[Federal Register Volume 63, Number 216 (Monday, November 9, 1998)]
[Notices]
[Pages 60351-60352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29903]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Ryan White Care Act Requirement--Secretary's Determination on HIV 
Testing of Newborns

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice and request for comments.

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SUMMARY: Section 2626 of P.L. 104-146 (42 U.S.C. 300ff-34), the ``Ryan 
White CARE Act Amendments of 1996'', includes a requirement for the 
Secretary of HHS to make a determination whether a set of activities 
prescribed in section 2627 of the Public Health Service (PHS) Act (42 
U.S.C. 300ff-35), have become routine practice in the United States. In 
making this determination, the Secretary is required to consult with 
the States and other public or private entities that have knowledge or 
expertise relevant to the determination.
    The purpose of this notice is to request comments from States and 
such other public or private entities with knowledge or expertise 
relevant to the practice of activities (1) through (4) in section 2627 
of the PHS Act (42 U.S.C. 300ff-35). After consideration of comments 
submitted, the CDC will provide a summary of comments received to the 
Secretary as part of the process leading to the Secretary's 
determination required by Section 2626 of the PHS Act (42 U.S.C. 300ff-
34).

DATES: The public is invited to submit comments on the practice of 
activities (1) through (4) in Section 2627 of the PHS Act by November 
23, 1998.

ADDRESSES: Comments should be submitted to: Technical Information and 
Communication Branch, Division of HIV/AIDS Prevention--Intervention, 
Research, and Support, National Center for HIV, STD and TB Prevention, 
Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, 
NE., Mailstop E-49, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT: Technical Information and 
Communication Branch, Division of HIV/AIDS Prevention--Intervention, 
Research, and Support, National Center for HIV, STD and TB Prevention, 
Centers for Disease Control and Prevention (CDC), telephone (404) 639-
2072.

SUPPLEMENTARY INFORMATION: Section 2626(d) of the Public Health Service 
Act (42 U.S.C. 300ff-34), directs the Secretary to publish in the 
Federal Register ``a determination of whether it has become a routine 
practice in the provision of health care in the United States to carry 
out each of the activities described in paragraphs (1) through (5) of 
section 2627. In making the determination, the Secretary shall consult 
with the States and with other public or private entities that have 
knowledge or experience relevant to the determination.'' The activities 
described in section 2627 are as follows: ``(1) 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. (2) 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 adoptive 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. (3) That, in the case 
of prenatal testing for HIV disease that is conducted in the State, the 
results of such testing be promptly disclosed to the pregnant woman 
involved. (4) That, in disclosing the test results to an individual 
under paragraph (2) or (3), appropriate counseling on the human 
immunodeficiency virus be made available to the individual (except in 
the case of a disclosure to an official of a State or an authorized 
agency).'' The requirement of Section 2627 (5) was deleted for the 
purposes of Section 2626 through a subsequent technical amendment 
enacted into law.
    The term routine practice provided in section 2626 (d) was not 
defined within the statute of Public Law 104-146 (42 U.S.C. 300ff-34) . 
The joint explanatory statement of the committee on conference included 
the following legislative history on page 46 of the Conference Report 
104-545 regarding the Secretary's determination: ``(2) Within 2 years 
following the implementation of such a system, the Secretary will make 
a determination whether mandatory HIV testing of all infants born in 
the U.S. whose mothers have not undergone prenatal HIV testing has 
become a routine practice. This determination will be made in 
consultation with States and experts.''
    Section 2628 of the Public Health Service Act (42 U.S.C. 300ff-36) 
directs the Secretary to request that the Institute of Medicine (IOM) 
of the National Academy of Sciences evaluate the extent to which State 
efforts have been effective in reducing the perinatal transmission of 
HIV and an analysis of the existing barriers to the further reduction 
in such transmission. The IOM assembled a 14-member expert committee 
with combined expertise in obstetrics and gynecology, pediatrics, 
preventive medicine, and other relevant specialties, social and 
behavioral sciences, public health practice, epidemiology, program 
evaluation, health services research, bioethics, and public health law. 
The IOM committee

[[Page 60352]]

reviewed a wide variety of quantitative and qualitative information 
pertaining to the prevention of perinatal HIV transmission. To augment 
the committee's two public workshops and a series of site visits 
through which the committee consulted a wide array of state and local 
public health officials and other policy makers, health care providers, 
consumers, ethicists, advocacy groups for women and children with HIV 
and others affected and concerned with these policy issues.
    This notice will build upon the testimony and material already 
provided to the IOM as part of its statutorily required evaluation by 
seeking any additional public comment beyond that already provided to 
the IOM as part of its consultative process. The purpose of this notice 
is not to duplicate the testimony, data or other information and 
background material already provided to the IOM committee through its 
workshops, site visits, and other information gathering and 
consultative activities.

    Dated: November 3, 1998.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 98-29903 Filed 11-6-98; 8:45 am]
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