[Ip-health] KEI asks NIST to extend comment period on their Draft Green Paper on ROI

Luis Gil Abinader luis.gil.abinader at keionline.org
Wed Feb 20 13:06:46 PST 2019

Today KEI asked the Department of Commerce National Institute of Standards
(NIST) to publish a notice in the Federal Register inviting comments on
their Special Publication 1234, Draft Green Paper on Return on Public
Investment, with an extended deadline.

The text of the letter sent today is available below.


February 20, 2019

Walter G. Copan
Under Secretary of Commerce for Standards
and Technology and NIST Director
100 Bureau Drive
Gaithersburg, MD 20899

Via email: walter.copan at nist.gov

Dear Walter G. Copan:

On December 6, 2018, the Department of Commerce National Institute of
Standards (NIST) published a draft green paper (NIST Special Publication
1234) titled, “Return on Investment Initiative for Unleashing American
Innovation.” The draft green paper is 135 pages long, with 313 footnotes,
and 8 pages of references. Some of the proposals in this document are
designed to narrow and even eliminate important safeguards in the Bayh-Dole
Act, and in particular, to protect companies that sell expensive drugs,
vaccines, diagnostic tests and gene- and cell-treatments like CAR T from
obligations to ensure products are affordable and accessible.

According to an initial press release, the deadline to file feedback or
comments on the draft green paper was January 9, 2019. NIST did not provide
a notice in the Federal Register, but only on its web page.

Between the publication of the draft green paper and this original deadline
to file comments were 22 work days, and two public holidays: Christmas and
New Year’s Day. This gave the public a very limited window to study and
comment on a long and technical draft green paper that proposes to
eliminate key safeguards provided under the Bayh-Dole Act.

Furthermore, NIST was affected by the lapse in federal appropriations that
occurred between December 22, 2018 and January 25, 2019, and during that
period the draft green paper was not available at the NIST website.

Knowledge Ecology International (KEI) requested an extension of the
deadline to file comments on the green paper due to the lapse in federal
appropriations. KEI did not receive a response from NIST regarding this
request for a deadline extension.

On February 19, 2019, KEI wrote an additional email to several co-authors
of the paper asking whether the deadline to file comments had been
extended. Chuck Na from the NIST Technology Partnerships Office replied on
the same day stating that the deadline to file comments had been extended
to February 5, 2019, and that this extension was announced on the following
website: nist.gov/tpo/return-investment-roi-initiative That website
currently says that it was “updated February 06, 2019,” and as of today the
deadline extension notice does not seem to be available. This deadline
extension was not directly communicated to KEI nor presumably to other
organizations, and added merely 7 more work days to the comment period.

The timing of the original notice, the lack of information during the
government shutdown period, and the lack of information about the deadline
extension severely limited the public’s ability to file comments on the
draft green paper.

We request the NIST publish a notice in the Federal Register to invite
comments on the draft green paper, with an extended deadline for comment.


Luis Gil Abinader
Knowledge Ecology International

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