80 FR 39437 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 131 (July 9, 2015)

Page Range		39437-39438
FR Document		2015-16772

Federal Register, Volume 80 Issue 131 (Thursday, July 9, 2015)

[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39437-39438]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15MZ]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to 
[email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Project Title--Digital Media and Tobacco Outcomes Survey--National 
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) requests a 
one-year OMB approval to conduct a web-based survey of smokers in the 
United States. This survey will be fielded for purposes of providing 
CDC with new, timely, and relevant information regarding the efficacy 
of the digital advertising component of the 2015 National Tobacco 
Prevention and Control Public Education Campaign (The Campaign). 
Specifically, CDC will evaluate associations between confirmed 
exposures to The Campaign's digital and social media advertising and 
self-reported knowledge, attitudes, beliefs about tobacco use, and 
smoking-related information-seeking behavior.
    This information collection will consist of an online survey of 
demographically similar comparison groups of Internet users who were 
exposed or not exposed to campaign advertising through digital and 
social media during the planned March-July 2015 campaign. Information 
will be collected about smokers' exposure to campaign digital 
advertisements and self-reported knowledge, attitudes, and beliefs 
related to smoking, and smoking-related information seeking. The survey 
will also measure behaviors related to smoking cessation and intentions 
to quit smoking. These data will be used to examine the statistical 
relationships between exposure to the digital campaign and changes in 
outcome variables of interest. This information collection fills 
current gaps in CDC's available data for evaluating the digital 
advertising components of The Campaign which, to date, have been 
limited to measures of ad reach and do not address digital campaign 
impacts on smoking-related knowledge, attitudes, and beliefs, 
intentions, and behaviors related to smoking cessation.
    Data will be collected using the comScore Internet panel, a market 
research company that unobtrusively collects web behavior data on 1+ 
million U.S. Internet users to measure patterns in consumer behaviors 
online. As part of their participation, comScore panelists have 
previously agreed to download software on their computers that enables 
comScore to passively track their web behavior, including Web sites 
visited, searches they conduct, purchases they make, and ads that are 
delivered on sites visited, regardless of whether the ads are clicked 
or not. These data are then aggregated and weighted to provide 
estimates of consumer behaviors online. The panel is a convenience 
sample with panelists largely recruited via nonprobability-based 
sampling methods (e.g., online ads, partner Web sites). However, a 
subsample is recruited via random-digit-dialing to calibrate post-
stratification weights that comScore uses to generate weighted 
demographic distributions that are similar to the U.S. Internet 
population. While our proposed analyses will also utilize such weights, 
all results will be interpreted in light of the sample source and 
direct claims of national representation will not be made.
    Participation is voluntary and there are no costs to respondents 
other than their time. The total estimated annualized burden hours are 
4,134.

[[Page 39438]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
General Population of Internet Users..  Screening and Consent             50,000               1            2/60
                                         Questionnaire.
Eligible participants, ages 18 and      Digital Media and                  5,000               1           20/60
 older in the U.S.                       Tobacco Outcomes
                                         Questionnaire (Wave 1).
                                        Digital Media and                  2,400               1           20/60
                                         Tobacco Outcomes
                                         Questionnaire (Wave 2).
                                       -------------------------------------------------------------------------
                                                                               Total
----------------------------------------------------------------------------------------------------------------


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. 2015-16772 Filed 7-8-15; 8:45 am]
BILLING CODE 4163-18-P

39438 Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)

General Population of Internet Users ............. Screening and Consent Questionnaire .......... 50,000 1 2/60
Eligible participants, ages 18 and older in the Digital Media and Tobacco Outcomes Ques- 5,000 1 20/60
U.S. tionnaire (Wave 1).
Digital Media and Tobacco Outcomes Ques- 2,400 1 20/60
tionnaire (Wave 2).

Total

Leroy A. Richardson, DATES: Submit either electronic or availability of products for patients with
Chief, Information Collection Review Office, written comments on Agency guidances rare diseases and conditions. It is
Office of Scientific Integrity, Office of the at any time. important that these meetings be
Associate Director for Science, Office of the ADDRESSES: Submit written requests for scheduled within a reasonable time,
Director, Centers for Disease Control and conducted effectively, and documented
Prevention.
single copies of the guidance to the
Office of Orphan Products Development where appropriate. This guidance is
[FR Doc. 2015–16772 Filed 7–8–15; 8:45 am] intended to provide consistent
(OOPD), Food and Drug Administration,
BILLING CODE 4163–18–P
10903 New Hampshire Ave., Bldg. 32, procedures to promote well-managed
Rm. 5295, Silver Spring, MD 20993– meetings between OOPD and
0002. Send one self-addressed adhesive stakeholders.
DEPARTMENT OF HEALTH AND Topics addressed in this guidance
label to assist the office in processing
HUMAN SERVICES include: (1) Clarification of what
your requests. The guidance may also be
obtained by mail by calling OOPD at constitutes an ‘‘informal’’ or ‘‘formal’’
Food and Drug Administration meeting, (2) program areas within OOPD
301–796–8660. See the SUPPLEMENTARY
INFORMATION section for electronic
that may be affected by this draft
[Docket No. FDA–2014–D–0313] guidance, (3) procedures for requesting
access to the guidance document.
Submit electronic comments on the and scheduling meetings with OOPD,
Meetings With the Office of Orphan (4) description of what constitutes a
Products Development; Guidance for guidance to http://www.regulations.gov.
Submit written comments on the meeting package, and (5) procedures for
Industry, Researchers, Patient Groups, the conduct and documentation of
and Food and Drug Administration guidance to the Division of Dockets
Management (HFA–305), Food and Drug meetings with OOPD.
Staff; Availability In the Federal Register of April 9,
Administration, 5630 Fishers Lane, Rm.
2014 (79 FR 19623), FDA issued, for
AGENCY: Food and Drug Administration, 1061, Rockville, MD 20852.
public comment, ‘‘Draft Guidance for
HHS. FOR FURTHER INFORMATION CONTACT: Industry, Researchers, Patient Groups,
ACTION: Notice. James D. Bona, Office of Orphan and Food and Drug Administration Staff
Products Development (OOPD), Food on Meetings with the Office of Orphan
SUMMARY: The Food and Drug and Drug Administration, Bldg. 32, Rm. Products Development.’’ The Agency
Administration (FDA) is announcing the 5204, 10903 New Hampshire Ave., issued this draft guidance to assist
availability of a guidance for industry, Silver Spring, MD 20993, 301–796– stakeholders with requesting, preparing,
researchers, patient groups, and FDA 8673, email: james.bona@fda.hhs.gov. scheduling, conducting, and
staff entitled ‘‘Meetings with the Office SUPPLEMENTARY INFORMATION: documenting meetings with OOPD. In
of Orphan Products Development.’’ This particular, the draft guidance provided
guidance provides recommendations to I. Background
clarification on what constitutes an
industry, researchers, patient groups, FDA is announcing the availability of ‘‘informal’’ or ‘‘formal’’ meeting,
and other stakeholders (collectively a guidance for industry, researchers, program areas within OOPD that may be
referred to as ‘‘stakeholders’’) interested patient groups, and FDA staff entitled affected by the guidance, procedures for
in requesting a meeting with FDA’s ‘‘Meetings with the Office of Orphan requesting and scheduling meetings
Office of Orphan Products Development Products Development.’’ Each year, with OOPD, description of what
(OOPD) on issues related to orphan drug OOPD staff participates in meetings constitutes a meeting package, and
designation requests, humanitarian use with stakeholders who seek guidance or procedures for the conduct and
device (HUD) designation requests, rare clarification relating to orphan drug or documentation of meetings.
pediatric disease designation requests, HUD designation requests, OOPD grant We received several comments on the
funding opportunities through the programs, or other rare disease issues. draft guidance. Most comments
Orphan Products Grants Program and These meetings can be ‘‘informal’’ or appreciated the clarification and
the Pediatric Device Consortia Grants ‘‘formal’’ and help build a common explanation provided by the draft
Program, and orphan product patient- understanding on FDA’s thoughts on guidance. Some comments made
srobinson on DSK5SPTVN1PROD with NOTICES

related topics of concern. This guidance orphan products, which may include recommendations to improve clarity.
document is intended to assist these drugs, biological products, devices, or FDA is issuing the draft guidance in
groups with requesting, preparing, medical foods for a rare disease or final form with minor revisions to
scheduling, conducting, and condition. These meetings may improve clarity. This guidance is being
documenting meetings with OOPD. This represent critical points in the orphan issued consistent with FDA’s good
guidance finalizes the draft guidance of product development process and may guidance practices regulation (21 CFR
the same title dated April 2014. even have an impact on the eventual 10.115). The guidance represents the

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Document Created: 2018-02-23 09:14:22
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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 39437

80 FR 39437 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 131 (July 9, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention