83 FR 25007 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 105 (May 31, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 105 (May 31, 2018)
| Page Range | 25007-25009 | |
| FR Document | 2018-11648 |
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)] [Notices] [Pages 25007-25009] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25007
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of Average
Total burden Total cost
Form name respondents/ hourly wage
hours burden
POCs rate *
Eligibility/Registration Forms ............................................................................ 60 3 $44.89 $135
Data Use Agreement ....................................................................................... 60 3 44.89 135
Nursing Home Site Information Form .............................................................. 60 25 44.89 1,122
Data Files Submission ..................................................................................... 60 60 44.89 2,693
Total .......................................................................................................... 240 91 NA 4,085
* The wage rate in Exhibit 2 is based on May 2017 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor
Statistics, U.S. Dept. of Labor. Mean hourly wages for nursing home POCs are located at https://www.bls.gov/oes/current/naics3_623000.htm.
The hourly wage of $44.89 is the weighted mean of $45.81 (General and Operations Managers 11–1021; N = 40) and $43.04 (Medical and
Health Services Managers 11–9111; N = 20).
Request for Comments SUMMARY: The Centers for Disease proposed project or to obtain a copy of
In accordance with the Paperwork Control and Prevention (CDC), as part of the information collection plan and
Reduction Act, comments on AHRQ’s its continuing effort to reduce public instruments, contact Leroy A.
information collection are requested burden and maximize the utility of Richardson, Information Collection
with regard to any of the following: (a) government information, invites the Review Office, Centers for Disease
Whether the proposed collection of general public and other Federal Control and Prevention, 1600 Clifton
information is necessary for the proper agencies to take an opportunity to Road NE, MS–D74, Atlanta, Georgia
performance of AHRQ’s health care comment on a proposed and/or 30329; phone: 404–639–7570; Email:
research and health care information continuing information collection, as omb@cdc.gov.
dissemination functions, including required by the Paperwork Reduction SUPPLEMENTARY INFORMATION: Under the
whether the information will have Act of 1995. This notice invites Paperwork Reduction Act of 1995 (PRA)
practical utility; (b) the accuracy of comment on a proposed information (44 U.S.C. 3501–3520), Federal agencies
AHRQ’s estimate of burden (including collection project titled StopAnthraxTM. must obtain approval from the Office of
hours and costs) of the proposed This new generic clearance will support Management and Budget (OMB) for each
collection(s) of information; (c) ways to the collection of information from (1) collection of information they conduct
enhance the quality, utility and clarity persons exposed to an intentional or sponsor. In addition, the PRA also
of the information to be collected; and release of anthrax that were given post- requires Federal agencies to provide a
(d) ways to minimize the burden of the exposure prophylactic medical 60-day notice in the Federal Register
collection of information upon the countermeasures—antibiotics or concerning each proposed collection of
respondents, including the use of antibiotics and vaccine and (2) persons information, including each new
automated collection techniques or participating in points of dispensing proposed collection, each proposed
other forms of information technology. (PODs) exercises conducted by state and extension of existing collection of
Comments submitted in response to local health departments. CDC will use information, and each reinstatement of
this notice will be summarized and this information to (1) inform response previously approved information
included in the Agency’s subsequent activities during an anthrax incident collection before submitting the
request for OMB approval of the and (2) improve the StopAnthraxTM collection to the OMB for approval. To
proposed information collection. All program. comply with this requirement, we are
comments will become a matter of DATES: CDC must receive written publishing this notice of a proposed
public record. comments on or before July 30, 2018. data collection as described below.
ADDRESSES: You may submit comments,
The OMB is particularly interested in
Francis D. Chesley, Jr., comments that will help:
Acting Deputy Director. identified by Docket No. CDC–2018–
1. Evaluate whether the proposed
0043 by any of the following methods:
[FR Doc. 2018–11657 Filed 5–30–18; 8:45 am]
• Federal eRulemaking Portal: collection of information is necessary
BILLING CODE 4160–90–P
Regulations.gov. Follow the instructions for the proper performance of the
for submitting comments. functions of the agency, including
• Mail: Jeffrey M. Zirger, Information whether the information will have
DEPARTMENT OF HEALTH AND practical utility;
Collection Review Office, Centers for
HUMAN SERVICES 2. Evaluate the accuracy of the
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta, agency’s estimate of the burden of the
Centers for Disease Control and proposed collection of information,
Prevention Georgia 30329.
Instructions: All submissions received including the validity of the
[60Day–FY–18ACD; Docket No. CDC–2018– must include the agency name and methodology and assumptions used;
0043] Docket Number. CDC will post, without 3. Enhance the quality, utility, and
change, all relevant comments to clarity of the information to be
Proposed Data Collection Submitted collected; and
amozie on DSK3GDR082PROD with NOTICES1
for Public Comment and Regulations.gov.
4. Minimize the burden of the
Recommendations Please note: Submit all comments through collection of information on those who
the Federal eRulemaking portal are to respond, including through the
AGENCY: Centers for Disease Control and (regulations.gov) or by U.S. mail to the
Prevention (CDC), Department of Health use of appropriate automated,
address listed above.
and Human Services (HHS). electronic, mechanical, or other
FOR FURTHER INFORMATION CONTACT: To technological collection techniques or
ACTION: Notice with comment period.
request more information on the other forms of information technology,
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![Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25009
methods). Although it is possible that health departments across the US. The in the jurisdictional exercises through
notifications or responses may be purpose of these tests would be to one or more of the following
intercepted or seen by someone who is evaluate the acceptability of the mechanisms; in-person focus groups,
not part of the team collecting the data, program with members of the potential online survey, online discussion groups.
it is not likely that this will have a major target audience following an anthrax
CDC is requesting approval for this
impact on the respondents’ privacy. incident and to ensure proper
CDC and contractors will also conduct new generic clearance for data
functionality of the StopAnthraxTM
periodic usability and user experience protocols within the system. These tests collection for a period of three years.
tests of StopAnthraxTM in conjunction will occur no more than twice a year The total burden hours for respondents
with points of dispensing (PODs) and feedback on the program will be is 38,000 hours. There are no costs to
exercises conducted by state and local collected from volunteers participating respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Adult MCM recipient ......................... 60-day StopAnthraxTM program ....... 20,000 1 90/60 30,000
POD volunteer participating in user Shortened (10-day) StopAnthrax 4,000 1 30/60 2,000
experience/usability testing of protocol.
shortened StopAnthraxTM protocol.
POD volunteer participating in user Online Survey ................................... 2,000 1 1 2,000
experience/usability testing.
POD volunteer participating in user Discussion/focus groups .................. 2,000 1 2 4,000
experience/usability testing.
Total ........................................... ........................................................... ........................ ........................ ........................ 38,000
Jeffrey M. Zirger, Surveillance System (NASS) data and Health, National Center for Chronic
Acting Chief, Information Collection Review that: (1) Do participate, (2) do Disease Prevention and Health
Office, Office of Scientific Integrity, Office participate and have major data Promotion, Centers for Disease Control
of the Associate Director for Science, Office discrepancies identified through this and Prevention, 4770 Buford Highway
of the Director, Centers for Disease Control process, and/or U3) decline to NE, MS F–74, Atlanta, Georgia 30341.
and Prevention. participate in the data validation Phone: (770) 488–6370. Email: artinfo@
[FR Doc. 2018–11648 Filed 5–30–18; 8:45 am] process. CDC requests comments on this cdc.gov.
BILLING CODE 4163–18–P plan in order to continue to ensure that SUPPLEMENTARY INFORMATION:
the public has access to accurate and
transparent data pursuant to the I. Success Rates
DEPARTMENT OF HEALTH AND Fertility Clinic Success Rate and A. Background
HUMAN SERVICES Certification Act of 1992. Section 2(a) of Public Law 102–493
Centers for Disease Control and DATES: Written comments must be (42 U.S.C. 263a–1(a)), the Fertility
Prevention received on or before July 2, 2018. Clinic Success Rate and Certification
ADDRESSES: You may submit comments, Act of 1992 (FCSRCA), requires that
[Docket No. CDC–2018–0054] identified by Docket No. CDC–2018– each assisted reproductive technology
Proposed Assisted Reproductive 0054 by any of the following methods: (ART) program report annually to the
• Federal eRulemaking Portal: http:// Secretary of the Department of Health
Technology (ART) Success Rates
www.regulations.gov. Follow the and Human Services through the
Reporting and Data Validation
instructions for submitting comments. Centers for Disease Control and
Procedures • Mail: Sara Crawford, Division of Prevention (CDC) pregnancy success
AGENCY: Centers for Disease Control and Reproductive Health, National Center rates achieved through assisted
Prevention (CDC), Department of Health for Chronic Disease Prevention and reproductive technology. The FCSRCA
and Human Services (HHS). Health Promotion, Centers for Disease also requires the CDC to annually
ACTION: Notice with comment period. Control and Prevention, 4770 Buford publish and distribute to the public
Highway NE, MS F–74, Atlanta, Georgia reported pregnancy success rates.
SUMMARY: The Centers for Disease 30341. Phone: (770) 488–6370. Email: According to the FCSRCA, the
Control and Prevention (CDC) in the artinfo@cdc.gov. definitions of pregnancy success rates
Department of Health and Human Instructions: All submissions received should be developed in consultation
Services (HHS) requests comments on a must include the agency name and with appropriate consumer and
plan to (1) revise the definition and Docket Number. All relevant comments professional organizations, should take
characterization of Assisted received will be posted without change into account the effect on success rates
amozie on DSK3GDR082PROD with NOTICES1
Reproductive Technology (ART) success to http://regulations.gov, including any of age, diagnosis, and other significant
rates and (2) introduce clinic validation personal information provided. For factors, and should include the live
footnotes for the annual ART Fertility access to the docket to read background birth rate per attempted ovarian
Clinic Success Rates Report. The documents or comments received, go to stimulation procedure and the live birth
footnotes will identify clinics that are http://www.regulations.gov. rate per successful oocyte retrieval.
selected by CDC to participate in the FOR FURTHER INFORMATION CONTACT: Sara Specifics about the reporting process
validation process of the National ART Crawford, Division of Reproductive and requirements are described in
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Document Created: 2018-05-31 00:48:24
Document Modified: 2018-05-31 00:48:24
| 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 | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before July 30, 2018. | |
| 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] | |
| FR Citation | 83 FR 25007 |
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