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

25754 Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Notices 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by July 28, 2009: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number (CMS–10078), Room 

C4–26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: May 21, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–12530 Filed 5–28–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–643 and CMS– 

359/360] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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), Department of Health 

and Human Services, 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 function; 

(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 of a currently 

approved collection; Title of 

Information Collection: Hospice Survey 

and Deficiencies Report; Use: In order to 

participate in the Medicare program, a 

hospice must meet certain Federal 

health and safety conditions of 

participation. This form is used by State 

surveyors to record data about a 

hospice’s compliance with these 

conditions of participation in order to 

initiate the certification or 

recertification process. Form Number: 

CMS–643 (OMB#: 0938–0379); 

Frequency: Reporting—Yearly; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

3377; Total Annual Responses: 1130; 

Total Annual Hours: 1130. (For policy 

questions regarding this collection 

contact Kim Roche at 410–786–3524. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Comprehensive 

Outpatient Rehabilitation Facility 

(CORF) Eligibility and Survey Forms 

and Information Collection 

Requirements at 42 CFR 485.54 through 

485.66; Use: In order to participate in 

the Medicare program as a CORF, 

providers must meet Federal conditions 

of participation. The certification form 

is needed to determine if providers meet 

at least preliminary requirements. The 

survey form is used to record provider 

compliance with the individual 

conditions and report findings to CMS. 

Form Number: CMS–359/360/R–55 

(OMB#: 0938–0267); Frequency: 

Reporting—Occasionally; Affected 

Public: Private Sector: Business or other 

for-profits; Number of Respondents: 

476; Total Annual Responses: 60; Total 

Annual Hours: 223,285. (For policy 

questions regarding this collection 

contact Georgia Johnson at 410–786– 

6859. 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 

address 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on June 29, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: May 21, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–12529 Filed 5–28–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; Heart, Lung, and 

Blood Program Project Review Committee. 

Date: June 18, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Jeffrey H. Hurst, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7208, 

Bethesda, MD 20892–7924, 301–435–0303, 

hurstj@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: May 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–12583 Filed 5–28–09; 8:45 am] 

BILLING CODE 4140–01–P 

mstockstill on PROD1PC66 with NOTICES