25752 Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Notices 

DATES: The meeting will take place 

Thursday, June 25, 2009, from 9 a.m. to 

3 p.m., ET; and Friday, June 26, 2009, 

from 9 a.m. to 11:45 a.m., ET. 

ADDRESSES: The Ritz-Carlton, 

Washington, DC, 1150 22nd Street, NW., 

Washington, DC 20037. Phone 202–835– 

0500. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Diane M. Gianelli, Director of 

Communications, The President’s 

Council on Bioethics, 1425 New York 

Avenue, NW., Suite C100, Washington, 

DC 20005. Telephone: 202/296–4669. Email: info@bioethics.gov. Web site: 

http://www.bioethics.gov. 

SUPPLEMENTARY INFORMATION: The 

meeting agenda will be posted at 

http://www.bioethics.gov. The Council 

encourages public input, either in 

person or in writing. At this meeting, 

interested members of the public may 

address the Council, beginning at 11:30 

a.m., on Friday, June 26. Comments are 

limited to no more than five minutes per 

speaker or organization. As a courtesy, 

please inform Ms. Diane M. Gianelli, 

Director of Communications, in advance 

of your intention to make a public 

statement, and give your name and 

affiliation. To submit a written 

statement, mail or e-mail it to Ms. 

Gianelli at one of her contact addresses 

given above. 

Dated: May 18, 2009. 

F. Daniel Davis, 

Executive Director, The President’s Council 

on Bioethics. 

[FR Doc. E9–12538 Filed 5–28–09; 8:45 am] 

BILLING CODE 4154–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0215] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information provisions 

of the final rule, ‘‘Beverages: Bottled 

Water,’’ published elsewhere in this 

issue of the Federal Register, which 

requires both domestic and foreign 

bottled water manufacturers that sell 

bottled water in the United States to 

maintain records of Escherichia coli 

testing and corrective measures, in 

addition to existing recordkeeping 

requirements. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 28, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Recordkeeping Requirements for 

Microbiological Testing and Corrective 

Measures for Bottled Water—21 CFR 

129.35(a)(3)(i), 129.80(g), and 129.80(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, follow-up 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 (§ 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. 

FDA estimates the burden of this 

collection of information as follows: 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Notices 25753 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours 

per Record Total Hours 

§§ 129.35(a)(3)(i) and 

129.80(h) 

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) 

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 7 .5 0.25 2 

§ 129.80(g) and (h) 95 (bottlers testing finished product only) 3 285 0.08 23 

Total Annual Burden 179 

1There are no capital costs or operating costs associated with this collection of information. 

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 

follow-up 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 follow-up 

test for E. coli. 

FDA expects that recordkeeping for 

the follow-up 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: May 18, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12493 Filed 5–26–09; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10078] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Matching Grants 

to States for the Operation of High Risk 

Pools; Use: CMS is requiring this 

information as a condition of eligibility 

for grants that were authorized in the 

Trade Act of 2002, the Deficit Reduction 

Act of 2005 and the State High Risk Pool 

Funding Extension Act of 2006. The 

information is necessary to determine if 

a state applicant meets the necessary 

eligibility criteria for a grant as required 

by law. The respondents will be States 

that have a high risk pool as defined in 

sections 2741, 2744, or 2745 of the 

Public Health Service Act. The grants 

will provide funds to States that incur 

losses in the operation of high risk 

pools. High risk pools are set up by 

States to provide health insurance to 

individuals that cannot obtain health 

insurance in the private market because 

of a history of illness; Form Numbers: 

CMS–10078 (OMB#: 0938–0887); 

Frequency: Recordkeeping, Reporting— 

Occasionally; Affected Public: State, 

Local and Tribal Governments; Number 

of Respondents: 31; Total Annual 

Responses: 31; Total Annual Hours: 

1,240. (For policy questions regarding 

this collection contact Paul Scholz at 

410–786–6178. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

mstockstill on PROD1PC66 with NOTICES