65660 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 

Under the Federal Reserve Bank of 

Atlanta heading, the entry for 

IBERIABANK Corporation, Lafayette, 

Louisiana, is revised to read as follows: 

A. Federal Reserve Bank of Atlanta 

(Chapelle Davis, Assistant Vice 

President) 1000 Peachtree Street NE., 

Atlanta, Georgia 30309: 

1. IBERIABANK Corporation, 

Lafayette, Louisiana; to merge with 

Florida Bank Group, Inc., and thereby 

indirectly acquire Florida Bank, both in 

Tampa, Florida. 

Comments on this application must 

be received by November 24, 2014. 

Board of Governors of the Federal Reserve 

System, October 30, 2014. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2014–26216 Filed 11–4–14; 8:45 am] 

BILLING CODE 6210–01–P 

GENERAL SERVICES 

ADMINISTRATION 

[Notice–WW1–2014–04; Docket No. 2014– 

0003; Sequence No. 4] 

World War One Centennial 

Commission; Notification of Upcoming 

Public Advisory Meeting 

AGENCY: World War One Centennial 

Commission, GSA. 

ACTION: Meeting notice. 

SUMMARY: Notice of this meeting is being 

provided according to the requirements 

of the Federal Advisory Committee Act, 

5 U.S.C. App. 10(a)(2). This notice 

provides the schedule and agenda for 

the December 10, 2014 meeting of the 

World War One Centennial Commission 

(the Commission). The meeting is open 

to the public. 

DATES: Effective: December 10, 2014. 

Meeting date: The meeting will be 

held on Wednesday, December 10, 2014 

starting at 12:30 p.m. Central Standard 

Time (CST), and ending no later than 

2:00 p.m. Central Standard Time (CST). 

The meeting will be held at the Pritzker 

Military Museum and Library at 104 

South Michigan Avenue, Chicago, IL 

60603. This location is handicapped 

accessible. The meeting will be open to 

the public and will also be available 

telephonically. Persons wishing to listen 

to the proceedings may dial 712–432– 

1001 and enter access code 474845614. 

Note this is not a toll-free number. 

FOR FURTHER INFORMATION CONTACT: 

Daniel S. Dayton, Designated Federal 

Officer, c/o The Foundation for the 

Commemoration of the World Wars, 701 

Pennsylvania Avenue NW., 123, 

Washington, DC 20004–2608 202–380– 

0725 (note: this is not a toll-free 

number). 

Written Comments may be submitted 

to the Commission and will be made 

part of the permanent record of the 

Commission. Comments must be 

received by 5:00 p.m. Eastern Standard 

Time (EST), December 4, 2014 and may 

be provided by email to daniel.dayton@

worldwar1centennial.org. 

SUPPLEMENTARY INFORMATION: 

Background 

The World War One Centennial 

Commission was established by Public 

Law 112–272, as a commission to 

ensure a suitable observance of the 

centennial of World War I, to provide 

for the designation of memorials to the 

service of members of the United States 

Armed Forces in World War I, and for 

other purposes. Under this authority, 

the Committee will plan, develop, and 

execute programs, projects, and 

activities to commemorate the 

centennial of World War I, encourage 

private organizations and State and 

local governments to organize and 

participate in activities commemorating 

the centennial of World War I, facilitate 

and coordinate activities throughout the 

United States relating to the centennial 

of World War I, serve as a clearinghouse 

for the collection and dissemination of 

information about events and plans for 

the centennial of World War I, and 

develop recommendations for Congress 

and the President for commemorating 

the centennial of World War I. The 

Commission does not have an 

appropriation and operated solely on 

donated funds. 

Agenda: Wednesday, December 10, 

2014. 

Introductions and plans for today’s 

meeting—Designated 

Federal Officer. 

Committee Reports. 

Old Business. 

New Business. 

Public Comments. 

Closing comments. 

Dated: October 31, 2014. 

Daniel S. Dayton, 

Designated Federal Official, World War I 

Centennial Commission. 

[FR Doc. 2014–26298 Filed 11–4–14; 8:45 am] 

BILLING CODE 6820–95–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Final Effect of Designation of a Class 

of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice concerning 

the final effect of the HHS decision to 

designate a class of employees from the 

General Atomics facility in La Jolla, 

California, as an addition to the Special 

Exposure Cohort (SEC) under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

NIOSH, 1090 Tusculum Avenue, MS C– 

46, Cincinnati, OH 45226–1938, 

Telephone 877–222–7570. Information 

requests can also be submitted by email 

to DCAS@CDC.GOV. 

SUPPLEMENTARY INFORMATION: 

Authority: 42 U.S.C. 7384q(b). 42 U.S.C. 

7384l(14)(C). 

On September 25, 2014, as provided 

for under the Secretary of HHS 

designated the following class of 

employees as an addition to the SEC: 

All Atomic Weapons Employees who 

worked for General Atomics at its facility in 

La Jolla, California, during the period from 

January 1, 1960, through December 31, 1969, 

for a number of work days aggregating at least 

250 work days, occurring either solely under 

this employment or in combination with 

work days within the parameters established 

for one or more other classes of employees 

included in the Special Exposure Cohort. 

This designation became effective on 

October 25, 2014. Therefore, beginning 

on October 25, 2014, members of this 

class of employees, defined as reported 

in this notice, became members of the 

SEC. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2014–26340 Filed 11–4–14; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[OMHA–1401–NC] 

Medicare Program; Administrative Law 

Judge Hearing Program for Medicare 

Claim Appeals 

AGENCY: Office of Medicare Hearings 

and Appeals (OMHA), HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

solicits suggestions for addressing the 

substantial growth in the number of 

requests for hearing being filed with the 

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Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 65661 

Office of Medicare Hearings and 

Appeals, and backlog of pending cases. 

DATES: The information solicited in this 

notice must be received at the address 

provided below, no later than 5:00 p.m., 

eastern standard time (e.s.t.) December 

5, 2014. 

ADDRESSES: In commenting, refer to 

‘‘OMHA–1401–NC’’ at the top of your 

comments. Because of staff and resource 

limitations, we cannot accept comments 

by facsimile (FAX) transmission. We 

will not accept comments submitted 

after the comment period. 

You may submit comments in one of 

two ways (to ensure that we do not 

receive duplicate copies, please choose 

only one of the ways listed): 

1. Electronically. You may submit 

electronic comments to 

www.regulations.gov. For new users, 

you can find instructions on how to 

submit comments by selecting ‘‘Are you 

new to this site?’’ at 

www.regulations.gov, then selecting 

‘‘How do I submit a comment?’’ For 

those familiar with 

www.regulations.gov, you can search 

‘‘OMHA–1401–NC’’ and select 

‘‘Comment Now!’’ 

If you are submitting comments 

electronically, we strongly encourage 

you to submit any comments or 

attachments in Microsoft Word format. 

If you must submit a comment in 

Portable Document Format (PDF), we 

strongly encourage you to convert the 

PDF to print-to-PDF format or to use 

some other commonly used searchable 

text format. Please do not submit the 

PDF in a scanned or read-only format. 

Using a print-to-PDF format allows us to 

electronically search and copy certain 

portions of your submissions. 

2. U.S. Mail or commercial delivery. 

You may send written comments to the 

following address only: Office of 

Medicare Hearings and Appeals, 

Department of Health and Human 

Services, Attention: OMHA–1401–NC, 

1700 N. Moore St., Suite 1800, 

Arlington, VA 22209. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

Viewing comments: Comments 

received from members of the public 

(including comments submitted by mail 

or commercial delivery) will be made 

available for public viewing in their 

entirety on the Federal eRulemaking 

portal at www.regulations.gov. 

Information on using 

www.regulations.gov, including 

instructions for accessing agency 

documents, submitting comments, and 

viewing the docket, is available on the 

site under ‘‘Are you new to the site?’’ 

Privacy Note: Because comments will be 

made available for public viewing in their 

entirety on the Federal eRulemaking portal, 

commenters should exercise caution and 

only include in their comments information 

that they wish to make publicly available. 

FOR FURTHER INFORMATION CONTACT: 

Jason Green, by telephone at 1–703– 

235–0124, or by email at jason.green@

hhs.gov (comments will not be accepted 

at this email address). If you use a 

telecommunications device for the deaf 

(TDD) or a text telephone (TTY), call the 

Federal Relay Service (FRS), toll free, at 

1–800–877- 8339. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Office of Medicare Hearings and 

Appeals (OMHA), a staff division within 

the Office of the Secretary of the U.S. 

Department of Health and Human 

Services (HHS), administers the 

nationwide Administrative Law Judge 

hearing program for Medicare claim, 

organization and coverage 

determination, and entitlement appeals 

under sections 1869, 1155, 

1876(c)(5)(B), 1852(g)(5), and 1860D– 

4(h) of the Social Security Act. OMHA 

ensures that Medicare beneficiaries and 

the providers and suppliers that furnish 

items or services to Medicare 

beneficiaries, as well as Medicare 

Advantage Organizations (MAOs) and 

Medicaid State Agencies, have a fair and 

impartial forum to address 

disagreements with Medicare coverage 

and payment determinations made by 

Medicare contractors, MAOs, or Part D 

Plan Sponsors (PDPSs), and 

determinations related to Medicare 

eligibility and entitlement, and incomerelated premium surcharges made by 

the Social Security Administration 

(SSA). 

The Medicare claim, and organization 

and coverage determination appeals 

process consists of four levels of 

administrative review within HHS, and 

a fifth level of review with the Federal 

courts after administrative remedies 

within HHS have been exhausted. The 

first two levels of review are 

administered by the Centers for 

Medicare & Medicaid Services (CMS) 

and conducted by Medicare contractors 

for claim appeals, by MAOs and an 

independent review entity for Part C 

organization determination appeals, or 

by PDPSs and an independent review 

entity for Part D coverage determination 

appeals. The third level of review is 

administered by OMHA and conducted 

by Administrative Law Judges. The 

fourth level of review is administered by 

the HHS Departmental Appeals Board 

(DAB) and conducted by the Medicare 

Appeals Council. In addition, OMHA 

and the DAB administer the second and 

third levels of appeal, respectively, for 

Medicare eligibility, entitlement and 

premium surcharge reconsiderations 

made by SSA; a fourth level of review 

with the Federal courts is available after 

administrative remedies within HHS 

have been exhausted. 

The Medicare, Medicaid, and SCHIP 

Benefits Improvement and Protection 

Act of 2000 (Pub. L. 106–554), which 

added section 1869(d)(1)(A) of the 

Social Security Act, provides for an 

Administrative Law Judge to conduct 

and conclude a hearing and render a 

decision on such hearing within 90 days 

of the date a request for hearing has 

been timely filed. Section 1869(d)(3) of 

the Social Security Act states that, if an 

ALJ does not render a decision by the 

end of the specified timeframe, the 

appellant may request review by the 

Departmental Appeals Board. Likewise, 

if the Departmental Appeals Board does 

not render a decision by the end of the 

specified timeframe, the appellant may 

seek judicial review. OMHA was 

established in July 2005 pursuant to 

section 931 of the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (Pub. L. 108–173), which 

required the transfer of responsibility 

for the Administrative Law Judge 

hearing level of the Medicare claim and 

entitlement appeals process from SSA to 

HHS. OMHA was expected to improve 

service to appellants and reduce the 

average 368-day waiting time for a 

hearing decision that appellants 

experienced with SSA. 

OMHA serves a broad sector of the 

public, including Medicare providers, 

suppliers, and MAOs, and Medicare 

beneficiaries, who are often elderly or 

disabled and among the nation’s most 

vulnerable populations. OMHA 

currently administers its program in five 

field offices, including those located in 

Miami, Florida; Cleveland, Ohio; Irvine, 

California; Arlington, Virginia; and the 

recently established field office in 

Kansas City, Missouri. OMHA uses 

video-teleconferencing (VTC), telephone 

conferencing, and in-person formats to 

provide appellants with hearings. 

At the time OMHA was established, it 

was envisioned that OMHA would 

receive the claim and entitlement 

appeals workload from the Medicare 

Part A and Part B programs, and 

organization determination appeals 

from the Medicare Advantage (Part C) 

program, as well as coverage 

determination appeals from the 

Medicare Prescription Drug (Part D) 

program and appeals of Income Related 

Monthly Adjustment Amount (IRMAA) 

premium surcharges assessed by SSA. 

With this mix of work at the expected 

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65662 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 

levels, OMHA was able to meet the 90- 

day adjudication time frame. 

However, in recent years, OMHA has 

experienced a significant and sustained 

increase in appeals workload that has 

compromised its ability to meet the 90- 

day adjudication time frame. In addition 

to the expanding Medicare beneficiary 

population and utilization of services 

across that population, the increase in 

appeals workload has resulted from a 

number of changes in the Medicare 

claim review and appeals processes in 

recent years, including: 

• Medicaid State Agency (MSA) 

appeals of Medicare coverage denials for 

beneficiaries dually enrolled in both 

Medicare and Medicaid. These appeals 

were previously addressed through a 

demonstration project that employed an 

alternative dispute resolution process to 

determine whether the Medicare or 

Medicaid program would pay for care 

furnished to the dually enrolled 

beneficiaries. The demonstration project 

ended in 2010, and the MSA appeals 

entered the standard administrative 

appeals process, increasing appeals 

workloads throughout the Medicare 

claim appeal process, including at 

OMHA. 

• The fee-for-service Recovery Audit 

(RA) program (also known as the 

Recovery Audit Contractor program), 

which was made permanent by section 

302 of the Tax Relief and Health Care 

Act of 2006 (Pub. L. 109–432). Appeals 

from the RA program began to enter the 

administrative appeals process at the 

CMS contractor levels in fiscal year 

2011. In fiscal year 2012, OMHA began 

receiving hearing requests related to the 

RA program that exceeded projections. 

• CMS has implemented a number of 

changes to enhance its monitoring of 

payment accuracy in the Medicare Part 

A and Part B programs, which have 

increased denial rates and likely 

contributed to increased appeals. For 

example, based on recommendations 

from the HHS Office of Inspector 

General (OIG), in 2009, CMS tightened 

its methodologies related to how it 

calculates the Medicare payment error 

rate, with a view towards improving 

provider claims documentation and 

compliance with Medicare’s billing, 

coverage, and medical necessity 

requirements. In addition, Medicare 

Administrative Contractors (MACs) 

initiated a series of focused medical 

review initiatives, which increased the 

overall number of denied claims. CMS 

also initiated efforts to eliminate 

payment error and fraud based on 

Executive Order 13520 and the 

Improper Payments Elimination and 

Recovery Act of 2010 (Pub. L. 111–204), 

resulting in additional denied claims 

and the identification of overpayments. 

With the increase in overall claim 

denials, the administrative appeals 

process has experienced an overall 

increase in appeal requests. At OMHA, 

the more than anticipated workload 

increase in appealed claims resulted in 

a backlog of appeals (that is, appeals 

that cannot be heard and decided within 

the adjudication time frame) starting in 

fiscal year 2012, with a 42% increase 

from fiscal year 2011 in the number of 

claims appealed to OMHA. In fiscal year 

2013, the number of claims appealed to 

OMHA more than doubled from fiscal 

year 2012, with a 123% increase, further 

contributing to the backlog of cases and 

resulting in a substantial increase in the 

adjudication time frame. The increase in 

appealed claims from the RA program 

was particularly high in fiscal year 

2013, with a 506% increase in appealed 

RA program claims compared to fiscal 

year 2012 appealed claims from the RA 

program, versus a 77% increase in 

appealed claims not related to the RA 

program during that same period of 

time. 

In 2013, CMS issued an Administrator 

Ruling (published on March 18, 2013, 

78 FR 16614) and finalized new rules 

(published on August 19, 2013, 78 FR 

50495) designed to clarify criteria for 

new (fiscal year 2014) Medicare Part A 

inpatient hospital admissions, which 

comprised the disputed issues in a 

majority of RA program appeals, and to 

clarify policies at issue in appeals of 

inpatient claim denials under the 

existing rules. In addition, CMS 

expanded the scope of alternative Part B 

services that could be billed if a Part A 

inpatient admission was denied and, as 

part of the ruling, for a limited time 

allowed hospitals to submit Part B 

claims for those services beyond the 

one-year claim filing deadline. 

Separately, CMS also suspended most 

RA program audits of Part A inpatient 

hospital admissions under the new 

inpatient admission criteria (commonly 

referred to as the two-midnight rule), 

which was effective for inpatient claims 

with admission dates on and after 

October 1, 2013, in order to offer 

providers time to become educated on 

the two-midnight rule. The suspension 

of audits for new admissions was 

extended for claims with dates of 

admission through March 31, 2015, 

pursuant to section 111 of the Protecting 

Access to Medicare Act of 2014 (Pub. L. 

113–93). CMS is also making 

improvements to the RA program that 

are designed to increase the accuracy of 

RA determinations and to reduce the 

burden on providers as well as the 

number of payment denials that 

providers and suppliers appeal. 

OMHA also took measures to mitigate 

the effects of the workload increase at 

the Administrative Law Judge level. One 

of the immediate measures taken was to 

ensure that processing of the relatively 

small numbers of beneficiary-initiated 

appeals was prioritized. For the 

remaining cases, OMHA has deferred 

assignments of new requests for hearing 

until an adjudicator becomes available, 

which will allow appeals to be assigned 

more efficiently on a first in/first out 

basis as an Administrative Law Judge’s 

case docket is able to accommodate 

additional workload. 

On February 12, 2014, OMHA hosted 

a Medicare Appellant Forum (see 

OMHA’s Notice of Meeting, published 

on January 3, 2014, 79 FR 393). The 

Medicare Appellant Forum was 

conducted to provide the appellant 

community with an update on the status 

of OMHA operations; relay information 

on a number of OMHA initiatives 

designed to mitigate the backlog in 

processing Medicare appeals at the 

Administrative Law Judge level of the 

administrative appeals process; and 

provide information on measures that 

appellants could take to make the 

administrative appeals process work 

more efficiently at the Administrative 

Law Judge level. In addition, CMS and 

the DAB participated in the forum and 

shared information on operations at 

their respective appeals levels. A second 

OMHA Medicare Appellant Forum was 

held on October 29, 2014 (see OMHA’s 

Notice of Meeting, published on October 

23, 2014, 79 FR 63398). As conveyed at 

the forums, HHS is committed to 

addressing the challenges facing the 

Medicare claim and entitlement appeals 

process, and has implemented 

initiatives and continues to explore 

additional measures to address the 

workload increase and reduce the 

backlog of appeals. 

Since the February Medicare 

Appellant Forum, OMHA has 

implemented two pilot programs to 

provide appellants with meaningful 

options to address claims at the 

Administrative Law Judge level of 

appeal, in addition to the existing right 

to escalate a request for appeal when the 

adjudication time frame is not met. 

OMHA is providing appellants with an 

option to use statistical sampling during 

the Administrative Law Judge hearing 

process, which will enable appellants to 

obtain a decision on large numbers of 

appealed claims based on a sampling of 

those claims. OMHA is also providing 

appellants with an option for settlement 

conference facilitation, which will 

provide appellants with an independent 

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Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 65663 

OMHA facilitator to discuss potential 

settlement of claims with authorized 

settlement officials. Additional 

information on these two pilots can be 

found on OMHA’s Web site, http://

www.hhs.gov/omha. 

In addition to these initiatives, OMHA 

continues to pursue new case 

processing efficiencies and an electronic 

case adjudication processing 

environment (ECAPE) to bring further 

efficiencies to the appeals process. 

II. Request for Information 

OMHA is seeking input from the 

public on the current initiatives being 

undertaken at the Administrative Law 

Judge level, as well as suggestions for 

additional initiatives which could be 

undertaken at OMHA to address the 

Medicare claim and entitlement appeals 

workload and backlog at the 

Administrative Law Judge level. Input is 

sought on the following topics and 

questions: 

• Are there suggestions related to the 

current initiatives for addressing the 

increased workload and/or backlog of 

appeals at the Administrative Law Judge 

level that comply with current statutory 

authorities and requirements? 

• Are there other suggestions for 

addressing the increased workload and/ 

or backlog of appeals at the 

Administrative Law Judge level that 

comply with current statutory 

authorities and requirements? 

• Are there any current regulations 

that apply to the Administrative Law 

Judge level of the Medicare claim and 

entitlement appeals process that could 

be revised to streamline the 

adjudication process while ensuring 

that parties to the appeals, as defined at 

42 CFR 405.902 and 405.906, are 

afforded opportunities to participate in 

the process and are kept apprised of 

appeals related to claims submitted by 

them or on their behalf? 

(Catalog of Federal Domestic Assistance 

Program No. 93.770, Medicare—Prescription 

Drug Coverage; Program No. 93.773, 

Medicare—Hospital Insurance; and Program 

No. 93.774, Medicare—Supplementary 

Medical Insurance Program) 

Dated: October 30, 2014. 

Nancy J. Griswold, 

Chief Administrative Law Judge, Office of 

Medicare Hearings and Appeals. 

[FR Doc. 2014–26214 Filed 11–4–14; 8:45 am] 

BILLING CODE 4150–46–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number: 93.647] 

Announcement of the Award of a 

Single-Source Program Expansion 

Supplement Grant to Child Trends, 

Inc., in Bethesda, MD 

AGENCY: Office of Planning, Research 

and Evaluation, ACF, HHS. 

ACTION: Announcement of the award of 

a single-source expansion supplement 

grant to Child Trends, Inc., in Bethesda, 

MD, to support activities that promote 

the economic and social well-being of 

individuals, families, and communities. 

SUMMARY: The Administration for 

Children and Families (ACF), Office of 

Planning, Research and Evaluation 

(OPRE) announces the award of a singlesource expansion supplement award in 

the amount of $120,000 to Child Trends, 

Inc., in Bethesda, MD, to support 

activities that will provide researchbased information to improve 

understanding of how to promote the 

economic and social well-being of 

underserved and under-represented 

populations. 

DATES: September 30, 2014 through 

September 29, 2015. 

FOR FURTHER INFORMATION CONTACT: Ann 

Rivera, Social Science Research Analyst, 

Office of Planning, Research & 

Evaluation, Administration for Children 

and Families, 370 L’Enfant Promenade 

SW., Washington, DC 20447; Telephone: 

(202) 401–5506; Email: ann.rivera@

acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under this 

grant program, Child Trends, Inc., a 

non-profit, nonpartisan research center, 

has established the National Research 

Center on Hispanic Children and 

Families, which brings together an 

interdisciplinary team of academic and 

organizational partners to provide 

leadership in culturally competent 

research that can inform policies 

concerning low-income Hispanic 

families and to foster significant 

scholarship regarding the needs and 

experiences of the Hispanic populations 

throughout the nation. This ACFsponsored research center develops 

research products and research-based 

resources that aim to build research 

capacity in the field and to improve 

understanding of Hispanic populations 

in order to inform policy development 

and programmatic responses. 

The award of a single-source 

expansion supplement to this research 

center will support activities to develop 

research-based resources to inform ACF 

program offices, current and future ACF 

grantees, and potential ACF grant 

applicants about the characteristics and 

needs of underserved and underrepresented populations. 

Statutory Authority: Section 1110 of the 

Social Security Act (42 U.S.C. 1310). 

Melody Wayland, 

Senior Grants Policy Specialist, Office of 

Administration, Office of Financial Services/ 

Division of Grants Policy. 

[FR Doc. 2014–26226 Filed 11–4–14; 8:45 am] 

BILLING CODE 4184–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1721] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Investigational 

New Drug Applications 

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 

regulations under which the clinical 

investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products can be 

conducted. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 5, 2015. 

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 

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