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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Teacher and Nurse Support Act of 
2007''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds the following:
            (1) According to the National Center for Education 
        Statistics, over the next 10 years, the United States will need 
        more than 2,000,000 new teachers to replace the teachers who 
        are retiring or leaving the classroom for other careers.
            (2) The Hart-Rudman National Security Report on education 
        recommended that the President direct the Department of 
        Education to work with the States to devise a comprehensive 
        plan to avert a looming shortage of high-quality teachers.
            (3) According to the National Center for Education 
        Statistics, 20 percent of all new teachers leave the teaching 
        profession within 3 years. Providing loan forgiveness or loan 
        cancellation is one step that would help retain high-quality 
        teachers in schools that need teachers.
            (4) The American Hospital Association has reported more 
        than 118,000 unfilled registered nurse positions in hospitals 
        in the United States. Additionally, the National Commission on 
        Nursing Workforce for Long-Term Care released a report in May, 
        2005, stating that there are nearly 100,000 vacant nursing 
        positions in long-term care facilities on any given day, and 
        the nurse turnover rate exceeds 50 percent. The shortage is 
        costing long-term care facilities an estimated $4 billion a 
        year in recruitment and training expenses.
            (5) College loans are more of a burden than ever for 
        students and families. According to a recent United States 
        Public Interest Research Group report, average student loan 
        debt almost doubled from $9,200 in 1992-1993 to $16,928 in 
        1999-2000.
    (b) Purpose.--The purpose of this Act is to improve access to, and 
the delivery of, high-quality educational and health services 
throughout the United States by reducing the shortage of qualified 
teachers and nurses.

SEC. 3. LOAN FORGIVENESS.

    (a) Loan Forgiveness.--Section 428J of the Higher Education Act of 
1965 (20 U.S.C. 1078-10) is amended to read as follows:

``SEC. 428J. LOAN FORGIVENESS FOR TEACHERS AND NURSES.

    ``(a) Statement of Purpose.--It is the purpose of this section to 
encourage individuals to enter and continue in the teaching and nursing 
professions.
    ``(b) Program Authorized.--
            ``(1) In general.--The Secretary shall carry out a program 
        to forgive, in accordance with this section, the student loan 
        debt of any borrower who has one or more loans described under 
        paragraph (2) made on or after October 1, 1998, and who--
                    ``(A) has been employed--
                            ``(i) as a full-time teacher--
                                    ``(I) in a school that qualifies 
                                under section 465(a)(2)(A) for loan 
                                cancellation for Perkins loan 
                                recipients who teach in those schools;
                                    ``(II) if employed as a secondary 
                                school teacher, is teaching a subject 
                                area that is relevant to the borrower's 
                                academic major as certified by the 
                                chief administrative officer of the 
                                public or nonprofit private secondary 
                                school in which the borrower is 
                                employed; and
                                    ``(III) if employed as an 
                                elementary school teacher, has 
                                demonstrated, as certified by the chief 
                                administrative officer of the public or 
                                nonprofit private elementary school in 
                                which the borrower is employed, 
                                knowledge and teaching skills in 
                                reading, writing, mathematics, and 
                                other areas of the elementary school 
                                curriculum; or
                            ``(ii) as a full-time eligible nurse--
                                    ``(I) in a clinical setting; or
                                    ``(II) as a member of the nursing 
                                faculty at an accredited school of 
                                nursing (as those terms are defined in 
                                section 801 of the Public Health 
                                Service Act (42 U.S.C. 296)); and
                    ``(B) is not in default on a loan for which the 
                borrower seeks forgiveness.
            ``(2) Method of loan forgiveness.--To provide the loan 
        forgiveness authorized in paragraph (1), the Secretary shall, 
        subject to paragraph (3), carry out a program--
                    ``(A) through the holder of the loan, to assume the 
                obligation to repay a qualified loan amount (as 
                determined under subsection (c)) for a loan made under 
                section 428 or 428H of this part; and
                    ``(B) to cancel a qualified loan amount (as so 
                determined) for a Federal Direct Stafford Loan or a 
                Federal Direct Unsubsidized Stafford Loan made under 
                part D of this title;
            ``(3) Treatment of consolidation loans.--A loan amount for 
        a loan made under section 428C or section 455(g) may be a 
        qualified loan amount for the purposes of paragraph (2) only to 
        the extent that such loan amount was used to repay a loan made 
        under section 428 or 428H, a Federal Direct Stafford Loan, or a 
        Federal Direct Unsubsidized Stafford Loan for a borrower who 
        meets the requirements of paragraph (1), as determined in 
        accordance with regulations prescribed by the Secretary.
    ``(c) Qualified Loan Amount.--
            ``(1) In general.--
                    ``(A) Aggregate amount.--The Secretary shall, in 
                installments in accordance with subparagraph (B), 
                forgive under this section not more than $17,500 in the 
                aggregate of the student loan obligation of a borrower.
                    ``(B) Annual installments.--The Secretary shall 
                forgive the student loan obligation of a borrower in 
                annual installments after each of 5 years of service 
                described in clause (i) or (ii) of subsection 
                (b)(1)(A)(i) in an amount not to exceed the lesser of 
                the remaining outstanding obligation of the borrower 
                or--
                            ``(i) $2,000 at the completion of the first 
                        year of such service;
                            ``(ii) $2,500 at the completion of the 
                        second year of such service;
                            ``(iii) $3,500 at the completion of the 
                        third year of such service;
                            ``(iv) $4,500 at the completion of the 
                        fourth year of such service; and
                            ``(v) $5,000 at the completion of the fifth 
                        year of such service.
            ``(2) Forbearance on qualified loan amount.--A holder of a 
        loan on which a borrower is seeking forgiveness under this 
        section--
                    ``(A) shall grant forbearance, at the request of 
                the borrower, in annual increments for each of the 
                years of qualifying service if the holder believes, at 
                the time of the borrower's annual request, that the 
                amount expected to be forgiven under this section at 
                the completion of the period of qualifying service will 
                satisfy the anticipated remaining outstanding balance 
                on the loan; and
                    ``(B) may offer other forbearance options to the 
                borrower.
    ``(d) Regulations.--The Secretary is authorized to issue such 
regulations as may be necessary to carry out the provisions of this 
section.
    ``(e) Construction.--Nothing in this section shall be construed to 
authorize any refunding of any repayment of a loan.
    ``(f) List of Schools.--If the list of schools in which a teacher 
may perform service pursuant to subsection (b)(1)(A)(i) is not 
available before May 1 of any year, the Secretary may use the list for 
the year preceding the year for which the determination is made to make 
the service determination.
    ``(g) Additional Eligibility Provisions.--
            ``(1) Continued eligibility for teachers.--Any teacher who 
        performs service in a school that--
                    ``(A) meets the requirements of subsection 
                (b)(1)(A)(i)(I) in any year during such service; and
                    ``(B) in a subsequent year fails to meet the 
                requirements of that subsection,
        may continue to teach in the school and shall be eligible for 
        loan forgiveness pursuant to subsection (b).
            ``(2) Prevention of double benefits.--No borrower may, for 
        the same service, receive a benefit under both this subsection 
        and--
                    ``(A) subtitle D of title I of the National and 
                Community Service Act of 1990 (42 U.S.C. 12571 et 
                seq.); or
                    ``(B) section 846 of the Public Health Service Act 
                (42 U.S.C. 297n).
    ``(h) Definitions.--In this section:
            ``(1) Eligible nurse.--The term `eligible nurse' means a 
        nurse who meets all of the following:
                    ``(A) The nurse graduated from--
                            ``(i) an accredited school of nursing (as 
                        those terms are defined in section 801 of the 
                        Public Health Service Act (42 U.S.C. 296));
                            ``(ii) a nursing center; or
                            ``(iii) an academic health center that 
                        provides nurse training.
                    ``(B) The nurse holds a valid and unrestricted 
                license to practice nursing in the State in which the 
                nurse practices in a clinical setting.
                    ``(C) The nurse holds 1 or more of the following:
                            ``(i) A graduate degree in nursing or 
                        equivalent degree.
                            ``(ii) A nursing degree from a collegiate 
                        school of nursing (as defined in section 801 of 
                        the Public Health Service Act (42 U.S.C. 296)).
                            ``(iii) A nursing degree from an associate 
                        degree school of nursing (as defined in section 
                        801 of the Public Health Service Act (42 U.S.C. 
                        296)).
                            ``(iv) A nursing degree from a diploma 
                        school of nursing (as defined in section 801 of 
                        the Public Health Service Act (42 U.S.C. 296)).
            ``(2) Year.--The term `year', where applied to service as a 
        teacher (or service as a member of the nursing faculty at an 
        accredited school of nursing (as those terms are defined in 
        section 801 of the Public Health Service Act (42 U.S.C. 296))), 
        means an academic year as defined by the Secretary.''.
    (b) Repeal of Loan Cancellation Provision.--Section 460 of the 
Higher Education Act of 1965 (20 U.S.C. 1087j) is repealed.

SEC. 4. PHASE OUT OF CURRENT PROGRAM.

    An individual who began the required period of teaching described 
in section 428J(b)(1) or 460(b)(1)(A) of the Higher Education Act of 
1965 (20 U.S.C. 1078-10 and 1087j) as such sections were in effect on 
the day before the date of enactment of this Act, shall--
            (1) be eligible to receive loan forgiveness or loan 
        cancellation in the amount described in, and in accordance with 
        the requirements of, such sections as in effect on the day 
        before the date of enactment of this Act; and
            (2) not be eligible to receive loan forgiveness under 
        section 428J of the Higher Education Act of 1965 as in effect 
        on the date of enactment of this Act.
Teacher and Nurse Support Act of 2007 - Amends the Higher Education Act of 1965 to increase to a maximum of $17,500 the aggregate student loan obligation eligible for forgiveness or cancellation under the Federal Family Education Loan or Direct Loan programs for teachers who serve full-time in certain elementary or secondary schools that enroll a high proportion of disadvantaged students.

Includes, under these student loan forgiveness and cancellation programs, nurses who serve in a clinical setting or as a member of the nursing faculty at an accredited school of nursing. Directs the Secretary of Education to repay such loan obligation in annual installments up to specified maximum amounts after each of five years of such service.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Financial Information Privacy Act of 
1999''.

SEC. 2. DEFINITIONS.

    In this Act--
            (1) the term ``covered person'' means a person that is 
        subject to the jurisdiction of any of the Federal financial 
        regulatory authorities; and
            (2) the term ``Federal financial regulatory authorities'' 
        means--
                    (A) each of the Federal banking agencies, as that 
                term is defined in section 3(z) of the Federal Deposit 
                Insurance Act; and
                    (B) the Securities and Exchange Commission.

SEC. 3. PRIVACY OF CONFIDENTIAL CUSTOMER INFORMATION.

    (a) Rulemaking.--The Federal financial regulatory authorities shall 
jointly issue final rules to protect the privacy of confidential 
customer information relating to the customers of covered persons, not 
later than 270 days after the date of enactment of this Act (and shall 
issue a notice of proposed rulemaking not later than 150 days after the 
date of enactment of this Act), which rules shall--
            (1) define the term ``confidential customer information'' 
        to be personally identifiable data that includes transactions, 
        balances, maturity dates, payouts, and payout dates, of--
                    (A) deposit and trust accounts;
                    (B) certificates of deposit;
                    (C) securities holdings; and
                    (D) insurance policies;
            (2) require that a covered person may not disclose or share 
        any confidential customer information to or with any affiliate 
        or agent of that covered person if the customer to whom the 
        information relates has provided written notice, as described 
        in paragraphs (4) and (5), to the covered person prohibiting 
        such disclosure or sharing--
                    (A) with respect to an individual that became a 
                customer on or after the effective date of such rules, 
                at the time at which the business relationship between 
                the customer and the covered person is initiated and at 
                least annually thereafter; and
                    (B) with respect to an individual that was a 
                customer before the effective date of such rules, at 
                such time thereafter that provides a reasonable and 
                informed opportunity to the customer to prohibit such 
                disclosure or sharing and at least annually thereafter;
            (3) require that a covered person may not disclose or share 
        any confidential customer information to or with any person 
        that is not an affiliate or agent of that covered person unless 
        the covered person has first--
                    (A) given written notice to the customer to whom 
                the information relates, as described in paragraphs (4) 
                and (5); and
                    (B) obtained the informed written or electronic 
                consent of that customer for such disclosures or 
                sharing;
            (4) require that the covered person provide notices and 
        consent acknowledgments to customers, as required by this 
        section, in separate and easily identifiable and 
        distinguishable form;
            (5) require that the covered person provide notice as 
        required by this section to the customer to whom the 
        information relates that describes what specific types of 
        information would be disclosed or shared, and under what 
        general circumstances, to what specific types of businesses or 
        persons, and for what specific types of purposes such 
        information could be disclosed or shared;
            (6) require that the customer to whom the information 
        relates be provided with access to the confidential customer 
        information that could be disclosed or shared so that the 
        information may be reviewed for accuracy and corrected or 
        supplemented;
            (7) require that, before a covered person may use any 
        confidential customer information provided by a third party 
        that engages, directly or indirectly, in activities that are 
        financial in nature, as determined by the Federal financial 
        regulatory authorities, the covered person shall take 
        reasonable steps to assure that procedures that are 
        substantially similar to those described in paragraphs (2) 
        through (6) have been followed by the provider of the 
        information (or an affiliate or agent of that provider); and
            (8) establish a means of examination for compliance and 
        enforcement of such rules and resolving consumer complaints.
    (b) Limitation.--The rules prescribed pursuant to subsection (a) 
may not prohibit the release of confidential customer information--
            (1) that is essential to processing a specific financial 
        transaction that the customer to whom the information relates 
        has authorized;
            (2) to a governmental, regulatory, or self-regulatory 
        authority having jurisdiction over the covered financial entity 
        for examination, compliance, or other authorized purposes;
            (3) to a court of competent jurisdiction;
            (4) to a consumer reporting agency, as defined in section 
        603 of the Fair Credit Reporting Act for inclusion in a 
        consumer report that may be released to a third party only for 
        a purpose permissible under section 604 of that Act; or
            (5) that is not personally identifiable.
    (c) Construction.--Nothing in this section or the rules prescribed 
under this section shall be construed to amend or alter any provision 
of the Fair Credit Reporting Act.
Financial Information Privacy Act of 1999 - Directs the Federal financial regulatory authorities (banking regulatory agencies and the Securities and Exchange Commission (SEC)) to jointly issue final rules to protect the privacy of confidential information relating to customers of institutions under their respective jurisdictions (covered institution). 
Mandates that such rules: (1) prohibit a covered institution from disclosing or sharing confidential customer information with any affiliate or agent if the customer has provided a written notice which forbids such disclosure; (2) prohibit a covered institution from disclosing or sharing confidential customer information with a non-affiliate or non-agent unless the customer has provided written or electronic consent; (3) require the covered institution to disclose to the customer the specific type of information disclosed or shared, under what circumstances, to what specific types of businesses, and for what types of purposes; (4) require customer access to information that could be disclosed so that it may be reviewed for accuracy and supplementation; and (5) establish a compliance and enforcement mechanism that includes consumer complaint resolution. 
Cites circumstances under which such information may be released.

SECTION 1. HUMAN TISSUE.

    (a) In General.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(hh)(1) The term `human tissue' means a collection of similar 
human cells which--
            ``(A) is intended for use in the diagnosis, cure, 
        mitigation, treatment, or prevention of a disease or condition 
        in a human or for reproduction;
            ``(B) achieves its primary intended purpose through repair 
        or replacement of bodily tissue by structural support or 
        cellular function;
            ``(C) may have been propagated or otherwise processed 
        before use;
            ``(D) may be combined with substances that are safe under 
        conditions of intended use and not intended to provide a 
        therapeutic effect; and
            ``(E) includes reproductive tissue, demineralized bone, 
        heart valves, dura mater, and manipulated autologous cells.
    ``(2) The term `human tissue' does not include vascularized human 
organs, gene therapy, blood, soluble blood components, milk, or 
products made by combining human tissue with biomaterials.
    ``(3) Human tissue is not a drug, biological product, or device 
unless reclassified by the Secretary pursuant to section 352A of the 
Public Health Service Act.''.
    (b) Regulation of Human Tissue.--Subpart 1 of part F of title III 
of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by 
adding at the end the following section:

                      ``regulation of human tissue

    ``Sec. 352A. (a) Subject to Regulation.--
            ``(1) In general.--Human tissue shall be subject to 
        regulation under this section only if the Secretary publishes a 
        finding in the Federal Register, after a hearing before the 
        Commissioner, that voluntary regulation under generally 
        accepted scientific standards is inadequate to protect the 
        public health with respect to any particular type of human 
        tissue or human tissue generally.
            ``(2) Exception.--Human tissue shall not be subject to 
        regulation as a drug, biological product, or device unless it 
        is reclassified under subsection (f).
    ``(b) Registration.--
            ``(1) In general.--Any person subject to regulation under 
        this section who recovers, processes, stores, or distributes 
        human tissue for transplantation or implantation in the United 
        States shall register in accordance with the registration 
        procedures established for drugs under section 510 of the 
        Federal Food, Drug, and Cosmetic Act. Such registration shall 
        contain the name of the person, the location of its facilities, 
        a list of the types of human tissue recovered, processed, 
        stored, or distributed by such person, and a brief description 
        of the basic method or methods of processing of such tissue.
            ``(2) Authorized activities.--A person registered in 
        accordance with paragraph (1) shall be deemed to be authorized 
        to conduct human tissue recovery, processing, storage, and 
        distribution activities as identified in the applicable 
        registration unless--
                    ``(A)(i) the Secretary determines, upon inspection, 
                that such person fails to meet applicable operating 
                standards under subsection (c);
                    ``(ii) the Secretary notifies such person of a 
                determination under clause (i), advises the person of 
                the steps necessary to meet such standards, and 
                provides the person with a reasonable opportunity to 
                establish compliance with the standards;
                    ``(iii) the Secretary determines, after an 
                opportunity for an informal hearing, that the person 
                has failed to establish compliance as provided for in 
                clause (ii) within the applicable period and such 
                failure constitutes a threat to the public health; and
                    ``(iv) the Secretary suspends or revokes the 
                authority to conduct such activities;
                    ``(B) the Secretary determines, after an 
                opportunity for an informal hearing, that such person 
                has failed to comply with any patient registry or other 
                retrospective patient data requirement, and the 
                Secretary suspends or revokes the authority to conduct 
                such activities; or
                    ``(C) the Secretary determines that such person 
                presents an immediate or substantial danger to the 
                public health, and the Secretary suspends or revokes 
                the authority to conduct such activities, in which case 
                an informal hearing shall be conducted within 5 
                business days of the date of such suspension or 
                revocation.
    ``(c) Operating Standards.--The Secretary may establish, after 
notice and opportunity for comment, operating standards for human 
tissue that shall be limited to the following general requirements for 
the recovery, processing, storage, and shipment of human tissue:
            ``(1) Requirements for infection control designed to 
        prevent transmission of disease.
            ``(2) Requirements for processing practices that assure the 
        safety of, and prevent damage to, human tissue.
            ``(3) Requirements for labeling and recordkeeping to 
        identify the type of tissue and any added foreign substance and 
        to permit tracing.
    ``(d) Labeling and Advertising.--Statements made in labeling, 
advertising or promotional materials regarding clinical benefit with 
respect to human tissue shall consist only of accurate and balanced 
representations that are consistent with sound scientific information, 
including current data from a registry required or established under 
subsection (e), if available.
    ``(e) Registry.--A person registered under subsection (b) may be 
required by the Secretary to maintain a patient registry or meet other 
retrospective patient data requirements if, after notice and an 
opportunity for comment, the Secretary determines that such tissue has 
been commercially available within the United States for a period of 
less than 5 years and that such data requirement is necessary to 
protect the public health.
    ``(f) Reclassifications.--
            ``(1) Human tissue.--The Secretary may reclassify a 
        particular type of human tissue as a drug, biological product 
        or device if, after notice and an opportunity for comment, the 
        Secretary determines that--
                    ``(A) with respect to the particular type of human 
                tissue--
                            ``(i) the tissue is subject to a patient 
                        registry or other retrospective data 
                        requirement under which the collection of 
                        information has been required for at least 5 
                        years (or such other time period as agreed to 
                        by the Secretary and the registered person); 
                        and
                            ``(ii) the information received from such 
                        patient registry or other retrospective data 
                        requirement is insufficient to confirm the 
                        safety and clinical benefit from the use of 
                        such tissue; or
                    ``(B) a particular type of human tissue should be 
                reclassified because it presents an imminent hazard to 
                public health.
            ``(2) Upon secretarial action.--The Secretary may 
        reclassify a human drug, biological product or medical device 
        as human tissue if the Secretary determines, after notice and 
        an opportunity for comment, that such previous classification 
        is not necessary to protect public health.
            ``(3) Upon petition.--The Secretary may reclassify a drug, 
        biological product, medical device, or human tissue upon the 
        petition of the sponsor of such drug, biological product or 
        device, or the registered person for such human tissue, if, 
        after notice and an opportunity to comment, the Secretary finds 
        that such reclassification is consistent with the protection of 
        public health.
    ``(g) Enforcement.--
            ``(1) In general.--If the Secretary determines that any 
        person has violated any provision of this section or any 
        regulations promulgated under this section, and the Secretary 
        determines that the violation constitutes a significant risk to 
        the public health, the Secretary may issue an order that such 
        person cease distribution of human tissue, or that human tissue 
        recovered, processed, stored or distributed by such person be 
        retained, recalled, or destroyed. After receipt of such an 
        order, the person in possession of the human tissue shall not 
        distribute or dispose of the human tissue in any manner 
        inconsistent with the provisions of the order.
            ``(2) Hearing.--A person subject to the order under 
        paragraph (1) may obtain an informal hearing regarding the 
        order if the person requests such a hearing not later than 5 
        days after receiving the order. If the person does make such a 
        request within such period, the Secretary shall conduct the 
hearing within 30 days after receiving the request and shall issue an 
order not later than 15 days after the hearing is conducted. Such order 
shall be considered a final order of the Secretary.
    ``(h) Inspection.--Each person registered under subsection (b) 
shall be subject to inspection under section 704 of the Federal Food, 
Drug, and Cosmetic Act. The Secretary may, with the concurrence of the 
registered person, authorize an inspection to be conducted by any 
person specifically accredited by the Secretary to conduct such 
inspection under section 712 of such Act.
    ``(i) Cord Blood.--
            ``(1) In general.--This section (including provisions 
        regarding reclassification) shall apply with respect to cord 
        blood to the same extent and in the same manner as this section 
        applies with respect to human tissue.
            ``(2) Implementation.--The Secretary shall implement this 
        section with respect to cord blood under regulations 
        promulgated after notice and opportunity to comment.
    ``(j) Eyes.--The Secretary shall not regulate eyes until such time 
as the Secretary makes a finding under this section that voluntary 
regulation under generally accepted standards is inadequate to protect 
the public health.''.
    (c) Transition.--The requirements of the interim regulation, 
promulgated by the Secretary of Health and Human Services on December 
11, 1993, shall remain in effect until amended or withdrawn by the 
Secretary. Any modifications to such regulations after the date of the 
enactment of this Act are subject to this Act and the amendments made 
by this Act.
    (d) Effective Date.--The amendment made by subsection (c) shall 
take effect on June 30, 1997.
    (e) Conforming Amendments.--
            (1) Adulteration provision.--Section 501 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended--
                    (A) in the first sentence by striking ``drug or 
                device'' and inserting ``drug, device or human 
                tissue''; and
                    (B) by adding at the end thereof the following:
    ``(j) if it is human tissue and it is recovered, processed, stored, 
or distributed by--
            ``(1) a registered person under section 352A of the Public 
        Health Service Act whose failure to comply with standards 
        constitutes a threat to public health; or
            ``(2) a person who is required under such section to 
        register but has failed to do so.''.
            (2) Misbranding provisions.--Section 502 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended:
                    (A) in the section heading, but striking 
                ``MISBRANDED DRUGS AND DEVICES'' and inserting the 
                following: ``MISBRANDED DRUGS, DEVICES, AND HUMAN 
                TISSUE''; and
                    (B) in the first sentence, by striking ``drug or 
                device'' and inserting ``drug, device or human 
                tissue''.
            (3) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end thereof the following:
    ``(v) The adulteration or misbranding of any human tissue.''.
            (4) Seizure.--Section 304 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 334) is amended--
                    (A) in subsection (a)(2)(D), by inserting ``or 
                human tissue'' after ``device''; and
                    (B) in the first sentence of subsection (d)(1), by 
                striking ``or cosmetic'' and inserting ``cosmetic, or 
                human tissue''.
            (5) Inspection.--Section 704(a)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended--
                    (A) in the first sentence, by inserting ``human 
                tissue,'' after ``device,'' each place such appears; 
                and
                    (B) in the second sentence, by inserting ``human 
                tissue,'' after ``drugs,'' each place such appears.

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a specific definition for "human tissue" which expressly excludes vascularized human organs, gene therapy, blood, soluble blood components, milk, or products made by combining human tissue with biomaterials.  Declares that human tissue is not a drug, biological product, or device unless reclassified under this Act. 
Amends the Public Health Service Act (PHSA) to subject human tissue to regulation under such Act only if voluntary regulation is inadequate, or if it is reclassified as a drug, biological product, or device pursuant to specified guidelines established by this Act. 
Requires any person subject to such regulation who recovers, processes, stores, or distributes human tissue for transplantation or implantation in the United States to register in accordance with FFDCA drug registration procedures.  Deems registrants to be authorized to conduct human tissue recovery, processing, storage, and distribution activities identified as applicable on the registration, unless, among other things, the Secretary of Health and Human Services suspends or revokes such authority after determining that the registrant fails to meet operating standards established by the Secretary. 
Prescribes certain human tissue labeling and advertising requirements. 
Authorizes the Secretary to reclassify human tissue as a drug, biological product, or device in specified circumstances. 
Outlines the mechanism for enforcement of this Act in the event that any violations of it constitute a significant risk to the public health. 
Subjects registrants to inspections under the Act. 
Applies the PHSA to umbilical cord blood to the same extent as it applies to human tissue. 
Prohibits the Secretary from regulating eyes until voluntary regulation is inadequate to protect the public health.