81 FR 2864 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 11 (January 19, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 11 (January 19, 2016)
| Page Range | 2864-2866 | |
| FR Document | 2016-00866 |
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)] [Notices] [Pages 2864-2866] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00866] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-15BBU] 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 [[Page 2865]] 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 The Girl Power Project Efficacy Trial--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). The 60-day Federal Register Notice, published on August 12, 2015, was titled ``Efficacy Study of a Mobile Application to Provide Comprehensive and Medically Accurate Sexual Health Information for Adolescent Girls.'' Background and Brief Description Despite drastic reductions in teen births across all racial and ethnic groups, Black and Latino girls continue to have disproportionately high rates of teen births. Increasing girls' access to medically accurate and comprehensive sexual health information is the first step in sustaining momentum in teen pregnancy reduction among all racial and ethnic groups, and in promoting healthy sexual behaviors, especially among minority girls. CDC plans to collect the information needed to test the efficacy of a comprehensive and medically accurate mobile application, titled Crush, in increasing adolescent girls' contraception use and clinic visitation for sexual and reproductive health services. The information disseminated via Crush is similar to the sexual health information youth can access via other Web sites, sexual health promotion educational materials or in clinics. The study will randomize a sample of 1,200 girls, ages 14-18 years, into two groups: the intervention group and the control group. The intervention group will have access to Crush and will receive weekly sexual health information via text to their phones for six months. The control group will have access to a fitness mobile application (``app'') and will receive general health information via text to their phones for six months. Participants are expected to access either app frequently throughout a six month period. As part of the analysis, sexual behavior and key psychosocial factors will be assessed at three points in time: at baseline, and at three- and six-month follow-ups. Efficacy testing will respond to the following research questions: 1. Does exposure to Crush increase consistent contraception use among participants? 2. Does exposure to Crush increase clinic utilization rate among participants? 3. Is media content more attractive to participants than text-based content? For research questions 1 and 2, we hypothesize that participants in the intervention group will report increased intent to use effective contraception and utilize clinic services at three and six months post- intervention. The study will also include a usability testing component to identify the content and features of Crush that are most attractive to participants, the frequency in which Crush was used, and the navigation patterns within Crush. Participants will create an account in the Enrollment Database. This database will host participants' enrollment information, basic demographic information, and will also track their navigation pattern to monitor Crush visitation frequency and visit duration. Navigation data will be used to assess intervention exposure and dosage to specific content areas of Crush. To test real-world utilization of Crush, control group participants will gain access to Crush six months after enrolling into the study, but will not receive weekly text messages. The study will track visitation frequency and duration of each visit. Usability testing will respond to Research Question #3. We hypothesize that participants in the intervention group will spend more time using media features than text-based content. All information will be collected electronically. This study will collect data through two mechanisms: (1) Self-administered online surveys, and (2) the Crush enrollment database. Participants will complete a total of three self-administered online surveys at baseline, and at three and six month follow-ups. Survey questions will assess behavior, attitudes, social norms about sexual behavior, contraception use and clinic utilization, and satisfaction with Crush. The mobile response surveys will be sent to participants via text message which they can complete on a smartphone. The estimated burden per response is 5-15 minutes. Survey responses will be matched by each participant's unique identifying number. Each participant will receive up to two survey reminders starting one week after the initial survey link is sent, for two consecutive weeks. There are minor differences in survey content for the control and intervention groups. Each participant will create a profile in the database upon enrollment. This database will collect initial demographic and contact information, informed consent signatures, and information about the participant's navigation pattern through Crush. Any information entered directly into Crush interactive features will not be stored in the system. The database only collects web analytics data about page visits and duration of each visit by User ID and Internet Protocol (IP) address. Web analytics will only be collected from participants navigating Crush and only when they are logged in as users. Web analytics are generated for any Web site and are a standard evaluation mechanism for assessing the traffic patterns on Web pages. This technology permits development of an objective and quantifiable measure that tracks and records participants' exposure to Crush. This study component does not entail any response burden to participants. Findings will be used to inform the development and delivery of effective health communications. OMB approval is requested for one year. Participation is voluntary and there are no costs to respondents other than their time. The total estimated annualized burden hours are 752. [[Page 2866]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hrs.) ---------------------------------------------------------------------------------------------------------------- Girls 14-18 years old................. Enrollment Questions.... 1,200 1 5/60 Intervention Group.................... Baseline Survey......... 600 1 15/60 3-Month Survey.......... 480 1 10/60 6-Month Survey.......... 384 1 15/60 Control Group......................... Baseline Survey......... 600 1 15/60 3-Month Survey.......... 480 1 10/60 6-Month Survey.......... 384 1 15/60 ---------------------------------------------------------------------------------------------------------------- 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. 2016-00866 Filed 1-15-16; 8:45 am] BILLING CODE 4163-18-P
![2864 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
• BACKGROUND: public comments in response to the would you require the test protocol
• INFORMATION NEEDS: following questions. Please feel free to details to be protected as proprietary
DATES: Electronic or written comments comment on any or all of the questions information?
should be received on or before March below: 11. If applicable, are you willing to
8, 2016. 1. Are there any other types of CSTDs share test results from the application of
ADDRESSES: You may submit comments available that would not fit into the two your air cleaning or filtration
identified by CDC–2015–0075 and categories described, i.e., (1) barrier technologies CSTD test protocol with
Docket Number NIOSH–288 by any of systems, and (2) air-cleaning or filtration NIOSH?
technologies? 12. Are you interested in being a
the following methods:
2. Is there an existing test protocol for collaborative partner with NIOSH on the
• Federal eRulemaking Portal: http://
evaluation of the protective efficacy of development of an air cleaning or
www.regulations.gov. Follow the
air-cleaning or filtration technologies filtration technologies CSTD test
instructions for submitting comments.
CSTDs? Can this test protocol, and/or protocol?
• Mail: National Institute for
the details of the underlying procedures Responses to this notice are not offers
Occupational Safety and Health, NIOSH and cannot be accepted by the
Docket Office, 1090 Tusculum Avenue, and test data be shared with NIOSH?
Please apply the following questions Government to form a binding contract
MS C–34, Cincinnati, OH 45226–1998. or to issue a grant. Information obtained
Instructions: All information received to a protocol you have developed, one
you are aware of, or one you believe to as a result of this RFI may be used by
in response to this notice must include the government for program planning on
the agency name and docket number be feasible to develop:
3. Are there any special restrictions, a non-attribution basis. Please do not
(CDC–2015–0075; NIOSH–288). All include any information that might be
relevant comments received will be limiting assumptions or requirements
for expertise required to conduct the considered proprietary, confidential, or
posted without change to personally identifying (such as home
www.regulations.gov, including any protocol?
4. What are the performance criteria address or social security number).
personal information provided. For
access to the docket to read background used with the protocol tests to Dated: January 12, 2016.
documents or comments received, go to determine acceptability and judge John Howard,
www.regulations.gov. All information conformity? Director, National Institute for Occupational
received in response to this notice will 4. Does the protocol apply to Safety and Health, Centers for Disease Control
also be available for public examination compounding operations, and Prevention.
and copying at the NIOSH Docket administration activities or both? [FR Doc. 2016–00827 Filed 1–15–16; 8:45 am]
5. Does this protocol use a surrogate
Office, 1150 Tusculum Avenue, Room BILLING CODE 4163–19–P
or does it require testing against the
155, Cincinnati, OH 45226.
actual hazardous drugs?
FOR FURTHER INFORMATION CONTACT: 6. If a surrogate is used, DEPARTMENT OF HEALTH AND
Gayle DeBord, NIOSH, Division of a. Does the surrogate represent all HUMAN SERVICES
Applied Research and Technologies, hazardous drugs or a subset?
Robert A. Taft Laboratories, 1090 b. Which criteria are used in selection Centers for Disease Control and
Tusculum Avenue, MS–R2, Cincinnati, of the surrogate? Prevention
Ohio 45226, Phone: (513) 841–4256 [not c. Describe how the selection criteria
a toll-free number], Email: [30Day–16–15BBU]
address the degree to which the
hazardousdrugs@cdc.gov. surrogate or surrogates are Agency Forms Undergoing Paperwork
Background: The purpose of the RFI representative of the class of hazardous Reduction Act Review
is to seek information relative to the drugs to which they apply.
development of a performance d. Does the surrogate introduce any The Centers for Disease Control and
evaluation protocol for CSTDs using air potential worker exposure hazards? Prevention (CDC) has submitted the
cleaning or filtration technologies. The 7. List the hazardous drugs for which following information collection request
draft protocol released for public this protocol has been used. to the Office of Management and Budget
comment on September 8, 2015 [80 FR a. How were these hazardous drugs (OMB) for review and approval in
53802] is applicable to barrier-type selected? accordance with the Paperwork
CSTDs only. This RFI expands the scope b. Were there any hazardous drugs for Reduction Act of 1995. The notice for
of the previous RFI to seek information which the test protocol was not or the proposed information collection is
to support development of a companion would not be successful or compatible? published to obtain comments from the
protocol that would apply to CSTDs c. During protocol application, in public and affected agencies.
using air cleaning or filtration what state were the hazardous drugs, Written comments and suggestions
technologies, thus covering the e.g., full strength as delivered, full from the public and affected agencies
remainder of the currently known CSTD strength reconstituted, patient dose with concerning the proposed collection of
marketplace. diluent, or drug cocktail? information are encouraged. Your
Information Needs: Additional data 8. What procedure(s) can be used to comments should address any of the
and information are needed to assist verify that the protocol is applicable for following: (a) Evaluate whether the
NIOSH to develop or adapt a test new hazardous drugs as they are proposed collection of information is
protocol for evaluating the efficiency of identified and brought to market? necessary for the proper performance of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
air cleaning or filtration technologies 9. Can the test protocol be used the functions of the agency, including
CSTDs. In particular, NIOSH requests effectively for different formulations of whether the information will have
submission of existing test protocols the same active pharmaceutical practical utility; (b) Evaluate the
developed for efficacy testing of air ingredient? accuracy of the agencies estimate of the
cleaning or filtration technologies 10. If applicable, are you willing to burden of the proposed collection of
CSTDs. share details of your test protocol with information, including the validity of
The National Institute for NIOSH? Would you be willing for the the methodology and assumptions used;
Occupational Safety and Health seeks protocol details to be shared publicly or (c) Enhance the quality, utility, and
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![2866 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
Girls 14–18 years old ...................................... Enrollment Questions ..................................... 1,200 1 5/60
Intervention Group .......................................... Baseline Survey ............................................. 600 1 15/60
3-Month Survey .............................................. 480 1 10/60
6-Month Survey .............................................. 384 1 15/60
Control Group ................................................. Baseline Survey ............................................. 600 1 15/60
3-Month Survey .............................................. 480 1 10/60
6-Month Survey .............................................. 384 1 15/60
Leroy A. Richardson, • BACKGROUND: training. Within the overall scope of its
Chief, Information Collection Review Office, • INFORMATION NEEDS: activities, the Center plans to develop a
Office of Scientific Integrity, Office of the DATES: Electronic or written comments document to evaluate current and future
Associate Director for Science, Office of the should be received on or before March sensor technologies used in emergency
Director, Centers for Disease Control and response.
Prevention.
21, 2016.
ADDRESSES: You may submit comments Information Needs: Specifically,
[FR Doc. 2016–00866 Filed 1–15–16; 8:45 am]
identified by CDC–2016–0002 and emergency responders are increasingly
BILLING CODE 4163–18–P
Docket Number NIOSH–214 by any of relying on direct-reading instruments
the following methods: and other sensor technologies to rapidly
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: http:// evaluate potentially life-threatening
www.regulations.gov. Follow the hazards and exposures.
HUMAN SERVICES
instructions for submitting comments. Recommendations to support the proper
Centers for Disease Control and • Mail: National Institute for selection, use, validation, calibration
Prevention Occupational Safety and Health, NIOSH and interpretation of these technologies
Docket Office, 1090 Tusculum Avenue, are lacking. The use of new generations
[Docket Number CDC–2016–0002; NIOSH– of sensors has increased exponentially
MS C–34, Cincinnati, OH 45226–1998.
214] in the past few years. While other
Instructions: All information received
Request for Information on NIOSH in response to this notice must include Federal agencies and organizations have
Center for Direct Reading and Sensor the agency name and docket number developed some recommendations on
Technologies: Sensors for Emergency (CDC–2016–0002; NIOSH–214). All this topic, newer sensor technologies
Response Activities relevant comments received will be have not been thoroughly evaluated and
posted without change to guidance has not focused on
AGENCY: National Institute for www.regulations.gov, including any interpretation of data or appropriate for
Occupational Safety and Health personal information provided. For the intended purpose. Other factors that
(NIOSH) of the Centers for Disease access to the docket to read background need to be considered are that multiple
Control and Prevention (CDC), documents or comments received, go to strategies of environmental sampling
Department of Health and Human www.regulations.gov. All information will be necessary in any response effort;
Services (HHS). received in response to this notice will and that an understanding of the
ACTION: Request for information (RFI) also be available for public examination advantages and limitations of newer
and comment. and copying at the NIOSH Docket direct-reading and sensor technologies
Office, 1150 Tusculum Avenue, Room is needed to select the appropriate
SUMMARY: The National Institute for 155, Cincinnati, OH 45226. strategies. Additionally, training for
Occupational Safety and Health these new sensor technologies and
FOR FURTHER INFORMATION CONTACT:
(NIOSH), part of the Centers for Disease environmental sampling strategies may
Control and Prevention (CDC), requests D. Gayle DeBord, NIOSH, Division of
Applied Research and Technologies, be lacking.
information to enhance the value of the The National Institute for
NIOSH Center for Direct Reading and Robert A. Taft Laboratories, 1090
Tusculum Avenue, MS–R2, Cincinnati, Occupational Safety and Health seeks
Sensor Technologies and is seeking public comments in response to the
input regarding specific issues on the Ohio 45226, Phone: (513) 841–4256 [not
a toll-free number], Email: GDeBord@ following questions. Please feel free to
availability, capability, suitability, comment on any or all of the questions
barriers, limitations, and opportunities cdc.gov.
Background: The NIOSH Center for below:
for current or future direct reading
devices and sensor technologies that can Direct Reading and Sensor Technologies A. Utilization of Sensors in Emergency
be utilized for emergency response. This (http://www.cdc.gov/niosh/topics/drst/ Response
RFI is intended to inform the planning default.html) was created in May 2014
to coordinate the development of A1. What sensors have the most
asabaliauskas on DSK5VPTVN1PROD with NOTICES
of a document to evaluate current and
recommendations on the use of these immediate impact on emergency
future sensor technologies used in
21st century technologies in response?
emergency response.
occupational safety and health. The A2. What applications/situations such
Table of Contents mission of the Center is to develop a as determination of the need for
• DATES: national research agenda, provide evacuation, use of personal protective
• ADDRESSES: guidance on the selection of sensors and equipment, or end-of-service-life of
• INSTRUCTIONS: direct-reading monitors and guidance protective equipment are particularly in
• FOR FURTHER INFORMATION: for validation, quality control and need of sensors?
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Document Created: 2016-01-16 01:11:25
Document Modified: 2016-01-16 01:11:25
| 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 | 81 FR 2864 |
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