1. During 2007, all systems are assumed to incur some reading and reporting burden, as described in Part A, Section
4(b)(ii)(a) of this document. See Exhibit 8a for further PWS cost estimation details.
2. Although EPA is not considered a respondent to the UCMR regulations, Agency burdens are shown here to
illustrate the national costs of the program. National totals are shown with and without the Agency costs.
Exhibit B-5: UCMR 2 Per Respondent Burden and Cost Summary (2007-2011)
(corresponds with Exhibit 13)
Burden (hours)/
Cost (dollars)
Small
Systems
Large
Systems
Very Large
Systems
States
EPA
National
Average
with EPA
1
National
Average
without
EPA
Five-Year Total per Respondent
Total # of
Responses Per
Respondent
2.7 3.1
3.6
5.0
n/a
n/a 3.0
Labor Cost Per
Respondent $216
$705
$1,663
$43,816
$3,178,490
$1,783
$1,143
Non-Labor Cost
Per Respondent
$0
$5,241
$21,780
$0 $10,068,694
$7,211
$5,186
Total Cost
(Labor plus
Non-Labor)
$216
$5,946
$23,443
$43,816 $13,247,184
$8,994
$6,330
Total Cost Per
Response
$81 $1,941
$6,517
$8,763
n/a
n/a
$2,093
Total Burden
Per Respondent
7.7
23.8
46.8
800.2
45,760.0
39.5
30.3
Total Burden
Per Response
2.9
7.8
13.0
160.0
n/a
n/a
10.0
Average Annual per Respondent
Ave. # of
Responses Per
Respondent
0.5 0.6
0.7
1.0
n/a
n/a 0.6
B-5

Information Collection Request for UCMR 2
November 2009
Exhibit B-5: UCMR 2 Per Respondent Burden and Cost Summary (2007-2011)
(corresponds with Exhibit 13)
Burden (hours)/
Small
Systems
Large
Systems
Very Large
Systems
States
EPA
National
Average
with EPA
1
National
Average
without
EPA
Cost (dollars)
Labor Cost Per
Respondent
$43
$141
$333
$8,763
$635,698
$357
$229
Non-Labor Cost
Per Respondent
$0
$1,048
$4,356
$0
$2,013,739
$1,442
$1,037
Ave. Cost
(Labor plus
Non-Labor)
$43
$1,189
$4,689
$8,763
$2,649,437
$1,799
$1,266
Ave. Cost Per
Response
$16 $388
$1,303
$1,753
n/a
n/a
$419
Ave. Burden Per
Respondent
1.5 4.8
9.4
160.0
9,152.0
7.9 6.1
Ave. Burden Per
Response
0.6 1.6
2.6
32.0
n/a
n/a
2.0
1. National average burdens and costs differ greatly between the State respondents and the various system
respondents. This should be taken into consideration when looking at the national average with or without EPA.
PWS labor costs were estimated by system size and water source by multiplying estimated burden (as described in
Section 6(a)(i)) for each activity by estimated system labor rates (see Exhibit 6 in Section 6(a)(i)). Non-labor costs
were also estimated by system size and water source, and by multiplying “number of systems” by “number of
sampling points” by “number of required samples” by “lab and shipping fees”. All burden and cost estimation
assumptions for systems and States are described in Section 6(a) and 6(b) in Part A of this document. Average “per
respondent” costs were derived by dividing through by the number of respondents from each category.
B-6


[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Page 56899]
[FR Doc No: 2013-22443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0514]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requests for Clinical
Laboratory Improvement Amendments Categorization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
16, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0607.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Requests for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Categorization--42 CFR 493.17 (OMB Control
Number 0910-0607)--Extension.
    A guidance document entitled ``Guidance for Administrative
Procedures for CLIA Categorization'' was released on May 7, 2008. The
document describes procedures FDA uses to assign the complexity
category to a device. Typically, FDA assigns complexity categorizations
to devices at the time of clearance or approval of the device. In this
way, no additional burden is incurred by the manufacturer because the
labeling (including operating instructions) is included in the
premarket notification (510(k)) or premarket approval application
(PMA). In some cases, however, a manufacturer may request CLIA
categorization even if FDA is not simultaneously reviewing a 510(k) or
PMA. One example is when a manufacturer requests that FDA assign CLIA
categorization to a previously cleared device that has changed names
since the original CLIA categorization. Another example is when a
device is exempt from premarket review. In such cases, the guidance
recommends that manufacturers provide FDA with a copy of the package
insert for the device and a cover letter indicating why the
manufacturer is requesting a categorization (e.g. name change, exempt
from 510(k) review). The guidance recommends that in the correspondence
to FDA the manufacturer should identify the product code and
classification as well as reference to the original 510(k) when this is
available. In the Federal Register of May 22, 2013 (78 FR 30312), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                 Table 1--Estimated Annual Reporting Burden Activity \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                                                         Operating and
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours      maintenance
                                                      respondents       respondent       responses      per  response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for CLIA categorization...................              60               15              900                1              900          $46,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    The number of respondents is approximately 60. On average, each
respondent will request categorizations (independent of a 510(k) or
PMA) 15 times per year. The cost, not including personnel, is estimated
at $52 per hour (52 x 900), totaling $46,800. This includes the cost of
copying and mailing copies of package inserts and a cover letter, which
includes a statement of the reason for the request and reference to the
original 510(k) numbers, including regulation numbers and product
codes. The burden hours are based on FDA familiarity with the types of
documentation typically included in a sponsor's categorization
requests, and costs for basic office supplies (e.g. paper).

    Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22443 Filed 9-13-13; 8:45 am]
BILLING CODE 4160-01-P