56898 Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices 

or other forms of information 

technology to minimize the information 

collection burden. 

Darius Taylor, 

Deputy Information Collection Clearance 

Officer. 

[FR Doc. 2013–22450 Filed 9–13–13; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10371] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Center for Medicare and 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare and 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 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. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

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

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. 

This is necessary to ensure compliance 

with an initiative of the Administration. 

We are requesting an emergency review 

under 5 CFR Part 1320(a)(2)(i) because 

public harm is reasonably likely to 

result if the normal clearance 

procedures are followed. The approval 

of the data collection tools for outcomes 

and operational metrics is essential to 

ensuring that State-based Marketplaces 

provide substantive operational and 

monitoring data to CMS in a uniform 

format from the beginning of the 

enrollment period, October 1, 2013. 

Without an emergency clearance 

process, systematic data collection 

would not begin until well into the open 

enrollment period, and states would 

have to delay critical steps to integrating 

this reporting into their information 

systems. Without consistent data, we 

will be limited in our ability to 

effectively track states’ progress and 

identify problems during this crucial 

early implementation period. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Cooperative 

Agreement to Support Establishment of 

State-Operated Health Insurance 

Exchanges; Use: All States (including 

the 50 States, consortia of States, 

Territories, and the District of Columbia 

herein referred to as States) that 

received a State Planning and 

Establishment Grant for Affordable Care 

Act’s (ACA) Exchanges are eligible for 

the Cooperative Agreement to Support 

Establishment of State Operated 

Insurance Exchanges. Section 1311 of 

the Affordable Care Act offers the 

opportunity for each State to establish 

an Exchange [now referred to as 

Marketplace], and provides for grants to 

States for the planning and 

establishment of these Exchanges. Given 

the innovative nature of Exchanges and 

the statutorily-prescribed relationship 

between the Secretary and States in 

their development and operation, it is 

critical that the Secretary work closely 

with States to provide necessary 

guidance and technical assistance to 

ensure that States can meet the 

prescribed timelines, Federal 

requirements, and goals of the statute. 

In order to provide appropriate and 

timely guidance and technical 

assistance, the Secretary must have 

access to timely, periodic information 

regarding State progress. Consequently, 

the information collection associated 

with these grants is essential to 

facilitating reasonable and appropriate 

federal monitoring of funds, providing 

statutorily-mandated assistance to States 

to implement Exchanges in accordance 

with Federal requirements, and to 

ensure that States have all necessary 

information required to proceed, such 

that retrospective corrective action can 

be minimized. 

The submitted revision adds lists and 

suggested data reporting formats for 

Outcomes and Operational Metrics to 

states’ data collection requirements; we 

will use the resulting data to evaluate 

Marketplace performance and overall 

effectiveness of the ACA. Key areas of 

measurement are the effectiveness of 

eligibility determination and enrollment 

processes, impact on affordability for 

consumers, and the effect of 

Marketplace participation on health 

insurances markets. Furthermore, these 

metrics facilitate actionable feedback 

and technical assistance to States for 

quality improvement efforts during the 

critical early period of operations. This 

funding opportunity was first released 

on January 20, 2011. Form Number: 

CMS–10371(OCN: 0938–1121); 

Frequency: Occasionally; Affected 

Public: State, Local or Tribal 

governments; Number of Respondents: 

40; Total Annual Responses: 1,475; 

Total Annual Hours: 64,695. (For policy 

questions regarding this collection 

contact Christina Daw at 301–492– 

4181.) 

We are requesting OMB review and 

approval of this collection by September 

23, 2013, with a 180-day approval 

period. Written comments and 

recommendation will be considered 

from the public if received by the 

individuals designated below by the 

noted deadline below. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’s 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. 

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 September 23, 2013: 

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 (CMS–10371), 

Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 

21244–1850 and, 

OMB Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, New Executive Office 

Building, Room 10235, Washington, 

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Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices 56899 

DC 20503, Fax Number: (202) 395– 

6974. 

Dated: September 12, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–22517 Filed 9–13–13; 8:45 am] 

BILLING CODE 4120–01–P 

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: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. 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, 

PRAStaff@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. 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

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Operating and 

maintenance 

costs 

Request for CLIA categorization .............. 60 15 900 1 900 $46,800 

1There 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 × 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0001] 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Blood Products 

Advisory Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

Agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on November 1, 2013, from 8 a.m. to 4:30 

p.m. 

Location: FDA Fishers Lane Building, 5630 

Fishers Lane, rm. 1066, Rockville, MD 20857. 

For those unable to attend in person, the 

meeting will also be Web cast. The Web cast 

will be available at the following link: http:// 

fda.yorkcast.com/webcast/Viewer/?peid=

18390c01dfff405681afa644b1837e5a1d. 

Contact Person: Bryan Emery or Pearline 

Muckelvene, Center for Biologics Evaluation 

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