[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25007-25009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11648]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-FY-18ACD; Docket No. CDC-2018-0043]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take an opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled StopAnthrax\TM\. This new generic 
clearance will support the collection of information from (1) persons 
exposed to an intentional release of anthrax that were given post-
exposure prophylactic medical countermeasures--antibiotics or 
antibiotics and vaccine and (2) persons participating in points of 
dispensing (PODs) exercises conducted by state and local health 
departments. CDC will use this information to (1) inform response 
activities during an anthrax incident and (2) improve the 
StopAnthrax\TM\ program.

DATES: CDC must receive written comments on or before July 30, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0043 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (regulations.gov) or by U.S. mail to the address 
listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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,

[[Page 25008]]

e.g., permitting electronic submissions of responses.
    5. Assess information collection costs.

Proposed Project

    StopAnthrax\TM\--New--Office of Public Health Preparedness and 
Response (OPHPR), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) Community and 
Health Systems Team (CHST), in collaboration with Oak Ridge Associated 
Universities (ORAU), and the Center for Surveillance, Epidemiology, and 
Laboratory Services (CSELS) developed the StopAnthraxTM 
mobile app push notification program (hereafter referred to as 
StopAnthraxTM) to be activated following an aerosolized 
release of anthrax in the United States. The purpose of this program is 
to use mobile app procedures to collect data about medication adherence 
and adverse drug event symptoms and to enhance self-reporting of 
medical countermeasure (MCM) adverse events to existing surveillance 
systems. The focus of StopAnthraxTM is on MCMs--
ciprofloxacin, doxycycline, amoxicillin, and Anthrax Vaccine Adsorbed 
(AVA)--distributed to communities after an anthrax incident.
    CDC operationalized StopAnthraxTM into a mobile app for 
ease of use with any smart phone. CDC will initiate activation of 
StopAnthraxTM following an anthrax incident and adults 
receiving anthrax MCMs will be able to voluntarily enroll in the 
program. Respondents will provide information through the CDC-developed 
mobile application. StopAnthraxTM will collect information 
necessary to send, personalize, and tailor messages as much as possible 
for the individual respondent (e.g., first name, zip code, which MCM 
the respondent is taking, if they are pregnant or have a child also 
taking MCMs), to understand their level of medication adherence, and 
capture any adverse symptoms attributed to taking the medication or 
anthrax disease. The information collection (IC) will take place within 
the United States in any area(s) affected by an anthrax incident. 
Respondents will include adults who were in or near the affected area 
during the time of the anthrax incident and have been given the select 
MCMs for post-exposure prophylaxis (PEP) of anthrax. Respondents may 
include English or Spanish-speaking single adults, adults with one or 
more children affected, and pregnant women. Respondents enrolled in 
StopAnthraxTM may choose to respond to the IC at any 
location in which they are utilizing their cellular phones (e.g., home, 
school, work). The IC will occur following an anthrax incident and will 
continue for up to 120 days after the incident.
    StopAnthraxTM and the IC will be overseen by CDC. State 
and local public health workers in the affected area will be 
responsible for promoting enrollment into the program utilizing a 
standardized enrollment process. All respondents will voluntarily opt 
into the program by downloading the app from the Apple or Google stores 
and following an easy enrollment process. Once enrolled, respondents 
will answer a short series of questions to ensure they are enrolled in 
the appropriate protocol (i.e., population and MCM-specific). 
Respondents will receive push notifications for a period of up to 60 
days and will periodically be asked questions about their medication 
adherence and any adverse symptoms resulting from taking the MCM or 
from anthrax. Respondents will utilize their cellular telephones to 
send responses back to the system, which will store the information in 
a secure CDC-managed database.
    In a post-incident setting, such as an aerosolized release of 
anthrax, wide-spread administration of MCMs in diverse populations is 
anticipated. CDC and the Food and Drug Administration (FDA) are 
responsible for monitoring the safety of these MCMs. The Vaccine 
Adverse Event Reporting System (VAERS) and the FDA Adverse Event 
Reporting System (FAERS) are two national surveillance systems used to 
monitor adverse drug events. VAERS and FAERS serve as early warning 
systems to detect possible safety issues related to drugs, such as the 
MCMs distributed during an anthrax inhalation incident. However, these 
systems are passive and may not provide the timely information useful 
in a response. Data collected from StopAnthraxTM is intended 
to supplement VAERS and FAERS surveillance and provide near real-time 
safety monitoring and information. CDC and FDA can use the de-
identified information provided by the vendor to more effectively 
respond to the incident. In addition, the program has an added benefit 
for those participating as it provides medication reminders, prompts 
for directing those who experience adverse event symptoms to seek 
medical treatment, and provides relevant health education messages 
about MCMs and anthrax.
    CDC will disseminate de-identified information through a variety of 
methods dependent on the type of anthrax incident and subsequent 
response. During a response, information will be disseminated within 
the CDC response teams and other federal agencies engaged in the 
response, such as FDA. Information will be disseminated to federal 
agency responders through situation reports which may include report 
outs over the phone, data summaries, and action reports that would be 
sent electronically. After the IC period ends (e.g., 
StopAnthraxTM is no longer active), CDC may elect to present 
the findings at a professional conference or submit a manuscript to a 
professional peer-reviewed journal. Data will only be reported in the 
aggregate and would focus on the process and actions taken before and 
during a response. The IC is completely voluntary.
    Any individuals receiving MCMs that elect to enroll and provide 
data will be part of the sample. All recipients will be given the 
opportunity to enroll in StopAnthraxTM. There is no planned 
sample size as this would depend on the scale of the incident and 
enrollment into StopAnthraxTM. Information about 
StopAnthraxTM and enrollment into the program will be 
available to all recipients of MCMs. Information will be collected 
electronically via push notification prompted by a series of questions 
contained within StopAnthraxTM.
    StopAnthraxTM spans a total of 60 days. Those enrolled 
will not be asked to respond to questions every day. The amount of time 
that one may take in responding to the messages will vary depending on 
the individual's situation (i.e., they may be asked a series of follow 
up questions based on their responses). On average, it is not expected 
to take longer than 1.5 hours for one respondent to respond to all 
questions contained in the 60 day program.
    All respondents will be informed that their participation is 
voluntary, and they can opt out at any time after enrollment; their 
information will be treated in a secure manner, and protected to the 
extent allowed by law. Although some respondents may feel some level of 
embarrassment in indicating they experienced certain adverse event 
symptoms (e.g., severe diarrhea), none of the information being 
collected is of a highly sensitive nature. Data will be housed on 
secure servers to which only project staff from CDC and contractors 
will have access, and all data will be de-identified in any reports or 
other materials produced by CDC. The IC is expected to have limited 
impact on respondents' privacy. Mobile apps are a relatively private 
method in which to collect information (as compared to focus groups and 
other

[[Page 25009]]

methods). Although it is possible that notifications or responses may 
be intercepted or seen by someone who is not part of the team 
collecting the data, it is not likely that this will have a major 
impact on the respondents' privacy.
    CDC and contractors will also conduct periodic usability and user 
experience tests of StopAnthraxTM in conjunction with points 
of dispensing (PODs) exercises conducted by state and local health 
departments across the US. The purpose of these tests would be to 
evaluate the acceptability of the program with members of the potential 
target audience following an anthrax incident and to ensure proper 
functionality of the StopAnthraxTM protocols within the 
system. These tests will occur no more than twice a year and feedback 
on the program will be collected from volunteers participating in the 
jurisdictional exercises through one or more of the following 
mechanisms; in-person focus groups, online survey, online discussion 
groups.
    CDC is requesting approval for this new generic clearance for data 
collection for a period of three years. The total burden hours for 
respondents is 38,000 hours. There are no costs to respondents other 
than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Adult MCM recipient...........  60-day                    20,000               1           90/60          30,000
                                 StopAnthraxTM
                                 program.
POD volunteer participating in  Shortened (10-             4,000               1           30/60           2,000
 user experience/usability       day)
 testing of shortened            StopAnthrax
 StopAnthraxTM protocol.         protocol.
POD volunteer participating in  Online Survey...           2,000               1               1           2,000
 user experience/usability
 testing.
POD volunteer participating in  Discussion/focus           2,000               1               2           4,000
 user experience/usability       groups.
 testing.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          38,000
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting 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. 2018-11648 Filed 5-30-18; 8:45 am]
 BILLING CODE 4163-18-P