
                    (A) by striking ``and (F)'' and inserting ``(F)''; 
                and
                    (B) by striking the period at the end and inserting 
                ``, and (G) any assessments required under section 
                505B.''.
            (2) Section 505A(h) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355a(h)) is amended--
                    (A) in the subsection heading, by striking 
                ``Regulations'' and inserting ``Pediatric Study 
                Requirements''; and
                    (B) by striking ``pursuant to regulations 
                promulgated by the Secretary'' and inserting ``by a 
                provision of law (including a regulation) other than 
                this section''.
            (3) Section 351(a)(2) of the Public Health Service Act (42 
        U.S.C. 262(a)(2)) is amended--
                    (A) by redesignating subparagraph (B) as 
                subparagraph (C); and
                    (B) by inserting after subparagraph (A) the 
                following:
                    ``(B) Pediatric studies.--A person that submits an 
                application for a license under this paragraph shall 
                submit to the Secretary as part of the application any 
                assessments required under section 505B of the Federal 
                Food, Drug, and Cosmetic Act.''.
    (c) Final Rule.--Except to the extent that the final rule is 
inconsistent with the amendment made by subsection (a), the final rule 
promulgating regulations requiring manufacturers to assess the safety 
and effectiveness of new drugs and biological products in pediatric 
patients (63 Fed. Reg. 66632 (December 2, 1998)), shall be considered 
to implement the amendment made by subsection (a).
    (d) No Effect on Authority.--Section 505B of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a)) does not affect 
whatever existing authority the Secretary of Health and Human Services 
has to require pediatric assessments regarding the safety and efficacy 
of drugs and biological products in addition to the assessments 
required under that section. The authority, if any, of the Secretary of 
Health and Human Services regarding specific populations other than the 
pediatric population shall be exercised in accordance with the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on 
the day before the date of enactment of this Act.

SEC. 2. TECHNICAL CORRECTION.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended in subparagraphs (A) and (B) of subsection (b)(2) and 
subparagraphs (A) and (B) of subsection (c)(2) by striking 
``505(j)(4)(B)'' and inserting ``505(j)(5)(B)''.
answer:

Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage.Permits extrapolation from adult studies where the course of the disease and the effects of the drug are sufficiently similar in all populations.Permits deferral of such assessments if adult studies are completed earlier and the applicant submits a plan for or a description of planned or ongoing pediatric studies.Permits full waiver of such assessments if: (1) studies are highly impractical or impossible; (2) the evidence strongly suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; (3) there is no meaningful therapeutic advantage or benefit in the pediatric population; or (4) the drug or product is not likely to be used in a substantial number of pediatric patients.Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed.Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations.Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if: (1) the drug or biological product would represent a meaningful therapeutic benefit for pediatric patients for one or more claimed indications and the absence of adequate labeling could pose significant risks to pediatric patients; or (2) it is used for a number of pediatric patients for the labeled indications and the absence of adequate labeling could pose significant risks to pediatric patients. Sets forth criteria for full waiver and partial waivers of such requirement. Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations.Requires the Secretary to issue a written request for related pediatric studies under the Public Health Service Act before requiring an assessment for a drug.States that drugs or products with delayed assessments may be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties.