All,

I received the following e-mail.  FOr the PD community the 3rd is most
important and has been addressed here on the list before.  I am presenting
these for all for discussion here  and comment to NIH.

Charlie

----- Original Message -----
From: NIH Office of Communications and Public Liaison
Sent: Wednesday, December 22, 1999 11:01 AM
Subject: Option for Public Comments on Three Policy Issues-FYI only

...This is for your information only.  The issues referenced below all
happen to have public comment periods.  We want to make you aware of these
kinds of options for public comment if you are interested, but please don't
feel pressured or obligated in any way to respond.

There has been quite a bit of recent activity concerning some broad policy
issues that concern NIH.  All three of these issues happen to have a public
comment period.  Two of the issues request comments be made by
January 31, 2000, and the third issue, the proposed health privacy rule,
request comments be provided to the Department of Health and Human
Services no later than February 17, 2000.

For your information, we have provided brief summaries on each issue
with the link to the public comments section on each Web site.

FYI - Three issues for public comment:

Issue 1:  Call for public comments on oversight of genetic testing.

The Secretary's Advisory Committee on Genetic Testing (SACGT) is
seeking public comments on the adequacy of current oversight of genetic
testing in the United States.  The Human Genome Project and other
advancements in genetics and genetic testing are expected to revolutionize
clinical and public health practice, changes that may also have a
significant
impact on society.  SACGT was chartered to advise the U.S. Department of
Health and Human Services on the medical, scientific, ethical, legal, and
social issues raised by the development and use of genetic tests.  Its first
assignment is to assess the adequacy of oversight of genetic testing in
consultation with the public and, if necessary, recommend options for
further oversight. SACGT is seeking your input on five main oversight issues
and a number of related questions that are discussed in a document called
A Public Consultation on Oversight of Genetic Tests that is available at the
following Web site: http://www.edc.org/SACGT/index.htm. SACGT would
welcome hearing from you on these important issues.  In order for SACGT
to consider your comments, please submit them by January 31, 2000.

Issue 2:  Call for public comments on the proposed health privacy rule.

The statutory deadline for Congress to enact legislation on this was
August 21, 1999.  Absent legislation, HHS has developed its proposed rule.
The proposed Standards for Privacy of Individually Identifiable Health
Information
are based on the Secretary of Health and Human Services' 1997
recommendations
to Congress entitled, Protecting the Confidentiality of Individually
Identifiable
Health Information.  The deadline for submitting comments to the Department
on
the proposed health privacy rule is February 17, 2000.  The NIH, Office of
Science
Policy (OSP) will be developing an NIH response to the proposed rule based
upon
the Institute comments they receive.

For the actual proposed rule and a summary, feel free to refer to the Web
site
located at:  http://aspe.hhs.gov/admnsimp/ . The attached WordPerfect
document provides a nice summary and some frequently asked questions
that are very helpful.

A summary of what the rule would do is located below.

The proposed rule would:
*      allow health information to be used and shared easily for the
        treatment and for payment of health care;
*      allow health information to be disclosed without an individual's
        authorization for certain national priority purposes (such as
research,
        public health and oversight), but only under defined circumstances;
*      require written authorization for use and disclosure of health
information
        for other purposes; and
*      create a set of fair information practices to inform people of how
their
        information is used and disclosed; and ensure that they have access
        to information about them, and require health plans and providers to
        maintain administrative and physical safeguards to protect the
        confidentiality of health information and protect against
unauthorized access.

Issue 3:  Call for public comments on the "Draft NIH Guidelines for Research
Involving
              Human Pluripotent Stem Cells" in the Federal Register.

The purpose of these draft guidelines is to recommend procedures to help
ensure
that NIH-funded research in this area is conducted in an ethical and legal
manner.

You are invited to provide comments on these draft guidelines.  Written
comments
should be received by NIH on or before January 31, 2000.  Please feel free
to forward
the guidelines to others or to pass on the Web address for the Federal
Register notice:
http://www.nih.gov/news/stemcell/draftguidelines.htm


Jennifer E. Gorman
NIH Public Liaison and COPR Coordinator
Office of Communications and Public Liaison
Office of the Director, NIH
301-435-4448

Charles T. Meyer, M.D.
Middleton(Madison) WI
[log in to unmask]