Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water, 55557-55558 [E9-25927]
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Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
The estimated annual reporting
burden on industry is 37.35 hours as
shown in table 1 of this document.
Industry estimates it takes about 1/4
hour to submit the application. We
estimate 135 original and supplemental
applications, and voluntary revocations
for a total of 33.75 hours (135
submissions x 1/4 hour). An additional
3.6 hours is added for the rare notice of
opportunity for a hearing to not approve
or revoke an application. Finally, we
estimate 30 hours for maintaining and
retrieving labels as required by 21 CFR
510.305 and shown in table 2 of this
document. We estimated 0.03 hours for
each of the approximately 1,000
licensees. Thus, the total annual burden
for reporting and recordkeeping
requirements is estimated to be 67.35
hours.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25915 Filed 10–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0215]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
Requirements for Microbiological
Testing and Corrective Measures for
Bottled Water
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 November
27, 2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794, email:
JonnaLynn.Capezzuto@fda.hhs.gov.
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.
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water—21 CFR
129.35(a)(3)(i) and 129.80(g) and (h)
FDA has amended its bottled water
regulations in parts 129 and 165 (21
CFR parts 129 and 165) by requiring that
if any coliform organisms are detected
in weekly total coliform testing of
finished bottled water, followup testing
55557
must be conducted to determine
whether any of the coliform organisms
are E. coli. FDA also amended the
adulteration provision of the bottled
water standard (§ 165.110(d)) to indicate
that finished product that tests positive
for E. coli will be deemed adulterated
under section 402(a)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
342(a)(3)). In addition, FDA amended
the Current Good Manufacturing
Practices (CGMP) regulations for bottled
water in part 129 by requiring that
source water from other than a public
water system (PWS) be tested at least
weekly for total coliform. If any coliform
organisms are detected in the source
water, the bottled water manufacturers
are required to determine whether any
of the coliform organisms are E. coli.
Source water found to contain E. coli is
not considered water of a safe, sanitary
quality and would be unsuitable for
bottled water production. Before a
bottler may use source water from a
source that has tested positive for E.
coli, a bottler must take appropriate
measures to rectify or otherwise
eliminate the cause of the
contamination. A source previously
found to contain E. coli will be
considered negative for E. coli after five
samples collected over a 24-hour period
from the same sampling site are tested
and found to be E. coli negative.
Description of Respondents: The
respondents to this proposed
information collection are domestic and
foreign bottled water manufacturers that
sell bottled water in the United States.
In the Federal Register of May 29,
2009 (74 FR 25752 ), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours
per Record
Total Hours
319 (bottlers subject to
source water and finished product testing)
6
1,914
0.08
153
§§ 129.35(a)(3)(i) and
129.80(h)
erowe on DSK5CLS3C1PROD with NOTICES
§§ 129.35(a)(3)(i) and
129.80(h)
2.5 (bottlers conducting
secondary testing of
source water)
5
12
0.08
1
§§ 129.35(a)(3)(i) and
129.80(h)
2.5 (bottlers rectifying contamination)
3
0.25
2
§ 129.80(g) and (h)
95 (bottlers testing finished product only)
3
0.08
23
7.5
285
Total Annual Burden
1There
179
are no capital costs or operating and maintenance costs associated with this collection of information.
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55558
Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
The current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
FDA therefore concludes that any
additional burden and costs in
recordkeeping based on the new testing
requirements for source and finished
bottled water are negligible. FDA
estimates that the labor burden of
keeping records of each test is about 5
minutes per test. FDA also requires
followup testing of source water and
finished bottled water products for E.
coli when total coliform positives occur.
FDA expects that 319 bottlers that use
sources other than PWSs may find a
total coliform positive sample about 3
times per year in source testing and
about 3 times in finished product
testing, for a total of 153 hours of
recordkeeping. In addition to the 319
bottlers, about 95 bottlers that use PWSs
may find a total coliform positive
sample about 3 times per year in
finished product testing, for a total of 23
hours of recordkeeping. Upon finding a
total coliform positive sample, bottlers
will then have to conduct a followup
test for E. coli.
FDA expects that recordkeeping for
the followup test for E. coli will also
take about 5 minutes per test. As shown
in table 1 of this document, FDA
expects that 2.5 bottlers per year will
have to carry out the additional E. coli
testing, with a burden of 1 hour. These
bottlers will also have to keep records
about rectifying the source
contamination, for a burden of 2 hours.
For all expected total coliform testing, E.
coli testing, and source rectification,
FDA estimates a total burden of 179
hours. FDA bases its estimate on its
experience with the current CGMP
regulations.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25927 Filed 10–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; A Generic Submission for
Formative Research, Pretesting, and
Customer Satisfaction of NCI’s
Communication and Education
Resources (NCI)
SUMMARY: Under the provisions of
Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National Cancer
Institute (NCI), the National Institutes of
Health (NIH) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: A Generic
Submission For Formative Research,
Pretesting, and Customer Satisfaction of
NCI’s Communication and Education
Resources. Type of Information
Collection Request: REVISION. Need
and Use of Information Collection: In
order to carry out NCI’s legislative
mandate to educate and disseminate
information about cancer prevention,
detection, diagnosis, and treatment to a
wide variety of audiences and
organizations (e.g., cancer patients, their
families, the general public, health
providers, the media, voluntary groups,
scientific and medical organizations), it
is beneficial for NCI, through its Office
of Communications and Education
(OCE), to pretest NCI communications
strategies, concepts, and messages while
they are under development. This
pretesting, or formative evaluation,
helps ensure that the messages,
communication materials, and
information services created by NCI
have the greatest capacity of being
received, understood, and accepted by
their target audiences. Since NCI’s OCE
also is responsible for the design,
implementation, and evaluation of
education programs over the entire
cancer continuum, and management of
NCI initiatives that address specific
challenges in cancer research and
treatment, it is also necessary to ensure
that customers are satisfied with
programs. This customer satisfaction
research helps ensure the relevance,
utility, and appropriateness of the many
educational programs and products that
OCE and NCI produce. OCE will use a
variety of qualitative (focus groups,
interviews) and quantitative (paper,
phone, in-person, and Web surveys)
methodologies to conduct this formative
and customer satisfaction research,
allowing NCI to: (1) Understand
characteristics (attitudes, beliefs, and
behaviors) of the intended target
audience and use this information in the
development of effective
communication tools and strategies; (2)
use a feedback loop to help refine,
revise, and enhance messages, materials,
products, and programs—ensuring that
they have the greatest relevance, utility,
appropriateness, and impact for/to
target audiences; and (3) expend limited
program resource dollars wisely and
effectively. This package represents the
combination of a currently approved
generic submission, ‘‘Pretesting of NCI’s
Office of Communications Messages,’’
(OMB No. 0925–0046) and a formerly
approved generic submission,
‘‘Customer Satisfaction with
Educational Programs and Products of
the NCI’’ (OMB No. 0925–0526).
Frequency of Response: On occasion.
Affected Public: Individuals or
households; Businesses or other for
profit; Not-for-profit institutions;
Federal Government; State, Local, or
Tribal Government. Type of
Respondents: Adult cancer patients;
members of the public; health care
professionals; researchers;
organizational representatives. The table
below outlines the estimated burden
hours required for a three-year approval
of this generic submission. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
TABLE 1—ESTIMATES FOR BURDEN HOURS FOR THREE YEARS
[Generic study]
Total number
of respondents
erowe on DSK5CLS3C1PROD with NOTICES
Survey method
Frequency of
response
Minutes/hour
per response
Total burden
hours
Focus Groups ..................................................................................................
Individual In-Depth Interviews (Typically longer than 15 minutes, includes
Web site usability testing) ............................................................................
Brief Interviews (Typically less than 5 minutes) ..............................................
Surveys (Web, phone, in-person, paper-and-pencil) .......................................
900
1
90/60 (1.5)
1,350.00
600
19,000
12,500
1
1
1
45/60 (.75)
10/60 (.17)
10/60 (.17)
450.00
3,166.67
2,083.33
Totals ........................................................................................................
33,000
........................
........................
7,050.00
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]]>Agencies
[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55557-55558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0215]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recordkeeping
Requirements for Microbiological Testing and Corrective Measures for
Bottled Water
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
November 27, 2009.
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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Recordkeeping Requirements for Microbiological Testing and
Corrective Measures for Bottled Water.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794, e-mail:
JonnaLynn.Capezzuto@fda.hhs.gov.
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.
Recordkeeping Requirements for Microbiological Testing and Corrective
Measures for Bottled Water--21 CFR 129.35(a)(3)(i) and 129.80(g) and
(h)
FDA has amended its bottled water regulations in parts 129 and 165
(21 CFR parts 129 and 165) by requiring that if any coliform organisms
are detected in weekly total coliform testing of finished bottled
water, followup testing must be conducted to determine whether any of
the coliform organisms are E. coli. FDA also amended the adulteration
provision of the bottled water standard (Sec. 165.110(d)) to indicate
that finished product that tests positive for E. coli will be deemed
adulterated under section 402(a)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, FDA amended the
Current Good Manufacturing Practices (CGMP) regulations for bottled
water in part 129 by requiring that source water from other than a
public water system (PWS) be tested at least weekly for total coliform.
If any coliform organisms are detected in the source water, the bottled
water manufacturers are required to determine whether any of the
coliform organisms are E. coli. Source water found to contain E. coli
is not considered water of a safe, sanitary quality and would be
unsuitable for bottled water production. Before a bottler may use
source water from a source that has tested positive for E. coli, a
bottler must take appropriate measures to rectify or otherwise
eliminate the cause of the contamination. A source previously found to
contain E. coli will be considered negative for E. coli after five
samples collected over a 24-hour period from the same sampling site are
tested and found to be E. coli negative.
Description of Respondents: The respondents to this proposed
information collection are domestic and foreign bottled water
manufacturers that sell bottled water in the United States.
In the Federal Register of May 29, 2009 (74 FR 25752 ), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 319 (bottlers 6 1,914 0.08 153
129.35(a)(3)(i) subject to
and 129.80(h) source water
and finished
product
testing)
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 2.5 (bottlers 5 12 0.08 1
129.35(a)(3)(i) conducting
and 129.80(h) secondary
testing of
source water)
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 2.5 (bottlers 3 7.5 0.25 2
129.35(a)(3)(i) rectifying
and 129.80(h) contamination)
----------------------------------------------------------------------------------------------------------------
Sec. 129.80(g) 95 (bottlers 3 285 0.08 23
and (h) testing
finished
product only)
----------------------------------------------------------------------------------------------------------------
Total Annual Burden 179
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 55558]]
The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. FDA
therefore concludes that any additional burden and costs in
recordkeeping based on the new testing requirements for source and
finished bottled water are negligible. FDA estimates that the labor
burden of keeping records of each test is about 5 minutes per test. FDA
also requires followup testing of source water and finished bottled
water products for E. coli when total coliform positives occur. FDA
expects that 319 bottlers that use sources other than PWSs may find a
total coliform positive sample about 3 times per year in source testing
and about 3 times in finished product testing, for a total of 153 hours
of recordkeeping. In addition to the 319 bottlers, about 95 bottlers
that use PWSs may find a total coliform positive sample about 3 times
per year in finished product testing, for a total of 23 hours of
recordkeeping. Upon finding a total coliform positive sample, bottlers
will then have to conduct a followup test for E. coli.
FDA expects that recordkeeping for the followup test for E. coli
will also take about 5 minutes per test. As shown in table 1 of this
document, FDA expects that 2.5 bottlers per year will have to carry out
the additional E. coli testing, with a burden of 1 hour. These bottlers
will also have to keep records about rectifying the source
contamination, for a burden of 2 hours. For all expected total coliform
testing, E. coli testing, and source rectification, FDA estimates a
total burden of 179 hours. FDA bases its estimate on its experience
with the current CGMP regulations.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25927 Filed 10-27-09; 8:45 am]
BILLING CODE 4160-01-S
