This collection
is approved on the condition that ATSDR provide to OMB the
following information within the timeperiods specified below. OMB
must receive this information in order to approve the collection
upon next review. By Sept. 1, 1998: Item#1: Page 33 of the
Supporting Statement speaks of a validation study currently
underway within the agency. Page 19 of the 1995 clearance package
also mentions the study. Please provide the most current version of
this study, including but not limited to: research plans,
protocols, data, hypothesis tests performed, and the results of
these tests. Item #2: Please submit a copy of each of the available
reports listed on page 25 of the Supporting Statement (include all
registries except TCE). Item #3: Please provide copies of any
documents produced to summarize the several meetings and reviews
concerning the exposure registry that occurred between 1992 and the
present (referred to on pages 15-16 of the Supporting Statement).
Also provide the results of these events, particularly: the NER
Review Panel convened in 1992; the subregistry Technical Assistance
Panel convened in 1993; and the updates of the NER/Iodine 131
subregistry at the Hanford Health Effects Subcommittee. Item #4:
Page 26 of the Supporting Statement describes an array of
comparisons that ATSDR uses to interpret the registry data. Please
provide copies of these statistical reports. By January 1, 1999:
Item #5: Page two of the National Exposure Registry Policies and
Procedures Manual (Revised) (henceforth NER Manual) discusses the
criteria for determining that an individual has been exposed.
Please provide a list of documented exposure pathways of concern
(e.g., drinking water, soil, air, etc.) for each subregistry. Item
#6: Page six of the NER manual outlines the potential for
confounding variables. In addition, page 17 of the NER Manual
claims that one of the secondary site-selection criteria examines
the number of secondary or potentially confounding contaminants.
For each subregistry, please identify what environmental and
biomonitoring data are collected for the following purposes: (1) To
control for exposure to other contaminants from the same source at
the selected sites (e.g., level of coincident benzene exposure from
the same source in the trichloroethylene subregistry); and (2) To
control for exposure to the same or different contaminants from
other sources (e.g., in the trichloroethylene subregistry, benzene
and/or trichloroethylene exposure from other sources). Item #7:
Page eight of the NER Manual discusses ATSDR's attempts to identify
and list, as part of the subregistry, all available information
relative to that site. Please provide this background information
for each of the current subregistries. Item #8: Pages 12 and 13 of
the NER Manual list the ranking criteria for chemical selection:
extent of contamination, toxicity, potential for human exposure,
data gaps, and registry potential for filling those gaps. Please
submit copies of the documents upon which ATSDR based its decision
to include those contaminants currently in the NER program, those
contaminants that have been considered but rejected, and those
contaminants that ATSDR would like to include in the future. Item
#9: Page 14 of the NER Manual describes the site-identification
process. Step 2 states that ATSDR conducts a public health
assessment for each of the potential sites using the following
primary criteria: documented contamination of media (one or more),
levels of contamination, competed exposure pathway survey, length
of exposure, and size of population potentially exposed. Please
provide a document that clearly explains the findings associated
with the Step 2 criteria for each of the selected sites. By January
1, 2000: Item #10: Pages 19 and 20 of the NER Manual discuss the
procedures for obtaining the medical records of the participants.
Please identify and explain the procedures that ATSDR has used to
ensure that information collected was confirmed by a health care
provider. For each subregistry, please indicate (a) the percentage
of registrants for whom such information was confirmed by a health
care provider, and (b) the percentage that was validated by medical
records. In addition, please report (c) the proportion of
self-reported health conditions that could not be confirmed by a
health care provider, and (d) the proportion of the claims that
could not be validated by medical records. Item #11: According to
page 28 of the Supporting Statement, the purpose of the NER is to
facilitate scientific research through the creation of large,
accurate, relevant data files. ATSDR then compares the data to
national norms (National Health Interview Survey) to identify
potential health problems. Please provide the national norms that
ATSDR uses for comparision purposes for all relevant exposure data
for each subregistry. By July 1, 2000: Item #12: Page four of the
Supporting Statement lists ATSDR's goals for the exposure registry.
Please identify the GPRA performance measures that ATSDR uses to
quantify each of these goals, and an evaluation of the agency's
progress toward achieving them. Item #13: Page 10 of the Supporting
Statement states that the data have proven sufficient for
hypothesis testing and generating. Please submit a complete list of
the hypotheses known to the agency that have been either generated
or tested using the NER data. If these expected dates prove
unreasonable, please contact the desk officer at (202) 395-3087.
For further clarification of these requests, see attached
document.
Inventory as of this Action
Requested
Previously Approved
11/30/2001
11/30/2001
06/30/1998
11,667
0
15,150
5,833
0
6,320
0
0
0
This request represents the fourth
successive request by ATSDR of this information collection and
instruments. The National Exposure Registry is an effort to provide
basic information concerning the impact of toxic substances on the
health of the general population by analyzing, over time, any
changes in health status of those individuals documented to have
likely exposures to selected toxic substances in the
environment.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
National Exposure Registry