Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices 4151 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) has 

pioneered research on the toxicological 

properties and characteristics of 

nanoparticles. This research has 

involved characterizing occupationally 

relevant nanoparticles for predicting 

whether these particles pose a risk of 

adverse health effects and for providing 

guidance on controlling workplace 

exposures. In September 2005, NIOSH 

developed a strategic plan to further 

guide the Institute in identifying and 

prioritizing nanotechnology research. In 

2009 this strategic plan [http:// 

www.cdc.gov/niosh/docs/2010-105] was 

updated based on knowledge gained 

from results of ongoing NIOSH research 

[see Progress Toward Safe 

Nanotechnology in the Workplace; A 

Report from the NIOSH Nanotechnology 

Research Center http://www.cdc.gov/ 

niosh/docs/2007-123/] and from the 

public and stakeholder input. NIOSH 

would like to build on the 

accomplishments of ongoing research 

[http://www.cdc.gov/niosh/docs/2013- 

101/ and http://www.cdc.gov/niosh/ 

docs/2010-104/] to develop strategic 

research goals and objectives for 

nanotechnology occupational safety and 

health research through 2016. NIOSH 

has identified 10 critical research areas 

for nanotechnology research and 

communication. These 10 critical 

research areas are (1) Toxicity and 

internal dose, (2) measurement 

methods, (3) exposure assessment, (4) 

epidemiology and surveillance, (5) risk 

assessment, (6) engineering controls and 

personal protective equipment (PPE), (7) 

fire and explosion safety, (8) 

recommendations and guidance, (9) 

global collaborations, and (10) 

applications. 

NIOSH is considering focusing the 

overarching strategic research goals for 

these critical areas on 5 key objectives: 

(1) Increase understanding of new 

hazards and related health risks to 

nanomaterial workers; (2) Expand 

understanding of the initial hazard 

findings on engineered nanomaterials; 

(3) Support the creation of guidance 

materials to inform nanomaterial 

workers, employers, health 

professionals, regulatory agencies, and 

decision-makers about hazards, risks, 

and risk management approaches; (4) 

Support epidemiologic studies for 

nanomaterial workers, including 

medical and exposure studies; and 5) 

Assess and promote national adherence 

with risk management guidance. 

NIOSH requests public input to 

address the following: 

(1) What is the basis or rationale for 

priorities that NIOSH should give for 

studies of toxicity evaluation and/or 

workplace exposure characterization for 

engineered nanoparticles? 

(2) What rationale can be provided for 

recommending needs and types of 

technical and educational guidance 

materials? 

Dated: January 14, 2013. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2013–00994 Filed 1–17–13; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3278–N] 

Medicare Program; Request for 

Information on Hospital and Vendor 

Readiness for Electronic Health 

Records Hospital Inpatient Quality 

Data Reporting; Extension of Comment 

Period 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information; 

extension of the comment period. 

SUMMARY: This notice extends the 

comment period for a request for 

information (RFI) which was published 

in the January 3, 2013 Federal Register 

(78 FR 308). The RFI requests that 

hospitals, electronic health record (EHR) 

vendors, and other interested parties 

respond to questions regarding their 

readiness to conduct electronic 

reporting of certain patient-level data 

under the Hospital Inpatient Quality 

Reporting (IQR) Program using the 

Quality Reporting Document 

Architecture (QRDA) Category I. The 

comment period for the RFI, which 

would have ended on January 22, 2013, 

is extended to February 1, 2013. 

DATES: The comment period for the 

request for information published in the 

January 3, 2013 Federal Register (78 FR 

308) is extended to February 1, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–3278–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3278–NC, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3278–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this 

document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Maria Harr, (410) 789–6710. 

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4152 Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices 

SUPPLEMENTARY INFORMATION: In the 

January 3, 2013 Federal Register (78 FR 

308), we published a document 

requesting information from hospitals, 

electronic health record (EHR) vendors, 

and other interested parties regarding 

hospital readiness to begin 

electronically reporting certain patientlevel data under the Hospital Inpatient 

Quality Reporting (IQR) Program using 

the Quality Reporting Document 

Architecture (QRDA) Category I 

beginning with calendar year 2014 

discharges. 

Because of the scope of the requested 

information and inquiries received from 

several industry and professional 

organizations/associations regarding the 

need for additional time to respond to 

our request, we are extending the 

comment period until February 1, 2013. 

Dated: January 15, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–01142 Filed 1–16–13; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0333] 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice invites comments on 

the procedure by which both domestic 

and foreign bottled water manufacturers 

that sell bottled water in the United 

States maintain records of 

microbiological testing and corrective 

measures, in addition to existing 

recordkeeping requirements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 19, 2013. 

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: 

Domini Bean, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400T, Rockville, MD 20850, 

domini.bean@fda.hhs.gov. 

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, 

including each proposed extension of an 

existing 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) 

(OMB Control Number 0910–0658)— 

Extension 

The bottled water regulations in parts 

129 and 165 (21 CFR parts 129 and 165) 

require 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 Escherichia coli. The 

adulteration provision of the bottled 

water standard (§ 165.110(d)) provides 

that a 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, 

the current good manufacturing practice 

(CGMP) regulations for bottled water in 

part 129 require 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 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: 

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