5760 Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices 

SUPPLEMENTARY INFORMATION: Pursuant 

to the Federal Advisory Committee Act 

(FACA) of 1972 (5 U.S. C., Appendix, as 

amended), and section 2811A of the 

Public Health Service (PHS) Act (42 

U.S. C. 300hh–10a), as added by section 

103 of the Pandemic and All Hazards 

Preparedness Reauthorization Act of 

2013 (Pub. L. 113–5), the HHS 

Secretary, in consultation with the 

Secretary of the U.S. Department of 

Homeland Security, established the 

National Advisory Committee on 

Children and Disasters (NACCD). The 

purpose of the NACCD is to provide 

advice and consultation to the HHS 

Secretary with respect to the medical 

and public health needs of children in 

relation to disasters. The Office of the 

Assistant Secretary for Preparedness 

and Response (ASPR) provides 

management and administrative 

oversight to support the activities of the 

NACCD. 

Background: This public meeting will 

be dedicated to the members voting to 

approve the report of findings of the 

NACCD Surge Capacity Work Group. 

Availability of Materials: The meeting 

agenda and materials will be posted on 

the NACCD Web site at: www.phe.gov/ 

naccd prior to the meeting. 

Procedures for Providing Public Input: 

All written comments must be received 

prior to February 24, 2015. Please 

submit comments via the NACCD 

Contact Form located at www.phe.gov/

NACCDComments. Individuals who 

plan to attend and need special 

assistance should submit a request via 

the NACCD Contact Form located at 

www.phe.gov/NACCDComments. 

Dated: January 22, 2015. 

Nicole Lurie, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2015–01615 Filed 2–2–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–0940] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Generic Clearance for the Collection 

of Qualitative Feedback on Agency 

Service Delivery (OMB No. 0920–0940, 

exp. 06/30/2015)—Extension—Centers 

for Disease Control and Prevention 

(CDC), National Institute for 

Occupational Safety and Health 

(NIOSH), Health Hazard Evaluation 

Program. 

As part of a Federal Government-wide 

effort to streamline the process to seek 

feedback from the public on service 

delivery, the CDC has submitted a 

Generic Information Collection Request 

(Generic ICR): ‘‘Generic Clearance for 

the Collection of Qualitative Feedback 

on Agency Service Delivery ’’ to OMB 

for approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et. 

seq.). 

To request additional information, 

please contact Leroy A. Richardson, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road, MS–D74, 

Atlanta, GA 30333 or send an email to 

omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Title: Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery. 

Abstract: The information collection 

activity will garner qualitative customer 

and stakeholder feedback in an efficient, 

timely manner, in accordance with the 

Administration’s commitment to 

improving service delivery. By 

qualitative feedback we mean 

information that provides useful 

insights on perceptions and opinions, 

but are not statistical surveys that yield 

quantitative results that can be 

generalized to the population of study. 

This feedback will provide insights into 

customer or stakeholder perceptions, 

experiences and expectations, provide 

an early warning of issues with service, 

or focus attention on areas where 

communication, training or changes in 

operations might improve delivery of 

products or services. These collections 

will allow for ongoing, collaborative and 

actionable communications between the 

Agency and its customers and 

stakeholders. It will also allow feedback 

to contribute directly to the 

improvement of program management. 

Feedback collected under this generic 

clearance will provide useful 

information, but it will not yield data 

that can be generalized to the overall 

population. This type of generic 

clearance for qualitative information 

will not be used for quantitative 

information collections that are 

designed to yield reliably actionable 

results, such as monitoring trends over 

time or documenting program 

performance. Such data uses require 

more rigorous designs that address: The 

target population to which 

generalizations will be made, the 

sampling frame, the sample design 

(including stratification and clustering), 

the precision requirements or power 

calculations that justify the proposed 

sample size, the expected response rate, 

methods for assessing potential nonresponse bias, the protocols for data 

collection, and any testing procedures 

that were or will be undertaken prior 

fielding the study. Depending on the 

degree of influence the results are likely 

to have, such collections may still be 

eligible for submission for other generic 

mechanisms that are designed to yield 

quantitative results. 

The Agency received no comments in 

response to the 60-day notice published 

in the Federal Register on April 30, 

2014 (75 FR 24432). 

This is a new collection of 

information. Respondents will be 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices 5761 

screened and selected from Individuals 

and Households, Businesses, 

Organizations, and/or State, Local or 

Tribal Government. There is no cost to 

respondents other than their time. The 

estimated total burden hours for this 

data collection activity are 268. 

Type of collection 

Average 

number of 

respondents 

per activity 

Annual 

frequency 

per response 

Average 

number of 

activities 

Average hours 

per response 

Online surveys, Telephone Surveys, Focus Groups, In person observation/

testing ........................................................................................................... 67 1 5 48/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–02062 Filed 2–2–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry: Notice of 

Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Board 

of Scientific Counselors, National 

Center for Environmental Health/

Agency for Toxic Substances and 

Disease Registry, Department of Health 

and Human Services, has been renewed 

for a 2-year period through May 21, 

2016. 

For information, contact William 

Cibulas, Ph.D., Designated Federal 

Officer, Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry, Department of 

Health and Human Services, 4770 

Buford Highway, Mailstop F61, 

Chamblee, Georgia 30341, telephone 

(770) 488–0662 or fax (770) 488–3385. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–02026 Filed 2–2–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; General Licensing 

Provisions; Section 351(k) Biosimilar 

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 

the information collection in an 

application for a proposed biosimilar 

product and an application for a 

supplement for a proposed 

interchangeable product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 6, 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 

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. 

General Licensing Provisions; Section 

351(k) Biosimilar Applications (OMB 

Control Number 0910–0719)—Extension 

The Patient Protection and Affordable 

Care Act (Affordable Care Act) (Pub. L. 

111–148) contains a subtitle called the 

Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act), 

which amends the Public Health Service 

Act (PHS Act) and establishes an 

abbreviated licensure pathway for 


rljohnson on DSK3VPTVN1PROD with NOTICES