Agency Forms Undergoing Paperwork Reduction Act Review, 36147-36148 [2017-16332]

Download as PDF Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices have been updated, with questions added, removed, and reorganized to decrease response burden and maximize usability. The final VAERS 2.0 Form can be found at https://www.regulations.gov and www.vaers.hhs.gov. During the development of the VAERS 2.0 Form, CDC and FDA sought input from key stakeholders in the Federal government, State Health Officials involved in vaccine safety and vaccine programs, and other public health partners. In addition, the VAERS 2.0 Form was presented to three Federal advisory committees, the Advisory Commission on Childhood Vaccines (September 5, 2014), the National Vaccine Advisory Committee (September 9, 2014), and the Advisory Committee on Immunization Practices (October, 2014). Finally, the final VAERS form was tested with potential users (e.g., physicians, nurses, pharmacists, patients, and parents). On November 24, 2014 HHS/CDC published a notice in the Federal Register (79 FR 69853) announcing the opening of a docket to obtain public comment on the draft VAERS 2.0 Form. HHS/CDC received 19 comments on the draft VAERS 2.0 Form from members of the general public and professional and advocacy organizations. All comments were carefully reviewed and considered in the preparation of the final VAERS form. 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. Dated: July 31, 2017. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. 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). [FR Doc. 2017–16335 Filed 8–2–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–17–17WE] mstockstill on DSK30JT082PROD with NOTICES 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 VerDate Sep<11>2014 16:35 Aug 02, 2017 Jkt 241001 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-Barre 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 36147 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 E:\FR\FM\03AUN1.SGM 03AUN1 36148 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices 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 respondents Type of respondents Form name U.S. Domestic Adults ...................................... Puerto Rico Adults .......................................... Zika Readiness Initiative Questionnaire ........ Zika Readiness 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–2163] Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘ChildResistant Packaging Statements in Drug Product Labeling.’’ This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-thecounter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format. SUMMARY: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 2, 2017. mstockstill on DSK30JT082PROD with NOTICES DATES: ADDRESSES: You may submit comments as follows: VerDate Sep<11>2014 16:35 Aug 02, 2017 Jkt 241001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–D–2163 for ‘‘Child-Resistant Packaging Statements in Drug Product Labeling.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 1,800 600 Number of responses per respondent 1 1 Average burden per response (in hours) 14/60 14/60 Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36147-36148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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
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