19668 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Federal Child Support Portal 

Registration. 

OMB No.: 0970–0370. 

Description: The federal Office of 

Child Support Enforcement, Division of 

Federal Systems, maintains the Child 

Support Portal, which contains a variety 

of child support applications to help 

enforce state child support cases. To 

securely access the child support 

applications, authorized users must 

register to use the Child Support 

Services Portal. Information collected 

from the registration form is used to 

authenticate and authorized users. 

The federal Child Support Portal 

Registration information collection 

activities are authorized by 42 U.S.C. 

653(m)(2), which requires the Secretary 

to establish and implement safeguards 

to restrict access to confidential 

information in the Federal Parent 

Locator Service to authorized persons, 

and to restrict use of such information 

to authorized purposes. 

Respondents: Employers, Financial 

Institutions, Insurers, and State 

Agencies 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Registration Screens ....................................................................................................... 183 1 0.15 27.45 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained an 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. Email address infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and, (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–08397 Filed 4–10–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–1082] 

Preparation for International 

Conference on Harmonization Steering 

Committee and Expert Working Group 

Meetings in Fukuoka, Japan; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

regional public meeting entitled 

‘‘Preparation for ICH Steering 

Committee and Expert Working Group 

Meetings in Fukuoka, Japan’’ to provide 

information and receive comments on 

the International Conference on 

Harmonization (ICH) as well as the 

upcoming meetings in Fukuoka, Japan. 

The topics to be discussed are the topics 

for discussion at the forthcoming ICH 

Steering Committee Meeting. The 

purpose of the meeting is to solicit 

public input prior to the next Steering 

Committee and Expert Working Group 

meetings in Fukuoka, Japan, scheduled 

on June 6 through 11, 2015, at which the 

discussion of the topics underway and 

ICH reforms will continue. 

DATES: The public meeting will be held 

on May 15, 2015, from 1 p.m. to 4 p.m. 

Registration to attend the meeting and 

requests for oral presentations must be 

received by May 11, 2015. See the 

SUPPLEMENTARY INFORMATION section for 

information on how to register for the 

meeting. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, Great Room (Rm. 

1503 A), Silver Spring, MD 20993. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Submit either electronic or written 

comments by June 14, 2015. Submit 

electronic comments to http://

www.regulations.gov. Submit written 

comments 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: 

Tracy Porter, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1173, Silver Spring, 

MD 20993, 301–796–7789, FAX: 301– 

847–8443, email: tracy.porter@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The ICH was established in 1990 as a 

joint regulatory/industry project to 

improve, through harmonization, the 

efficiency of the process for developing 

and registering new medicinal products 

in Europe, Japan, and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19669 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

Agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. Members of the ICH 

Steering Committee include the 

European Union; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor, and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; FDA; the Pharmaceutical 

Research and Manufacturers of America; 

Health Canada; Swissmedic; and the 

World Health Organization (as an 

Observer). The ICH process has 

achieved significant harmonization of 

the technical requirements for the 

approval of pharmaceuticals for human 

use in the ICH regions over the past two 

decades. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. (FDA has verified 

the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

II. Meeting Attendance and 

Participation 

A. Registration 

If you wish to attend the meeting, 

visit https://www.eventbrite.com/e/

international-conference-onharmonization-regional-public-meetingtickets-16183519342. Please register for 

the meeting by May 11, 2015. Seating 

may be limited, so early registration is 

recommended. Registration is free and 

will be on a first-come, first-served 

basis. However, FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration on the day of the meetings 

will be based on space availability. 

If you need special accommodations 

because of a disability, please contact 

Tracy Porter (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

B. Requests for Oral Presentations 

Interested persons may present data, 

information, or views orally or in 

writing on issues pending at the public 

meeting. Public oral presentations will 

be scheduled between approximately 

3:30 p.m. and 4 p.m. Time allotted for 

oral presentations may be limited to 5 

minutes. Those desiring to make oral 

presentations should notify Tracy Porter 

(see FOR FURTHER INFORMATION CONTACT) 

by May 11, 2015, and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present; the names and addresses, 

telephone number, fax, and email of 

proposed participants; and an 

indication of the approximate time 

requested to make their presentation. 

The agenda for the public meeting 

will be made available on the Internet 

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

NewsEvents/ucm439475.htm. 

III. Comments 

Interested persons may submit either 

electronic or written comments to the 

public docket (see ADDRESSES) by June 

14, 2015. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday, and will be 

posted to the docket at http://

www.regulations.gov. 

IV. Transcripts 

Please be advised that as soon as a 

meeting transcript is available, FDA will 

post it at http://www.fda.gov/Drugs/

NewsEvents/ucm439475.htm. 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08359 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0363] 

Expedited Access for Premarket 

Approval and De Novo Medical 

Devices Intended for Unmet Medical 

Need for Life Threatening or 

Irreversibly Debilitating Diseases or 

Conditions; Guidance for Industry and 

Food and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of the 

guidance entitled ‘‘Expedited Access for 

Premarket Approval and De Novo 

Medical Devices Intended for Unmet 

Medical Need for Life Threatening or 

Irreversibly Debilitating Diseases or 

Conditions.’’ This guidance outlines 

FDA’s new, voluntary program for 

certain medical devices that 

demonstrate the potential to address 

unmet medical needs for life threatening 

or irreversibly debilitating diseases or 

conditions and that are subject to 

premarket approval (PMA) applications 

or de novo classifications. FDA believes 

that the Expedited Access Pathway 

(EAP) program will help patients have 

more timely access to these medical 

devices by expediting their 

development, assessment, and review, 

while preserving the statutory standard 

of reasonable assurance of safety and 

effectiveness for premarket approval, 

consistent with the Agency’s mission to 

protect and promote public health. The 

document also discusses how the EAP 

program approaches the balance of 

premarket and postmarket data 

collection and incorporates a benefitrisk framework. The EAP program will 

become effective April 15, 2015. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Expedited Access 

for Premarket Approval and De Novo 

Medical Devices Intended for Unmet 

Medical Need for Life Threatening or 

mstockstill on DSK4VPTVN1PROD with NOTICES