81 FR 81144 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 222 (November 17, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 222 (November 17, 2016)
| Page Range | 81144-81146 | |
| FR Document | 2016-27691 |
[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)] [Notices] [Pages 81144-81146] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27691] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-16BGA; Docket No. CDC-2016-0106] 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 a proposed information collection project entitled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.'' This collection intends to identify risk factors for Zika virus (ZIKV) infection in pregnant women and their infants, assess the risk for adverse maternal, fetal, and infant outcomes associated with ZIKV infection and, assess modifiers of the risk for adverse outcomes among pregnant women and their infants following ZIKV infection. DATES: Written comments must be received on or before January 17, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0106 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 [[Page 81145]] proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 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--New--Pregnancy and Birth Defects Task Force, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 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; sexual transmission, mother- to-child transmission, and laboratory-acquired infections have also been reported. Evidence of human ZIKV infection was observed sporadically 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, evidence of ZIKV has been found 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 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; 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 August 2016, Colombia has reported over 102,000 suspected ZIKV cases, over 18,000 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 ZIKV transmission can be prevented; 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 U.S. Centers for Disease Control and Prevention (CDC) will follow 5,000 women enrolled in the first trimester of pregnancy, their male partners, and their infants, in two to four cities in Colombia where ZIKV transmission is currently ongoing. The primary objectives of the study are to (1) 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; (2) Assess the risk for adverse maternal, fetal, and infant outcomes associated with ZIKV infection and; (3) 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. Pregnant women will be recruited in the first trimester of pregnancy at participating clinics in Colombia's private and public health care systems and followed through their pregnancy, delivery, and immediate postpartum period. Study visits will coincide with routine prenatal care clinic visits (monthly), and at these visits, mothers will be monitored for incident ZIKV infection by collection of blood. In addition, women will be asked to complete a questionnaire about behavioral, sexual, environmental, or other risk factors for ZIKV or adverse pregnancy outcomes and a ZIKV symptoms questionnaire. In between clinic visits (approximately two weeks after the clinic visit), a home visit will be conducted where a urine sample from the pregnant woman will be collected. Mothers will complete a ZIKV symptom questionnaire at the time of the home visit. Fetal ultrasound evaluation will occur once per trimester. If ZIKV is detected during pregnancy, monthly fetal ultrasounds will be conducted and women will provide [[Page 81146]] blood biweekly at the clinic or hospital until there are 2 consecutive negative blood tests for ZIKV. Fetal tissue will be collected for pregnancy losses to assess fetal ZIKV infection. All pregnancy outcomes and any additional testing during pregnancy or in the immediate neonatal period as part of clinical care will be abstracted from medical records. Male partners will be recruited via their pregnant partners around the time of their pregnant partners' enrollment into the study. At enrollment, men will complete a baseline questionnaire and ZIKV symptom questionnaire and provide a blood sample. Urine samples in men will be collected at home every 2 weeks through the second trimester of pregnancy to monitor for incident ZIKV infection. Men will complete a ZIKV symptom questionnaire at the time of each specimen collection. If a man becomes symptomatic, he will be asked to provide a blood sample at the clinic for ZIKV testing. If ZIKV is detected, semen collection at home will be scheduled every two weeks until there are 2 consecutive negative tests, or the end of pregnancy. In addition, if a man's at- home urine sample is positive, he will again be asked to participate in semen collection at home every two weeks until there are 2 consecutive negative tests, or the end of pregnancy. All newborns of mothers participating in the study will be followed from birth to 6 months of age. A blood sample will be collected at delivery or no later than 3 days after delivery. Urine samples and information on infant's symptoms will be collected every 2 weeks at home visits to monitor for ZIKV infection in infancy. Additionally, any infant health conditions or results from medical testing during this 6- month period conducted as part of routine clinical care will be abstracted from medical records. INS and CDC will use the study results to guide their recommendations 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. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Respondents Form name respondents responses per response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Pregnant women................ Pregnant women 6,250 1 5/60 520 eligibility questionnaire. Pregnant women 5,000 1 20/60 1,666 enrollment questionnaire. Adult symptom 5,000 12 5/60 5,000 questionnaire. Pregnant women 5,000 12 15/60 15,000 follow-up questionnaire. Infant symptoms 4,500 4 5/60 1,500 questionnaire. Male partners................. Male partner 5,000 1 5/60 417 eligibility questionnaire. Male enrollment 1,250 1 15/60 312 questionnaire. Adult symptom 1,250 12 5/60 1,250 questionnaire. --------------------------------------------------------------------------------- Total..................... ................ .............. .............. .............. 25,665 ---------------------------------------------------------------------------------------------------------------- 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. 2016-27691 Filed 11-16-16; 8:45 am] BILLING CODE 4163-18-P
![81144 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
investigation. After clinical reports and interview using standard techniques. possible additional testing for GBS-
field observation of a broader range of The sera will be tested for antibodies associated biological markers or other
health endpoints, this larger against suspected infectious pathogens, infectious pathogens as clinically
investigation is now being undertaken such as ZIKV, dengue virus, indicated. If a participant does not
to expand the exploration of the chikungunya virus, influenza virus, provide consent to store the specimens,
association of Zika virus infection with human immunodeficiency virus, and all specimens for that participant will be
not only Guillain-Barre syndrome but Leptospira species bacteria. Urine destroyed once testing for infectious
also other severe neurologic illnesses. specimens will be tested by rRT–PCR to disease pathogens has been completed.
Under this request, case and control identify ZIKV, dengue virus, or As with cases, written consent will also
interviews similar to those conducted chikungunya virus. be obtained to review controls’ medical
under the previously approved If any residual specimens are records, where applicable and available,
information collection will be available from cases, those will also be using a standardized chart abstraction
conducted using the questionnaire obtained and undergo testing for form. Diagnostic test results will be
developed by the investigation team. All infectious pathogens. It is not expected securely transmitted from CDC to PRDH,
cases and controls will be asked that matched controls will have any which will then transmit diagnostic test
questions about activities, antecedent previously collected clinical specimens; results to participants by telephone or
signs and symptoms of illness, and however, in cases where controls had mail, as they prefer.
exposures in the two months prior to specimens collected while seeking Data analysis will focus on potential
onset of neurologic illness for cases and medical care for an acute illness demographic, environmental, and/or
the same time period for their matched experienced within two months of GBS medical risk factors for developing
controls. A calendar will be used to symptom onset of the matching case, neurologic illness, as well as laboratory
orient cases and controls to the time these specimens will also be collected evidence for infection with the
period of interest. and tested for evidence of infection with aforementioned pathogens.
As in the previously approved the aforementioned pathogens. The total number of estimated
information collection activities, sera, Residual samples will be stored after annualized burden hours for this project
urine, and saliva will be collected from infectious testing is complete at the U.S. is 90. There are no other costs to
cases and controls at the time of CDC with an identification number for 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)
Public Health Personnel ................... Severe Neurologic Illness Chart Ab- 10 6 1 60
straction Questionnaire.
General Public .................................. Severe Neurologic Illness Question- 120 1 15/60 30
naire for Cases and Controls.
Total ........................................... ........................................................... ........................ ........................ ........................ 90
Leroy A. Richardson, SUMMARY: The Centers for Disease ADDRESSES: You may submit comments,
Chief, Information Collection Review Office, Control and Prevention (CDC), as part of identified by Docket No. CDC–2016–
Office of Scientific Integrity, Office of the its continuing efforts to reduce public 0106 by any of the following methods:
Associate Director for Science, Office of the burden and maximize the utility of • Federal eRulemaking Portal:
Director, Centers for Disease Control and government information, invites the Regulations.gov. Follow the instructions
Prevention. for submitting comments.
general public and other Federal
[FR Doc. 2016–27692 Filed 11–16–16; 8:45 am]
agencies to take this opportunity to • Mail: Leroy A. Richardson,
BILLING CODE 4163–18–P comment on proposed and/or Information Collection Review Office,
continuing information collections, as Centers for Disease Control and
required by the Paperwork Reduction Prevention, 1600 Clifton Road NE., MS–
DEPARTMENT OF HEALTH AND D74, Atlanta, Georgia 30329.
Act of 1995. This notice invites
HUMAN SERVICES Instructions: All submissions received
comment on a proposed information
collection project entitled ‘‘ZEN must include the agency name and
Centers for Disease Control and Docket Number. All relevant comments
Prevention Colombia Study: Zika in Pregnant
received will be posted without change
Women and Children in Colombia.’’
to Regulations.gov, including any
This collection intends to identify risk
[60Day–17–16BGA; Docket No. CDC–2016– personal information provided. For
0106] factors for Zika virus (ZIKV) infection in
access to the docket to read background
pregnant women and their infants,
documents or comments received, go to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Proposed Data Collection Submitted assess the risk for adverse maternal,
Regulations.gov.
for Public Comment and fetal, and infant outcomes associated Please note: All public comment
Recommendations with ZIKV infection and, assess should be submitted through the
modifiers of the risk for adverse Federal eRulemaking portal
AGENCY: Centers for Disease Control and outcomes among pregnant women and
Prevention (CDC), Department of Health (Regulations.gov) or by U.S. mail to the
their infants following ZIKV infection. address listed above.
and Human Services (HHS).
DATES: Written comments must be FOR FURTHER INFORMATION CONTACT: To
ACTION: Notice with comment period.
received on or before January 17, 2017. request more information on the
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![81146 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
blood biweekly at the clinic or hospital infection. Men will complete a ZIKV 3 days after delivery. Urine samples and
until there are 2 consecutive negative symptom questionnaire at the time of information on infant’s symptoms will
blood tests for ZIKV. Fetal tissue will be each specimen collection. If a man be collected every 2 weeks at home
collected for pregnancy losses to assess becomes symptomatic, he will be asked visits to monitor for ZIKV infection in
fetal ZIKV infection. All pregnancy to provide a blood sample at the clinic infancy. Additionally, any infant health
outcomes and any additional testing for ZIKV testing. If ZIKV is detected, conditions or results from medical
during pregnancy or in the immediate semen collection at home will be testing during this 6-month period
neonatal period as part of clinical care scheduled every two weeks until there conducted as part of routine clinical
will be abstracted from medical records. are 2 consecutive negative tests, or the care will be abstracted from medical
Male partners will be recruited via end of pregnancy. In addition, if a man’s records.
their pregnant partners around the time at-home urine sample is positive, he
of their pregnant partners’ enrollment will again be asked to participate in INS and CDC will use the study
into the study. At enrollment, men will semen collection at home every two results to guide their recommendations
complete a baseline questionnaire and weeks until there are 2 consecutive to prevent ZIKV infection; to improve
ZIKV symptom questionnaire and negative tests, or the end of pregnancy. counseling of patients about risks to
provide a blood sample. Urine samples All newborns of mothers participating themselves, their pregnancies, their
in men will be collected at home every in the study will be followed from birth partners, and their infants; and to help
2 weeks through the second trimester of to 6 months of age. A blood sample will agencies prepare to provide services to
pregnancy to monitor for incident ZIKV be collected at delivery or no later than affected children and families.
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 question- 6,250 1 5/60 520
naire.
Pregnant women enrollment ques- 5,000 1 20/60 1,666
tionnaire.
Adult symptom questionnaire ........... 5,000 12 5/60 5,000
Pregnant women follow-up question- 5,000 12 15/60 15,000
naire.
Infant symptoms questionnaire ........ 4,500 4 5/60 1,500
Male partners .................................... Male partner eligibility questionnaire 5,000 1 5/60 417
Male enrollment questionnaire ......... 1,250 1 15/60 312
Adult symptom questionnaire ........... 1,250 12 5/60 1,250
Total ........................................... ........................................................... ........................ ........................ ........................ 25,665
Leroy A. Richardson, its continuing efforts to reduce public Instructions: All submissions received
Chief, Information Collection Review Office, burden and maximize the utility of must include the agency name and
Office of Scientific Integrity, Office of the government information, invites the Docket Number. All relevant comments
Associate Director for Science, Office of the general public and other Federal received will be posted without change
Director, Centers for Disease Control and agencies to take this opportunity to to Regulations.gov, including any
Prevention. comment on proposed and/or personal information provided. For
[FR Doc. 2016–27691 Filed 11–16–16; 8:45 am] continuing information collections, as access to the docket to read background
BILLING CODE 4163–18–P required by the Paperwork Reduction documents or comments received, go to
Act of 1995. This notice invites Regulations.gov.
comment on ‘‘Data Calls for the Please note: All public comment
DEPARTMENT OF HEALTH AND Laboratory Response Network’’ should be submitted through the
HUMAN SERVICES collected from its members concerning Federal eRulemaking portal
Centers for Disease Control and their capacity to respond to public (Regulations.gov) or by U.S. mail to the
Prevention health threat emergencies. address listed above.
DATES: Written comments must be FOR FURTHER INFORMATION CONTACT: To
[60Day–17–0881; Docket No. CDC–2016– received on or before January 17, 2017. request more information on the
0109] proposed project or to obtain a copy of
ADDRESSES: You may submit comments, the information collection plan and
Proposed Data Collection Submitted identified by Docket No. CDC–2017– instruments, contact the Information
for Public Comment and 0109 by any of the following methods: Collection Review Office, Centers for
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Recommendations • Federal eRulemaking Portal: Disease Control and Prevention, 1600
AGENCY: Centers for Disease Control and Regulations.gov. Follow the instructions Clifton Road NE., MS–D74, Atlanta,
Prevention (CDC), Department of Health for submitting comments. Georgia 30329; phone: 404–639–7570;
and Human Services (HHS). • Mail: Leroy A. Richardson, Email: omb@cdc.gov.
ACTION: Notice with comment period. Information Collection Review Office, SUPPLEMENTARY INFORMATION: Under the
Centers for Disease Control and Paperwork Reduction Act of 1995 (PRA)
SUMMARY: The Centers for Disease Prevention, 1600 Clifton Road NE., MS– (44 U.S.C. 3501–3520), Federal agencies
Control and Prevention (CDC), as part of D74, Atlanta, Georgia 30329. must obtain approval from the Office of
VerDate Sep<11>2014 21:24 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1](https://thefederalregister.org/doc/81_FR_81366/page/3.svg)
Document Created: 2016-11-17 02:59:41
Document Modified: 2016-11-17 02:59:41
| 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 January 17, 2017. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 | 81 FR 81144 |
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