82 FR 36147 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 148 (August 3, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 148 (August 3, 2017)
| Page Range | 36147-36148 | |
| FR Document | 2017-16332 |
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)] [Notices] [Pages 36147-36148] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16332] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-17WE] 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 [email protected]. 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 Knowledge, Attitudes, and Practices related to a Domestic Readiness Initiative on Zika Virus Disease--New--Office of the Associate Director for Communication, Centers for Disease Control and Prevention (CDC). Background and Brief Description Since late 2015, Zika has rapidly spread through Puerto Rico. As of November 2016, there have been 35,136 confirmed cases of Zika in Puerto Rico, with 2,797 cases among pregnant women and 67 cases of Guillain- Barr[eacute] caused by Zika. In the continental United States, there have been 4,432 travel-associated cases of Zika and 185 locally- acquired Zika cases in Florida and Texas. Due to the urgent nature of this public health emergency, CDC is implementing a Zika prevention communication and education initiative. The purpose of this survey is to assess a domestic U.S. and Puerto Rico-based communication and education initiative aimed at encouraging at-risk populations to protect themselves and their families from Zika virus infection. CDC will assess the following communication and education objectives: (1) Determine the reach and saturation of the initiative's messages in Puerto Rico and the domestic U.S.; (2) measure the extent to which messages were communicated clearly across multiple channels to advance knowledge and counter misinformation; and (3) monitor individual and community-level awareness, attitudes and likelihood to follow recommended behavior. This data collection includes 2,400 surveys conducted in four geographic locations following peak campaign activity to assess key outcomes of the initiative. The information will be used to make recommendations for improving communication and education regarding the prevention and spread of the Zika virus. Information may also be used to develop presentations, reports, and manuscripts to document the communication effort and lessons learned in order to inform future similar communication efforts. The goal of this project is to determine knowledge, attitudes, and practices related to a Domestic Readiness Initiative on Zika Virus Disease being launched in the United States (U.S.) mainland and Puerto Rico. CDC will seek to gain OMB approval of this new information collection request to conduct a final survey (wave 3) to evaluate the CDC Domestic Readiness Initiative for Zika Virus. The Zika Readiness Initiative campaign has been implemented in two phases with peak campaign activity coinciding with the height of mosquito season during the summer months of 2016 (phase 1) and 2017 (phase 2). OMB granted CDC an emergency review approval in 2016 (OMB Control Number 0920-1136, expiration 3/31/2017) to conduct the first two waves of data collection which captured the effectiveness of the first phase of the campaign. The third wave of data collection will allow CDC to capture the effectiveness of the second phase of the campaign being implemented through late summer/early fall 2017. While the campaign objectives and the call to action remain the same across both phases, campaign materials have been modified between phases based the first two waves of data collection to better address misinformation about Zika and promote a sense of urgency to adopt preventive actions. The third and final wave of data collection is vital to CDC's continued understanding of how the campaign information is received by target audiences and what actions are being taken to prevent Zika virus transmission Findings will be used to improve planning, implementation, refinements and demonstrate outcomes [[Page 36148]] of a Zika Domestic Readiness Initiative communication and education effort. The total estimated annualized burden hours are 560. There are no costs to participants other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- U.S. Domestic Adults.................. Zika Readiness 1,800 1 14/60 Initiative Questionnaire. Puerto Rico Adults.................... Zika Readiness 600 1 14/60 Initiative Questionnaire. ---------------------------------------------------------------------------------------------------------------- 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. 2017-16332 Filed 8-2-17; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices 36147
have been updated, with questions comments should address any of the objectives: (1) Determine the reach and
added, removed, and reorganized to following: (a) Evaluate whether the saturation of the initiative’s messages in
decrease response burden and maximize proposed collection of information is Puerto Rico and the domestic U.S.; (2)
usability. The final VAERS 2.0 Form can necessary for the proper performance of measure the extent to which messages
be found at http://www.regulations.gov the functions of the agency, including were communicated clearly across
and www.vaers.hhs.gov. whether the information will have multiple channels to advance
During the development of the practical utility; (b) Evaluate the knowledge and counter misinformation;
VAERS 2.0 Form, CDC and FDA sought accuracy of the agencies estimate of the and (3) monitor individual and
input from key stakeholders in the burden of the proposed collection of community-level awareness, attitudes
Federal government, State Health information, including the validity of and likelihood to follow recommended
Officials involved in vaccine safety and the methodology and assumptions used; behavior. This data collection includes
vaccine programs, and other public (c) Enhance the quality, utility, and 2,400 surveys conducted in four
health partners. In addition, the VAERS clarity of the information to be geographic locations following peak
2.0 Form was presented to three Federal collected; (d) Minimize the burden of campaign activity to assess key
advisory committees, the Advisory the collection of information on those outcomes of the initiative. The
Commission on Childhood Vaccines who are to respond, including through information will be used to make
(September 5, 2014), the National the use of appropriate automated, recommendations for improving
Vaccine Advisory Committee electronic, mechanical, or other communication and education regarding
(September 9, 2014), and the Advisory technological collection techniques or the prevention and spread of the Zika
Committee on Immunization Practices other forms of information technology, virus. Information may also be used to
(October, 2014). Finally, the final e.g., permitting electronic submission of develop presentations, reports, and
VAERS form was tested with potential responses; and (e) Assess information manuscripts to document the
users (e.g., physicians, nurses, collection costs. communication effort and lessons
pharmacists, patients, and parents). To request additional information on learned in order to inform future similar
On November 24, 2014 HHS/CDC the proposed project or to obtain a copy communication efforts.
published a notice in the Federal of the information collection plan and The goal of this project is to
Register (79 FR 69853) announcing the instruments, call (404) 639–7570 or determine knowledge, attitudes, and
opening of a docket to obtain public send an email to omb@cdc.gov. Written practices related to a Domestic
comment on the draft VAERS 2.0 Form. comments and/or suggestions regarding Readiness Initiative on Zika Virus
HHS/CDC received 19 comments on the the items contained in this notice Disease being launched in the United
draft VAERS 2.0 Form from members of should be directed to the Attention: States (U.S.) mainland and Puerto Rico.
CDC Desk Officer, Office of Management CDC will seek to gain OMB approval
the general public and professional and
and Budget, Washington, DC 20503 or of this new information collection
advocacy organizations. All comments
by fax to (202) 395–5806. Written request to conduct a final survey (wave
were carefully reviewed and considered
comments should be received within 30 3) to evaluate the CDC Domestic
in the preparation of the final VAERS
days of this notice. Readiness Initiative for Zika Virus. The
form.
Zika Readiness Initiative campaign has
Dated: July 31, 2017. Proposed Project been implemented in two phases with
Sandra Cashman, Knowledge, Attitudes, and Practices peak campaign activity coinciding with
Executive Secretary, Centers for Disease related to a Domestic Readiness the height of mosquito season during
Control and Prevention. Initiative on Zika Virus Disease—New— the summer months of 2016 (phase 1)
[FR Doc. 2017–16335 Filed 8–2–17; 8:45 am] Office of the Associate Director for and 2017 (phase 2). OMB granted CDC
BILLING CODE 4163–18–P Communication, Centers for Disease an emergency review approval in 2016
Control and Prevention (CDC). (OMB Control Number 0920–1136,
expiration 3/31/2017) to conduct the
Background and Brief Description first two waves of data collection which
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Since late 2015, Zika has rapidly captured the effectiveness of the first
spread through Puerto Rico. As of phase of the campaign. The third wave
Centers for Disease Control and November 2016, there have been 35,136 of data collection will allow CDC to
Prevention confirmed cases of Zika in Puerto Rico, capture the effectiveness of the second
with 2,797 cases among pregnant phase of the campaign being
[30Day–17–17WE]
women and 67 cases of Guillain-Barré implemented through late summer/early
Agency Forms Undergoing Paperwork caused by Zika. In the continental fall 2017.
Reduction Act Review United States, there have been 4,432 While the campaign objectives and
travel-associated cases of Zika and 185 the call to action remain the same across
The Centers for Disease Control and locally-acquired Zika cases in Florida both phases, campaign materials have
Prevention (CDC) has submitted the and Texas. Due to the urgent nature of been modified between phases based
following information collection request this public health emergency, CDC is the first two waves of data collection to
to the Office of Management and Budget implementing a Zika prevention better address misinformation about
(OMB) for review and approval in communication and education Zika and promote a sense of urgency to
accordance with the Paperwork initiative. adopt preventive actions. The third and
Reduction Act of 1995. The notice for The purpose of this survey is to assess final wave of data collection is vital to
mstockstill on DSK30JT082PROD with NOTICES
the proposed information collection is a domestic U.S. and Puerto Rico-based CDC’s continued understanding of how
published to obtain comments from the communication and education initiative the campaign information is received by
public and affected agencies. aimed at encouraging at-risk target audiences and what actions are
Written comments and suggestions populations to protect themselves and being taken to prevent Zika virus
from the public and affected agencies their families from Zika virus infection. transmission Findings will be used to
concerning the proposed collection of CDC will assess the following improve planning, implementation,
information are encouraged. Your communication and education refinements and demonstrate outcomes
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![36148 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
of a Zika Domestic Readiness Initiative The total estimated annualized
communication and education effort. burden hours are 560. There are no costs
to participants other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
U.S. Domestic Adults ...................................... Zika Readiness Initiative Questionnaire ........ 1,800 1 14/60
Puerto Rico Adults .......................................... Zika Readiness Initiative Questionnaire ........ 600 1 14/60
Leroy A. Richardson, Electronic Submissions Submissions,’’ publicly viewable at
Chief, Information Collection Review Office, Submit electronic comments in the https://www.regulations.gov or at the
Office of Scientific Integrity, Office of the Dockets Management Staff between 9
Associate Director for Science, Office of the
following way:
• Federal eRulemaking Portal: a.m. and 4 p.m., Monday through
Director, Centers for Disease Control and Friday.
Prevention. https://www.regulations.gov. Follow the
[FR Doc. 2017–16332 Filed 8–2–17; 8:45 am] instructions for submitting comments. • Confidential Submissions—To
BILLING CODE 4163–18–P
Comments submitted electronically, submit a comment with confidential
including attachments, to https:// information that you do not wish to be
www.regulations.gov will be posted to made publicly available, submit your
DEPARTMENT OF HEALTH AND the docket unchanged. Because your comments only as a written/paper
HUMAN SERVICES comment will be made public, you are submission. You should submit two
solely responsible for ensuring that your copies total. One copy will include the
Food and Drug Administration comment does not include any information you claim to be confidential
confidential information that you or a with a heading or cover note that states
[Docket No. FDA–2017–D–2163] third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
such as medical information, your or CONFIDENTIAL INFORMATION.’’ The
Child-Resistant Packaging Statements
anyone else’s Social Security number, or Agency will review this copy, including
in Drug Product Labeling; Draft
confidential business information, such the claimed confidential information, in
Guidance for Industry; Availability
as a manufacturing process. Please note its consideration of comments. The
AGENCY: Food and Drug Administration, that if you include your name, contact second copy, which will have the
HHS. information, or other information that claimed confidential information
ACTION: Notice of availability. identifies you in the body of your redacted/blacked out, will be available
comments, that information will be for public viewing and posted on
SUMMARY: The Food and Drug posted on https://www.regulations.gov. https://www.regulations.gov. Submit
Administration (FDA or Agency) is • If you want to submit a comment both copies to the Division of Dockets
announcing the availability of a draft with confidential information that you Management. If you do not wish your
guidance for industry entitled ‘‘Child- do not wish to be made available to the name and contact information to be
Resistant Packaging Statements in Drug public, submit the comment as a made publicly available, you can
Product Labeling.’’ This guidance is written/paper submission and in the provide this information on the cover
intended to assist applicants, manner detailed (see ‘‘Written/Paper sheet and not in the body of your
manufacturers, packagers, and Submissions’’ and ‘‘Instructions’’). comments and you must identify this
distributors who choose to include information as ‘‘confidential.’’ Any
Written/Paper Submissions
child-resistant packaging (CRP) information marked as ‘‘confidential’’
statements in prescription and over-the- Submit written/paper submissions as
will not be disclosed except in
counter human drug product labeling. follows:
accordance with 21 CFR 10.20 and other
The guidance discusses what • Mail/Hand delivery/Courier (for
applicable disclosure law. For more
information should be included to written/paper submissions): Dockets
information about FDA’s posting of
support CRP statements and to help Management Staff (HFA–305), Food and
comments to public dockets, see 80 FR
ensure that such labeling is clear, Drug Administration, 5630 Fishers
56469, September 18, 2015, or access
useful, informative, and, to the extent Lane, Rm. 1061, Rockville, MD 20852.
the information at: https://www.gpo.gov/
possible, consistent in content and • For written/paper comments
submitted to the Dockets Management fdsys/pkg/FR-2015-09-18/pdf/2015-
format. 23389.pdf.
Staff, FDA will post your comment, as
DATES: Although you can comment on well as any attachments, except for Docket: For access to the docket to
any guidance at any time (see 21 CFR information submitted, marked and read background documents or the
10.115(g)(5)), to ensure that the Agency identified, as confidential, if submitted electronic and written/paper comments
considers your comment on this draft as detailed in ‘‘Instructions.’’ received, go to https://
mstockstill on DSK30JT082PROD with NOTICES
guidance before it begins work on the Instructions: All submissions received www.regulations.gov and insert the
final version of the guidance, submit must include the Docket No. FDA– docket number, found in brackets in the
either electronic or written comments 2017–D–2163 for ‘‘Child-Resistant heading of this document, into the
on the draft guidance by October 2, Packaging Statements in Drug Product ‘‘Search’’ box and follow the prompts
2017. Labeling.’’ Received comments will be and/or go to the Dockets Management
ADDRESSES: You may submit comments placed in the docket and, except for Staff, 5630 Fishers Lane, Rm. 1061,
as follows: those submitted as ‘‘Confidential Rockville, MD 20852.
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Document Created: 2017-08-03 07:24:31
Document Modified: 2017-08-03 07:24:31
| 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 | 82 FR 36147 |
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