66384 Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Notices 

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: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10371 Cooperative Agreement 

To Support Establishment of StateOperated Health Insurance Exchanges 

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. 

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. 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. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved information collection; Title 

of Information Collection: Cooperative 

Agreement to Support Establishment of 

State-Operated Health Insurance 

Exchanges; Use: Section 1311 of the 

Affordable Care Act provides for grants 

to States for the planning and 

establishment of Marketplaces. Given 

the innovative nature of Marketplaces 

and the statutorily-prescribed 

relationship between the Secretary and 

States in their development and 

operation, it has been 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. These grants are funded through 

the Health Insurance Marketplaces 

Cooperative Agreement to Support 

Establishment of the Affordable Care 

Act’s Health Insurance Exchanges 

(Funding Opportunity Number: IE– 

HBE–12–001). A critical part of this 

guidance and assistance is the collection 

of precise information to measure the 

performance of the individual 

exchanges. 

The revised data collection 

instrument has been developed in 

coordination with the states, based on 

an understanding of their current data 

collection efforts and capabilities. The 

tool will enable us to: (1) Distinguish 

new enrollees from renewals; (2) 

capture language preference (Spanish, 

other language, or no preference) to 

assist in targeting potentially 

underserved individuals; (3) obtain a 

better understanding of enrollment 

activity by certain demographic 

breakdowns to better target our 

activities through more refined crosstabulations of data by age and gender, 

by age and Metal Level, and by financial 

assistance status (with/without) and 

Metal Level; (4) distinguish Special 

Enrollment Period activity for the 2014 

coverage year during the period that 

overlaps with the first 2.5 months of 

Open Enrollment [November 15- 

December 31] in order to avoid 

contamination of 2015 data, to assess 

the extent of Special Enrollment activity 

during the last phase of 2014 activity; 

(5) identify stand-alone dental plans to 

better measure the extent to which 

individuals are enrolling in these 

products in order to provide input into 

ASPE’s monthly report to the public; (6) 

codify providing enrollment data for all 

issuers in the individual marketplaces, 

if available, compared to the template 

that asks only for the top three in the 

individual marketplaces [These data, if 

available, have been provided to us as 

a write-in to the previous template on a 

voluntary basis.]. Form Number: CMS– 

10371 (OMB control number: 0938– 

1119); Frequency: Weekly; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

16; Total Annual Responses: 208; Total 

Annual Hours: 6,240. (For policy 

questions regarding this collection 

contact Dena Puskin 301–492–4342.) 

We are requesting OMB review and 

approval of this collection by November 

15, 2014, with a 180-day approval 

period. Written comments and 

recommendations will be considered 

from the public if received by the date 

and address noted above. 

Dated: November 4, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–26584 Filed 11–5–14; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Anti-Infective Drugs 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). The meeting will be open to the 

public. 

Name of Committee: Anti-Infective 

Drugs 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 December 5, 2014, from 8 a.m. 

to 4:30 p.m. 

Location: The Marriott Inn and 

Conference Center, University of 

Maryland University College, The 

Ballroom, 3501 University Blvd. East, 

Adelphi, MD 20783. The conference 

center’s telephone number is 301–985– 

7300. 

Contact Person: Jennifer Shepherd, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–9001, Fax: 301–847–8533, 

AIDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

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Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Notices 66385 

Agenda: The committee will discuss 

new drug application 206494 for 

ceftazidime-avibactam for injection, 

submitted by Cerexa Inc., for the 

proposed indications of: Complicated 

Intra-abdominal Infections, Complicated 

Urinary Tract Infections, including 

Acute Pyelonephritis and Limited Use 

Indication: Aerobic Gram-negative 

Infections with Limited Treatment 

Options. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 28, 2014. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

November 20, 2014. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by November 21, 2014. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Jennifer 

Shepherd at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 31, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special 

Programs. 

[FR Doc. 2014–26442 Filed 11–6–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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 meetings. 

The meetings 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: Center for Scientific 

Review Special Emphasis Panel; Language 

and Communication. 

Date: December 1, 2014. 

Time: 3:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Andrea B Kelly, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3182, 

MSC 7770, Bethesda, MD 20892, (301) 455– 

1761, kellya2@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Biobehavioral Regulation, Learning 

and Ethology. 

Date: December 4–5, 2014. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Andrea B Kelly, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3182, 

MSC 7770, Bethesda, MD 20892, (301) 455– 

1761, kellya2@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 31, 2014. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–26417 Filed 11–6–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 a meeting of the 

Division of Intramural Research Board 

of Scientific Counselors, NIAID. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

NATIONAL INSTITUTE OF ALLERGY 

AND INFECTIOUS DISEASES, 

including consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Division of Intramural 

Research Board of Scientific Counselors, 

NIAID. 

Date: December 8–10, 2014. 

Time: 8:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 50, Conference Room 1227/1233, 50 

Center Drive, Bethesda, MD 20892. 

Contact Person: Kathryn C. Zoon, Ph.D., 

Director, Division of Intramural Research, 

National Institute of Allergy and Infectious 

Diseases, NIH, Building 31, Room 4A30, 

Bethesda, MD 20892, 301–496–3006, kzoon@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

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