**Division of Dockets Management (HFA-305)**

Food and Drug Administration

Room 1061

5630 Fishers Lane

Rockville, MD 20852

March 16, 2007

Ref: **Docket No. 2006D-0526**

> Draft Guidance entitled, "E15 Terminology in Pharmacogenomics"

Abbott Laboratories is pleased to provide the following comments on the
draft guidance for industry entitled, "E15 Terminology in
Pharmacogenomics," published in the Federal Register on January 8, 2007.

1.  **Section 2.1.2 ("Additional Information") contains a partial list
    of DNA characteristics.**

Please consider adding "haplotypes" to this list.

2.  **The third, fourth, and fifth sentences of Section 2.3 ("CATEGORIES
    FOR GENOMIC DATA AND SAMPLES CODING") read, "There are four general
    categories of coding: identified, coded, anonymised and anonymous.
    Coded data or samples can be single or double coded. The
    implications of using a specific data and sample coding category
    should be considered in the design of PGx and PGt research
    studies."**

> For clarity, we request you revise these sentences to read, "There are
> four general categories of coding: identified, coded, anonymized and
> anonymous. Coded data or samples can be single or double coded. Coded
> data and samples may be rendered anonymized and are reclassified as
> such if the link between the subjects' identifiers and the unique
> codes are deleted. The implications of using a specific data and
> sample coding category should be considered in the design of PGx and
> PGt research studies."

3.  **The fourth and fifth sentences of Section 2.3.1 ("Identified Data
    and Samples") read, "Identified data and samples coding offers
    privacy protection similar to general healthcare confidentiality in
    everyday medical practice. Identified data and sample coding are
    generally not considered appropriate for purposes of clinical trials
    in drug development.\"**

> Please revise these sentences to read, "Identified data and samples
> offer privacy protection similar to general healthcare confidentiality
> in everyday medical practice. In contrast, identified data and samples
> are generally not considered appropriate for purposes of clinical
> trials in drug development."

The following minor editorial recommendations are also included for your
consideration:

4.  **The next to the last sentence in Section 2.3.2.2 ("Double-Coded
    Data and Samples") reads, "The use of the second code provides
    additional confidentiality and privacy protection for subjects over
    that of single coded.**

> For clarity, please revise this section to read, "The use of the
> second code provides additional confidentiality and privacy protection
> for subjects, compared to the use of a single code."

5.  **The first sentence in Section 2.3.3 ("Anonymised Data and
    Samples") reads, "Anonymised data and samples are initially single
    or double coded but then the link between the subjects identifiers
    and the unique code(s) are subsequently deleted."**

> Please correct the apparent grammatical error in this sentence by
> revising it to read, "Anonymized data and samples are initially single
> or double coded, but the link between the subjects' identifiers and
> the unique code(s) is subsequently deleted."

6.  **The second sentence of Section 2.3.4 "Anonymous Data and Samples"
    reads, "In some instances only limited clinical data is associated
    with anonymous samples."**

> Please correct the apparent grammatical error in this sentence by
> revising it to read, "In some instances only limited clinical data are
> associated with anonymous samples."

7.  **Section 2.1.2 ("Additional Information"), item 4, reads, "The
    definition for a genomic biomarker does not include the measurement
    and characterisation of proteins or low molecular weight
    metabolites."**

> Please revise this sentence to read, "The definition of a genomic
> biomarker does not include the measurement and characterization of
> proteins or low molecular weight metabolites."

8.  Please use US spelling throughout the document.

We thank the Agency for its consideration of our comments. Should you
have any questions, please contact Ms. Melodi McNeil, Director,
Regulatory Intelligence, at 301-255-0085, x105 or by FAX at
301-255-0090.

Sincerely,

Douglas L. Sporn

Divisional Vice-President

Regulatory Intelligence

Global Pharmaceutical Regulatory Affairs