82 FR 41265 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 167 (August 30, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 167 (August 30, 2017)
| Page Range | 41265-41267 | |
| FR Document | 2017-18405 |
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)] [Notices] [Pages 41265-41267] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18405] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-1190; Docket No. CDC-2017-0073] 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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed project titled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.'' DATES: Written comments must be received on or before October 30, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2017- 0073 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted 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 [[Page 41266]] 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start- up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia, (OMB No. 0920-1190, expires 07/31/2019)--Revision--Pregnancy and Birth Defects Task Force, National Center for Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention (CDC). Background and Brief Description Zika virus (ZIKV) infection is a mosquito-borne flavivirus transmitted by Aedes species mosquitoes, and through sexual and mother- to-child transmission. Laboratory-acquired infections have also been reported. Health officials observed sporadic evidence of human ZIKV infection in Africa and Asia prior to 2007, when an outbreak of ZIKV caused an estimated 5,000 infections in the State of Yap, Federated States of Micronesia. Since then, health officials have found evidence of ZIKV in 65 countries and territories, mostly in Central and South America. Common symptoms of ZIKV in humans include rash, fever, arthralgia, and nonpurulent conjunctivitis. The illness is usually mild and self- limited, with symptoms lasting for several days to a week; however, based on previous outbreaks, some infections are asymptomatic. The prevalence of asymptomatic infection in the current Central and South American epidemic is unknown. Although the clinical presentation of ZIKV infection is typically mild, ZIKV infection in pregnancy can cause microcephaly and related brain abnormalities when fetuses are exposed in utero. Other adverse pregnancy outcomes related to ZIKV infection remain under study, and include pregnancy loss, other major birth defects, arthrogryposis, eye abnormalities, and neurologic abnormalities. As the spectrum of adverse health outcomes potentially related to ZIKV infection continues to grow, large gaps remain in our understanding of ZIKV infection in pregnancy. These include the full spectrum of adverse health outcomes in pregnant women, fetuses, and infants associated with ZIKV infection; the relative contributions of sexual transmission and mosquito-borne transmission to occurrence of infections in pregnancy; and variability in the risk of adverse fetal outcomes by gestational week of maternal infection or symptoms of infection. There is an urgency to fill these large gaps in our understanding given the rapidity of the epidemic's spread and the severe health outcomes associated with ZIKV to date. Colombia's Instituto Nacional de Salud (INS) began surveillance for ZIKV in 2015, reporting the first autochthonous transmission in October 2015 in the north of the country. As of December 2016, Colombia has reported over 106,000-suspected ZIKV cases, with over 19,000 of them among pregnant women. With a causal link established between ZIKV infection in pregnancy and microcephaly, there is an urgent need to understand: How to prevent ZIKV transmission; the full spectrum of adverse maternal, fetal, and infant health outcomes associated with ZIKV infection; and risk factors for occurrence of these outcomes. To answer these questions, INS and the CDC will follow 5,000 women enrolled in the first trimester of pregnancy, their male partners, and their infants, in various cities in Colombia where ZIKV transmission is currently ongoing. The primary study objectives are to: (1) Describe the sociodemographic and clinical characteristics of the study population; (2) Identify risk factors for ZIKV infection in pregnant women and their infants. These include behaviors such as use of mosquito-bite prevention measures or condoms, and factors associated with maternal- to-child transmission; (3) Assess the risk for adverse maternal, fetal, and infant outcomes associated with ZIKV infection; (4) Assess modifiers of the risk for adverse outcomes among pregnant women and their infants following ZIKV infection. This includes investigating associations with gestational age at infection, presence of ZIKV symptoms, extended viremia, mode of transmission, prior infections or immunizations, and co-infections. The project aims to enroll approximately 5,000 women, 1,250 male partners, 4,500 newborns, and a subset of 1000 infants/children. Pregnant women will be recruited in the first trimester of pregnancy for study enrollment, followed by assessments during pregnancy (every other week until 32 weeks gestation and monthly thereafter), and within 10 days postpartum. At all visits, participants will complete visit- specific questionnaires. In addition to the questionnaires, at all pregnancy and delivery visits, participants will receive Colombian national recommended clinical care and provide samples for laboratory testing. Researchers will recruit male partners around the time of the pregnant partners' study enrollment, followed by monthly visits until his pregnant partner reaches the third trimester (approximately 27 weeks gestation). If the male partner contracts ZIKV during this time, visits will occur every other week until the partner has two negative consecutive tests for ZIKV or the pregnancy ends. At all study visits, male partners will complete visit-specific [[Page 41267]] questionnaires and provide samples for laboratory testing. Researchers will follow all study-participating mothers' newborns every other week from birth to 6 months of age. At all visits, infants will receive national recommended clinical care (at birth and follow-up visits at 1, 2, and 6 months), provide samples for laboratory testing, and mothers will complete study-specific questionnaires about infant ZIKV symptoms and developmental milestones. During follow-up, infants will also have cranial ultrasounds, their head circumference measured, and hearing and vision tests. For mothers and their infants, researchers will abstract relevant clinical care information from medical records. The revised information collection package includes the following changes. During the data collection period, researchers will follow a subset of 300 infants until 2-years of age. These infants will have answer questionnaires at 6, 12, 18, and 24 months, as well as have other clinical assessments performed to exam developmental delays. Researchers will use the study results use to guide recommendations made by both INS and CDC to prevent ZIKV infection; to improve counseling of patients about risks to themselves, their pregnancies, their partners, and their infants; and to help agencies prepare to provide services to affected children and families. Participation in this study is voluntary and there are no costs to participants other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Respondents Form name Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- Pregnant women................ Pregnant women 3,125 1 5/60 260 eligibility 2,500 1 35/60 1,458 questionnaire. 2,500 15 10/60 6,250 Pregnant women 2,500 8 15/60 5,000 enrollment 2,250 14 10/60 5,250 questionnaire. Adult symptoms questionnaire. Pregnant women follow-up questionnaire. Infant symptoms questionnaire. Ages and Stages 2,250 2 15/60 1,125 Questionnaire: 300 3 15/60 225 2, 4, 6 Month. 300 3 5/60 75 Ages and Stages Questionnaire: 12, 18, 24 Month. Center for Epidemiologic Studies Depression--10. Male partners................. Male partner 2,500 1 5/60 208 eligibility 625 1 25/60 260 questionnaire. 625 7 10/60 729 Male enrollment questionnaire. Adult symptoms questionnaire. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 20,840 ---------------------------------------------------------------------------------------------------------------- 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. 2017-18405 Filed 8-29-17; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41265
releases and determine their health Incidents may occur at businesses or in needs resulting from the incident,
statuses; the community setting; therefore, communication during the release,
2. Identify needs (i.e., medical and respondents may also include business health impact on children and pets, and
basic) of those exposed during the owners, managers, workers, customers, demographic data. Hospital personnel
releases to aid in planning interventions community residents, pet owners, and are asked about the surge, response and
in the community; those passing through the affected area. communication, decontamination, and
3. Assess the impact of the incidents The multidisciplinary ACE team lessons learned.
on health services use and share lessons consisting of staff from ATSDR, the
Depending on the situation, data
learned for use in hospital, local, and Centers for Disease Control and
collected by face-to-face interviews,
state planning for chemical incidents; Prevention (CDC), and the requesting
telephone interviews, written surveys,
and agencies that will be collecting data.
4. Identify cohorts may be followed ATSDR has developed a quickly tailored mailed surveys, or on-line surveys can
and assessed for persistent health effects series of draft survey forms used in the be consider collected. Medical and
resulting from acute releases. field to collect data that will meet the veterinary charts may also be consider
Because each chemical incident is goals of the investigation. ATSDR for review. In rare situations, an
different, it is not possible to predict in collections will be administered based investigation might involve collection of
advance exactly what type of and how on time permitted and urgency. For clinical specimens.
many respondents will be consented example, it is preferable to administer ATSDR anticipates up to four ACE
and interviewed too effectively evaluate the general survey to as many investigations per year. The number of
the incident. Respondents typically respondents as possible. However, if participants has ranged from 30–715,
include, but are not limited to there are time constraints, the shorter averaging about 300 per year. Therefore,
emergency responders such as police, household survey or the ACE Short the total annualized estimated burden
fire, hazardous material technicians, Form may be administered instead. The will be 591 hours per year. Participation
emergency medical services, and individual surveys collect information in ACE investigations is voluntary and
personnel at hospitals where patients about exposure, acute health effects, there are no anticipated costs to
from the incident were treated. health services use, medical history, 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)
Residents, first responders, business General Survey ................................ 800 1 30/60 400
owners, employees, customers. ACE Short Form ............................... 50 1 7/60 6
Residents .......................................... Household Survey ............................ 120 1 15/60 30
Hospital staff ..................................... Hospital Survey ................................ 40 1 30/60 20
Staff from state, local, or tribal health Medical Chart Abstraction Form ...... 250 1 30/60 125
agencies.
Veterinary Chart Abstraction Form .. 30 1 20/60 10
Total ........................................... ........................................................... ........................ ........................ ........................ 591
Leroy A. Richardson, ACTION: Notice with comment period. • Mail: Leroy A. Richardson,
Chief, Information Collection Review Office, Information Collection Review Office,
Office of Scientific Integrity, Office of the SUMMARY: The Centers for Disease Centers for Disease Control and
Associate Director for Science, Office of the Control and Prevention (CDC), as part of Prevention, 1600 Clifton Road NE., MS–
Director, Centers for Disease Control and its continuing efforts to reduce public D74, Atlanta, Georgia 30329.
Prevention.
burden and maximize the utility of Instructions: All submissions received
[FR Doc. 2017–18404 Filed 8–29–17; 8:45 am] government information, invites the must include the agency name and
BILLING CODE 4163–18–P general public and other Federal Docket Number. All relevant comments
agencies to take this opportunity to received will be posted without change
comment on proposed and/or to Regulations.gov, including any
DEPARTMENT OF HEALTH AND continuing information collections, as personal information provided. For
HUMAN SERVICES required by the Paperwork Reduction access to the docket to read background
Centers for Disease Control and Act of 1995. This notice invites documents or comments received, go to
Prevention comment on the proposed project titled Regulations.gov.
‘‘ZEN Colombia Study: Zika in Pregnant Please note: All public comment
Women and Children in Colombia.’’ should be submitted through the
[60Day–17–1190; Docket No. CDC–2017– Federal eRulemaking portal
0073] DATES: Written comments must be
(Regulations.gov) or by U.S. mail to the
mstockstill on DSK30JT082PROD with NOTICES
received on or before October 30, 2017.
Proposed Data Collection Submitted address listed above.
for Public Comment and ADDRESSES: You may submit comments, FOR FURTHER INFORMATION CONTACT: To
Recommendations identified by Docket No. CDC–2017– request more information on the
0073 by any of the following methods: proposed project or to obtain a copy of
AGENCY: Centers for Disease Control and • Federal eRulemaking Portal: the information collection plan and
Prevention (CDC), Department of Health Regulations.gov. Follow the instructions instruments, contact Leroy A.
and Human Services (HHS). for submitting comments. Richardson, Information Collection
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![Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41267
questionnaires and provide samples for ultrasounds, their head circumference performed to exam developmental
laboratory testing. measured, and hearing and vision tests. delays.
Researchers will follow all study- For mothers and their infants, Researchers will use the study results
participating mothers’ newborns every researchers will abstract relevant use to guide recommendations made by
other week from birth to 6 months of clinical care information from medical
age. At all visits, infants will receive both INS and CDC to prevent ZIKV
records.
national recommended clinical care (at The revised information collection infection; to improve counseling of
birth and follow-up visits at 1, 2, and 6 package includes the following changes. patients about risks to themselves, their
months), provide samples for laboratory During the data collection period, pregnancies, their partners, and their
testing, and mothers will complete researchers will follow a subset of 300 infants; and to help agencies prepare to
study-specific questionnaires about infants until 2-years of age. These provide services to affected children
infant ZIKV symptoms and infants will have answer questionnaires and families. Participation in this study
developmental milestones. During at 6, 12, 18, and 24 months, as well as is voluntary and there are no costs to
follow-up, infants will also have cranial have other clinical assessments participants other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Respondents Form name responses per
respondents response hours
respondent (in hours)
Pregnant women ................... Pregnant women eligibility questionnaire .... 3,125 1 5/60 260
Pregnant women enrollment questionnaire 2,500 1 35/60 1,458
Adult symptoms questionnaire ..................... 2,500 15 10/60 6,250
Pregnant women follow-up questionnaire .... 2,500 8 15/60 5,000
Infant symptoms questionnaire .................... 2,250 14 10/60 5,250
Ages and Stages Questionnaire: 2, 4, 6 2,250 2 15/60 1,125
Month. 300 3 15/60 225
Ages and Stages Questionnaire: 12, 18, 24 300 3 5/60 75
Month.
Center for Epidemiologic Studies Depres-
sion—10.
Male partners ........................ Male partner eligibility questionnaire ........... 2,500 1 5/60 208
Male enrollment questionnaire ..................... 625 1 25/60 260
Adult symptoms questionnaire ..................... 625 7 10/60 729
Total ............................... ....................................................................... ........................ ........................ ........................ 20,840
Leroy A. Richardson, Written comments and suggestions send an email to omb@cdc.gov. Written
Chief, Information Collection Review Office, from the public and affected agencies comments and/or suggestions regarding
Office of Scientific Integrity, Office of the concerning the proposed collection of the items contained in this notice
Associate Director for Science, Office of the information are encouraged. Your should be directed to the Attention:
Director, Centers for Disease Control and comments should address any of the CDC Desk Officer, Office of Management
Prevention. following: (a) Evaluate whether the and Budget, Washington, DC 20503 or
[FR Doc. 2017–18405 Filed 8–29–17; 8:45 am] proposed collection of information is by fax to (202) 395–5806. Written
BILLING CODE 4163–18–P necessary for the proper performance of comments should be received within 30
the functions of the agency, including days of this notice.
whether the information will have
DEPARTMENT OF HEALTH AND practical utility; (b) Evaluate the Proposed Project
HUMAN SERVICES accuracy of the agencies estimate of the National Disease Surveillance
burden of the proposed collection of Program II. Disease Summaries (OMB
Centers for Disease Control and information, including the validity of Control Number 0920–0004, Expires
Prevention the methodology and assumptions used; 10/31/2017)—Revision—National
(c) Enhance the quality, utility, and Center for Immunization and
[30Day–17–0004] clarity of the information to be Respiratory Diseases, Centers for
collected; (d) Minimize the burden of Disease Control and Prevention (CDC).
Agency Forms Undergoing Paperwork the collection of information on those
Background and Brief Description
Reduction Act Review who are to respond, including through
the use of appropriate automated, CDC requests a three-year approval for
The Centers for Disease Control and electronic, mechanical, or other the proposed revision of the ‘‘National
Prevention (CDC) has submitted the technological collection techniques or Disease Surveillance Program II. Disease
following information collection request other forms of information technology, Summaries’’ information collection
mstockstill on DSK30JT082PROD with NOTICES
to the Office of Management and Budget e.g., permitting electronic submission of project.
(OMB) for review and approval in responses; and (e) Assess information As with the previous approval, these
accordance with the Paperwork collection costs. data are essential for measuring trends
Reduction Act of 1995. The notice for To request additional information on in diseases, evaluating the effectiveness
the proposed information collection is the proposed project or to obtain a copy of current preventive strategies, and
published to obtain comments from the of the information collection plan and determining the need to modify current
public and affected agencies. instruments, call (404) 639–7570 or preventive measures.
VerDate Sep<11>2014 17:40 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1](https://thefederalregister.org/doc/82_FR_41432/page/3.svg)
Document Created: 2017-08-30 04:08:21
Document Modified: 2017-08-30 04:08:21
| 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 | Written comments must be received on or before October 30, 2017. | |
| 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 | 82 FR 41265 |
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