42516 Federal Register / Vol. 79, No. 140 / Tuesday, July 22, 2014 / Notices 

Agency for Healthcare Research and 

Quality, 540 Gaither Road, Rockville, 

Maryland 20850. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Zimmerman, Designated 

Management Official, at the Agency for 

Healthcare Research and Quality, 540 

Gaither Road, Rockville, Maryland 

20850, (301) 427–1456. For press-related 

information, please contact Alison Hunt 

at (301) 427–1244. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Diversity Management 

on (301) 827–4840, no later than Friday, 

July 11, 2014. The agenda, roster, and 

minutes are available from Ms. Bonnie 

Campbell, Committee Management 

Officer, Agency for Healthcare Research 

and Quality, 540 Gaither Road, 

Rockville, Maryland 20850. Ms. 

Campbell’s phone number is (301) 427– 

1554. 

SUPPLEMENTARY INFORMATION: 

I. Purpose 

The National Advisory Council for 

Healthcare Research and Quality is 

authorized by Section 941 of the Public 

Health Service Act, 42 U.S.C. 299c. In 

accordance with its statutory mandate, 

the Council is to advise the Secretary of 

the Department of Health and Human 

Services and the Director, Agency for 

Healthcare Research and Quality 

(AHRQ), on matters related to AHRQ’s 

conduct of its mission including 

providing guidance on (A) priorities for 

health care research, (B) the field of 

health care research including training 

needs and information dissemination on 

health care quality and (C) the role of 

the Agency in light of private sector 

activity and opportunities for public 

private partnerships. 

The Council is composed of members 

of the public, appointed by the 

Secretary, and Federal ex-officio 

members specified in the authorizing 

legislation. 

II. Agenda 

On Friday, July 25, 2014, there will be 

a subcommittee meeting for the National 

Healthcare Quality and Disparities 

Report scheduled to begin at 7:30 a.m. 

The subcommittee meeting is open the 

public. The Council meeting will 

convene at 8:30 a.m., with the call to 

order by the Council Chair and approval 

of previous Council summary notes. The 

meeting is open to the public. The 

meeting will begin with the AHRQ 

Director presenting an update on 

current research, programs, and 

initiatives. Following the Director’s 

Update, the agenda will include a 

discussion on Delivery System Reform 

and updates from the Office of the 

National Coordinator for Health 

Information Technology (ONC) and 

from AHRQ on Health Information 

Technology. The final agenda will be 

available on the AHRQ Web site at 

www.AHRQ.gov no later than Friday, 

July 18, 2014. 

Dated: July 3, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–16668 Filed 7–21–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–718–721] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the 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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by August 21, 2014: 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR, Email: 

OIRA_submission@omb.eop.gov 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

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

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Business 

Proposal Forms for Quality 

Improvement Organizations (QIOs); Use: 

The submission of proposal information 

by current quality improvement 

associations (QIOs) and other bidders, 

on the appropriate forms, will satisfy 

our need for meaningful, consistent, and 

verifiable data with which to evaluate 

contract proposals. We use the data 

collected on the forms associated with 

this information collection request to 

negotiate QIO contracts. We will be able 

to compare the costs reported by the 

QIOs on the cost reports to the proposed 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 140 / Tuesday, July 22, 2014 / Notices 42517 

costs noted on the business proposal 

forms. Subsequent contract and 

modification negotiations will be based 

on historic cost data. The business 

proposal forms will be one element of 

the historical cost data from which we 

can analyze future proposed costs. In 

addition, the business proposal format 

will standardize the cost proposing and 

pricing process among all QIOs. With 

well-defined cost centers and line items, 

proposals can be compared among QIOs 

for reasonableness and appropriateness. 

Form Number: CMS–718–721 (OMB 

control number: 0938–0579); Frequency: 

Annually; Affected Public: Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

20; Total Annual Responses: 20; Total 

Annual Hours: 1,000. (For policy 

questions regarding this collection 

contact Clarissa Whatley at 410–786– 

7154.) 

Dated: July 16, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–17137 Filed 7–21–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0913] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; 513(g) Request for 

Information 

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 solicits comments on 

the information collection burden 

estimate for requests for a written 

statement from FDA regarding the 

classification and regulatory 

requirements that may be applicable to 

a particular device (513(g) requests). 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 22, 2014. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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. 

513(g) Request for Information—(OMB 

Control Number 0910–0705)—Extension 

Section 513(g) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360c(g)) provides a means for 

obtaining the Agency’s views about the 

classification and regulatory 

requirements that may be applicable to 

a particular device. Section 513(g) 

provides that within 60 days of the 

receipt of a written request of any 

person for information respecting the 

class in which a device has been 

classified or the requirements applicable 

to a device under the FD&C Act, the 

Secretary of Health and Human Services 

shall provide such person a written 

statement of the classification (if any) of 

such device and the requirements of the 

FD&C Act applicable to the device. 

The guidance document entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff FDA and 

Industry Procedures for Section 513(g) 

Requests for Information Under the 

Federal Food, Drug, and Cosmetic Act’’ 

establishes procedures for submitting, 

reviewing, and responding to requests 

for information respecting the class in 

which a device has been classified or 

the requirements applicable to a device 

under the FD&C Act that are submitted 

in accordance with section 513(g) of the 

FD&C Act. FDA does not review data 

related to substantial equivalence or 

safety and effectiveness in a 513(g) 

request for information. FDA’s 

responses to 513(g) requests for 

information are not device classification 

decisions and do not constitute FDA 

clearance or approval for marketing. 

Classification decisions and clearance or 

approval for marketing require 

submissions under different sections of 

the FD&C Act. Additionally, the FD&C 

Act, as amended by the FDA 

Amendments Act of 2007 (Public Law 

110–85), requires FDA to collect user 

fees for 513(g) requests for information. 

The guidance document entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff User Fees for 

513(g) Requests for Information’’ assists 

FDA staff and regulated industry by 

describing the user fees associated with 

513(g) requests. The Medical Device 

User Fee Cover Sheet (Form FDA 3601), 

which accompanies the supplemental 

material described in this information 

collection, is approved under OMB 

Control No. 0910–0511 and expires 

April 30, 2016. 

FDA estimates the burden of this 

collection of information as follows: 

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