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

Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Captive Primate Safety Act''.

SEC. 2. ADDITION OF NONHUMAN PRIMATES TO DEFINITION OF PROHIBITED 
              WILDLIFE SPECIES.

    Section 2(g) of the Lacey Act Amendments of 1981 (16 U.S.C. 
3371(g)) is amended by inserting before the period at the end ``or any 
nonhuman primate''.

SEC. 3. CAPTIVE WILDLIFE AMENDMENTS.

    (a) Prohibited Acts.--Section 3 of the Lacey Act Amendments of 1981 
(16 U.S.C. 3372) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2)--
                            (i) in subparagraph (A), by inserting 
                        ``or'' after the semicolon;
                            (ii) in subparagraph (B)(iii), by striking 
                        ``; or'' and inserting a semicolon; and
                            (iii) by striking subparagraph (C); and
                    (B) in paragraph (4), by inserting ``or subsection 
                (e)'' before the period; and
            (2) in subsection (e)--
                    (A) by redesignating paragraphs (2), (3), (4), and 
                (5) as paragraphs (3), (4), (5), and (6) respectively;
                    (B) by striking ``(e)'' and all that follows 
                through ``Subsection (a)(2)(C) does not apply'' in 
                paragraph (1) and inserting the following:
    ``(e) Captive Wildlife Offense.--
            ``(1) In general.--It is unlawful for any person to import, 
        export, transport, sell, receive, acquire, or purchase in 
        interstate or foreign commerce any live animal of any 
        prohibited wildlife species.
            ``(2) Limitation on application.--This subsection--
                    ``(A) does not apply to a person transporting a 
                nonhuman primate to or from a veterinarian who is 
                licensed to practice veterinary medicine within the 
                United States, solely for the purpose of providing 
                veterinary care to the nonhuman primate, if--
                            ``(i) the person transporting the nonhuman 
                        primate carries written documentation issued by 
                        the veterinarian, including the appointment 
                        date and location;
                            ``(ii) the nonhuman primate is transported 
                        in a secure enclosure appropriate for that 
                        species of primate;
                            ``(iii) the nonhuman primate has no contact 
                        with any other animals or members of the 
                        public, other than the veterinarian and other 
                        authorized medical personnel providing 
                        veterinary care; and
                            ``(iv) such transportation and provision of 
                        veterinary care is in accordance with all 
                        otherwise applicable State and local laws, 
                        regulations, permits, and health certificates;
                    ``(B) does not apply to a person transporting a 
                nonhuman primate to a legally designated caregiver for 
                the nonhuman primate as a result of the death of the 
                preceding owner of the nonhuman primate, if--
                            ``(i) the person transporting the nonhuman 
                        primate is carrying legal documentation to 
                        support the need for transporting the nonhuman 
                        primate to the legally designated caregiver;
                            ``(ii) the nonhuman primate is transported 
                        in a secure enclosure appropriate for the 
                        species;
                            ``(iii) the nonhuman primate has no contact 
                        with any other animals or members of the public 
                        while being transported to the legally 
                        designated caregiver; and
                            ``(iv) all applicable State and local 
                        restrictions on such transport, and all 
                        applicable State and local requirements for 
                        permits or health certificates, are complied 
                        with;
                    ``(C) does not apply to a person transporting a 
                nonhuman primate solely for the purpose of assisting an 
                individual who is permanently disabled with a severe 
                mobility impairment, if--
                            ``(i) the nonhuman primate is a single 
                        animal of the genus Cebus;
                            ``(ii) the nonhuman primate was obtained 
                        from, and trained at, a licensed nonprofit 
                        organization described in section 501(c)(3) of 
                        the Internal Revenue Code of 1986 the nonprofit 
                        tax status of which was obtained--
                                    ``(I) before July 18, 2008; and
                                    ``(II) on the basis that the 
                                mission of the organization is to 
                                improve the quality of life of severely 
                                mobility-impaired individuals;
                            ``(iii) the person transporting the 
                        nonhuman primate is a specially trained 
                        employee or agent of a nonprofit organization 
                        described in clause (ii) that is transporting 
                        the nonhuman primate to or from a designated 
                        individual who is permanently disabled with a 
                        severe mobility impairment, or to or from a 
                        licensed foster care home providing specialty 
                        training of the nonhuman primate solely for 
                        purposes of assisting an individual who is 
                        permanently disabled with severe mobility 
                        impairment;
                            ``(iv) the person transporting the nonhuman 
                        primate carries documentation from the 
                        applicable nonprofit organization that includes 
                        the name of the designated individual referred 
                        to in clause (iii);
                            ``(v) the nonhuman primate is transported 
                        in a secure enclosure that is appropriate for 
                        that species;
                            ``(vi) the nonhuman primate has no contact 
                        with any animal or member of the public, other 
                        than the designated individual referred to in 
                        clause (iii); and
                            ``(vii) the transportation of the nonhuman 
                        primate is in compliance with--
                                    ``(I) all applicable State and 
                                local restrictions regarding the 
                                transport; and
                                    ``(II) all applicable State and 
                                local requirements regarding permits or 
                                health certificates; and
                    ``(D) does not apply'';
                    (C) in paragraph (2) (as added by subparagraph 
                (B))--
                            (i) by striking ``a'' before ``prohibited'' 
                        and inserting ``any'';
                            (ii) by striking ``(3)'' and inserting 
                        ``(4)''; and
                            (iii) by striking ``(2)'' and inserting 
                        ``(3)'';
                    (D) in paragraph (3) (as redesignated by 
                subparagraph (A))--
                            (i) in subparagraph (C)--
                                    (I) in clauses (ii) and (iii), by 
                                striking ``animals listed in section 
                                2(g)'' each place it appears and 
                                inserting ``prohibited wildlife 
                                species''; and
                                    (II) in clause (iv), by striking 
                                ``animals'' and inserting ``prohibited 
                                wildlife species''; and
                            (ii) in subparagraph (D), by striking 
                        ``animal'' each place it appears and inserting 
                        ``prohibited wildlife species'';
                    (E) in paragraph (4) (as redesignated by 
                subparagraph (A)), by striking ``(2)'' and inserting 
                ``(3)''; and
                    (F) in paragraph (6) (as redesignated by 
                subparagraph (A))--
                            (i) by striking ``subsection (a)(2)(C)'' 
                        and inserting ``this subsection''; and
                            (ii) by striking ``2004 through 2008'' and 
                        inserting ``2011 through 2015''.
    (b) Civil Penalties.--Section 4(a) of the Lacey Act Amendments of 
1981 (16 U.S.C. 3373(a)) is amended--
            (1) in paragraph (1), by inserting ``(e),'' after 
        ``subsections (b), (d),''; and
            (2) in paragraph (1), by inserting ``, (e),'' after 
        ``subsection (d)''.
    (c) Criminal Penalties.--Section 4(d) of the Lacey Act Amendments 
of 1981 (16 U.S.C. 3373(d)) is amended--
            (1) in paragraphs (1)(A) and (1)(B) and in the first 
        sentence of paragraph (2), by inserting ``(e),'' after 
        ``subsections (b), (d),'' each place it appears; and
            (2) in paragraph (3), by inserting ``, (e),'' after 
        ``subsection (d)''.
    (d) Effective Date; Regulations.--
            (1) Effective date.--Subsections (a) through (c), and the 
        amendments made by those subsections, shall take effect on the 
        earlier of--
                    (A) the date of promulgation of regulations under 
                paragraph (2); and
                    (B) the expiration of the period referred to in 
                paragraph (2).
            (2) Regulations.--Not later than 180 days after the date of 
        enactment of this Act, the Secretary of the Interior shall 
        promulgate regulations implementing the amendments made by this 
        section.

SEC. 4. APPLICABILITY PROVISION AMENDMENT.

    Section 3 of the Captive Wildlife Safety Act (117 Stat. 2871; 
Public Law 108-191) is amended--
            (1) in subsection (a), by striking ``(a) In General.--
        Section 3'' and inserting ``Section 3''; and
            (2) by striking subsection (b).

SEC. 5. REGULATIONS.

    Section 7(a) of the Lacey Act Amendments of 1981 (16 U.S.C. 
3376(a)) is amended by adding at the end the following:
            ``(3) The Secretary shall, in consultation with other 
        relevant Federal and State agencies, promulgate regulations to 
        implement section 3(e).''.

Output: Captive Primate Safety Act - Amends the Lacey Act Amendments of 1981 to add nonhuman primates to the definition of "prohibited wildlife species" for purposes of the prohibition against the sale or purchase of such species in interstate or foreign commerce.

Makes it unlawful for a person to import, export, transport, sell, receive, acquire, or purchase a live animal of any prohibited wildlife species in interstate or foreign commerce (i.e., for pet trade purposes). Sets forth exceptions to such prohibition, including, under certain conditions, for: (1) transporting a nonhuman primate to or from a veterinarian, (2) transporting a nonhuman primate to a legally designated caregiver as a result of the death of the preceding owner, and (3) transporting a single primate of the genus Cebus that was obtained from and trained by a charitable organization to assist a permanently disabled individual with a severe mobility impairment.

Sets forth civil and criminal penalties for violations of the requirements of this Act. Extends the authorization of appropriations to carry out such prohibition for FY2011-FY2015.


Input: Consider 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.

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.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Women and Children's HIV Protection 
Act of 2003''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Perinatal transmission is the leading cause of 
        pediatric HIV infections, including AIDS cases.
            (2) The Centers for Disease Control and Prevention 
        (``CDC'') estimates that nearly 7,000 HIV-infected women give 
        birth in the United States each year and as many as 400 babies 
        continue to be born with HIV infection each year.
            (3) Medical advances have made it possible to nearly 
        eliminate perinatal HIV transmission.
            (4) Research studies have demonstrated that the 
        administration of antiviral medication during pregnancy, during 
        labor, and immediately following birth can significantly reduce 
        the transmission of HIV from an infected mother to her baby. 
        Caesarean section further reduces the risk of transmission.
            (5) Even if treatment begins shortly after birth, 
        antiretroviral therapy can substantially reduce the chance that 
        an HIV-exposed infant will become infected.
            (6) Breastfeeding by HIV-infected mothers poses additional 
        significant risk of infection to babies.
            (7) The Institute of Medicine (``IOM'') has recommended the 
        adoption of a national policy of universal HIV testing, with 
        patient notification, as a routine component of prenatal care. 
        However, 15 percent of HIV-infected pregnant women receive no 
        prenatal care according to the IOM.
            (8) The CDC has recommended since 1995 that all pregnant 
        women be counseled and offered voluntary HIV testing. Yet 
        nearly half of pregnant women are still not tested according to 
        the CDC. The CDC has found that mandatory testing of newborns 
        and universal HIV testing of pregnant woman are the best 
        approaches for identifying, treating, and preventing HIV among 
        pregnant women and children.
            (9) The American Medical Association recommends mandatory 
        HIV testing of all newborns with appropriate treatment for 
        affected mothers and children.
            (10) Testing newborns whose mothers' status is unknown 
        ensures that every child at risk for HIV is identified.
            (11) More than a third of the HIV infections that occur 
        annually among newborns in the United States could be prevented 
        with routine HIV testing of pregnant woman or newborns 
        according to a 2002 report by the Inspector General of the 
        Department of Health and Human Services. This represents over 
        100 babies born every year that are needlessly infected.
            (12) The provision of testing of pregnant women and 
        newborns with appropriate counseling and treatment can 
        significantly reduce the number of pediatric HIV infections, 
        including AIDS cases, can improve access to and medical care 
        for the woman and children, and can provide opportunities to 
        further reduce transmission among adults.
            (13) The provision of such testing, counseling, and 
        treatment can reduce the overall cost of pediatric HIV 
        infections, including AIDS cases.
            (14) New York State has required mandatory HIV counseling 
        and voluntary testing for pregnant women and mandatory HIV 
        testing of all newborns since February 1997. As a result, the 
        perinatal HIV transmission rate in the State has dropped from 
        25 percent to an all time low of 3.5 percent and over 99 
percent of HIV-infected women and their children have been linked to 
care.
    (15) For the foregoing reasons--
                    (A) universal routine HIV testing of pregnant women 
                and newborns should be the standard of care; and
                    (B) the relevant medical organizations, as well as 
                public health officials, should issue guidelines making 
                such testing, counseling, and treatment the standard of 
                care.

SEC. 3. GRANTS REGARDING COUNSELING AND TESTING OF PREGNANT WOMEN AND 
              NEWBORN INFANTS.

    Subpart II of part B of title XXVI of the Public Health Service Act 
(42 U.S.C. 300ff-33 et seq.) is amended by inserting after section 2625 
the following section:

``SEC. 2625A. GRANTS REGARDING COUNSELING AND TESTING OF PREGNANT WOMEN 
              AND NEWBORN INFANTS.

    ``(a) In General.--Of the amounts appropriated under section 2677 
for a fiscal year for carrying out this part, exclusive of amounts 
available for grants under section 2618(a)(2)(I), the Secretary, 
subject to subsection (b)(2), shall reserve $82,875,000 for making 
grants to each State that demonstrates that the law or regulations of 
the State are in accordance with the following:
            ``(1) That all pregnant women receiving prenatal care in 
        the State be offered counseling and testing regarding HIV 
        disease.
            ``(2) In the case of prenatal testing for such disease that 
        is conducted in the State, that the results of such testing be 
        promptly disclosed to the pregnant woman involved.
            ``(3) In the case of newborn infants who are born in the 
        State and whose biological mothers have not undergone prenatal 
        testing for HIV disease, that each such infant undergo testing 
        for such disease.
            ``(4) That the results of such testing of a newborn infant 
        be promptly disclosed in accordance with the following, as 
        applicable to the infant involved:
                    ``(A) To the biological mother of the infant 
                (without regard to whether she is the legal guardian of 
                the infant).
                    ``(B) If the State is the legal guardian of the 
                infant:
                            ``(i) To the appropriate official of the 
                        State agency with responsibility for the care 
                        of the infant.
                            ``(ii) To the appropriate official of each 
                        authorized agency providing assistance in the 
                        placement of the infant.
                            ``(iii) If the authorized agency is giving 
                        significant consideration to approving an 
                        individual as a foster parent of the infant, to 
                        the prospective foster parent.
                            ``(iv) If the authorized agency is giving 
                        significant consideration to approving an 
                        individual as an adoptive parent of the infant, 
                        to the prospective adoptive parent.
                    ``(C) If neither the biological mother nor the 
                State is the legal guardian of the infant, to another 
                legal guardian of the infant.
                    ``(D) To the child's health care provider.
            ``(5) That, in disclosing the test results to an individual 
        under paragraph (2) or (4), appropriate counseling on HIV 
        disease and appropriate referrals for health care be offered to 
        the individual (except in the case of a disclosure to an 
        official of a State or an authorized agency, or to a health 
        care provider).''.
    ``(b) Date Certain for Making Grants; Limitation on Reservation of 
Funds.--
            ``(1) Date certain for making grants.--Not later than the 
        end of the three-month period beginning on the date on which 
        appropriations first become available for a fiscal year for 
        grants under section 2611, the Secretary shall make grants 
        under subsection (a) for such fiscal year to all States that 
        seek such grants and meet the condition described in such 
        subsection for the grants.
            ``(2) Limitation on reservation of funds.--Effective upon 
        the expiration of the period described in paragraph (1) with 
        respect to a fiscal year, the unobligated portion of the amount 
        reserved under subsection (a) for the fiscal year is available 
        for grants under section 2611 for the fiscal year.
    ``(c) Amount of Grants.--Each grant under subsection (a) for a 
fiscal year shall be made in the amount of $1,500,000, except that the 
amount of such a grant for a territory of the United States shall be 
$375,000.
    ``(d) Authorized Expenditures.--A grant under subsection (a) may be 
expended for any purpose for which a grant under 2611 is authorized to 
be expended.
    ``(e) Definitions.--For purposes of this section, the terms `State' 
and `territory of the United States' have the meanings that apply to 
such terms for purposes of grants under section 2611 (including the 
meanings that apply for purposes of section 2618).''.


Output: Women and Children's HIV Protection Act of 2003 - Amends the Public Health Service Act to provide for grants regarding the counseling and testing of pregnant women and newborn infants out of moneys appropriated under the care grant program. Prohibits making a grant to a State unless the State demonstrates that the law or regulations of the State require specified testing and services for pregnant women and newborn infants regarding HIV disease.