[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Pages 18630-18631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-16-16XD; Docket No. CDC-2016-0034]


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.

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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 newly proposed 
information collection project entitled ``Practice Patterns Related to 
Opioid Use During Pregnancy and Lactation''. CDC seeks to collect data 
for the purpose of assessing obstetrician-gynecologists' knowledge, 
attitudes, and practices regarding screening for and treatment of 
maternal opioid use surrounding the time of pregnancy. CDC will need a 
one-year clearance from the Office of Management and Budget (OMB) to 
collect the necessary data.

DATES: Written comments must be received on or before May 31, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0034 by any of the following methods:
    Federal eRulemaking Portal: Regulation.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 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

    Practice Patterns Related to Opioid Use During Pregnancy and 
Lactation--New--National Center for Chronic Disease Prevention and 
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Over the past decade, the prevalence of maternal opioid use during 
pregnancy has steadily increased. The use of opioids or other 
psychoactive substances, either by illicit abuse or by nonmedical abuse 
of prescription opioids, increases the risks for health and social 
problems for both mother and infant. For example, maternal substance 
abuse during pregnancy increases the risk of preterm birth, low birth 
weight, perinatal death, and neonatal abstinence syndrome (NAS). For 
many women, and some at-risk women in particular, prenatal visits may 
be the only time they routinely see a physician. Because obstetrician-
gynecologists (OB/GYNs) are the principal health care providers for 
women, OB/GYNs are well situated to screen for substance use and to 
treat or encourage cessation of substance use during pregnancy. Thus, 
it is important to understand current provider knowledge, attitudes, 
and practices regarding maternal opioid use.
    CDC, in collaboration with the American College of Obstetricians 
and Gynecologists (ACOG), plans to conduct a survey to address this gap 
in knowledge. Survey respondents will be ACOG Fellows and Junior 
Fellows who have a current medical license and are in medical practice 
focused on women's health. ACOG is separated into 11 districts, one of 
which represents OB/GYN members who are in the U.S. military. The 
remaining 10 ACOG districts correspond to geographic regions that 
encompass the entire United States and Canada. Survey invitations will 
be sent to a quasi-random sample of ACOG members in each district.
    CDC and ACOG estimate that 1,500 individuals will be contacted in 
order to obtain a study target of 600 respondents. The initial 
invitation will be distributed by email with instructions on completing 
a web-based version of the questionnaire. Three to four months after 
the initial invitation, a paper version of the questionnaire will be

[[Page 18631]]

distributed to individuals who have not completed the online version. 
The estimated number of respondents for the full web-based or paper 
questionnaire is 420 and the estimated burden per response is 15 
minutes. Approximately six weeks after the second recruitment attempt, 
ACOG will distribute a short version of the questionnaire to any non-
responders. The estimated number of responses for the short version of 
the questionnaire is 180 and the estimated burden per response is 5 
minutes. An overall 40% response rate is expected.
    The survey will collect information about provider attitudes and 
beliefs regarding maternal opioid use, their screening and referral 
practices for pregnant or postpartum patients, barriers to screening 
and treating pregnant and postpartum patients for opioid use, and 
resources that are needed to improve treatment and referral.
    No information will be collected about individual patients. Survey 
administration and data management will be conducted by ACOG, and 
participation is voluntary. De-identified response data will be shared 
with CDC for analysis.
    Findings will be used to create recommendations for educational 
programs and patient care. There are no costs to participants other 
than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response (in     (in hours)
                                                                                                            respondent        hours)
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OB/GYNs caring for pregnant women..............  Practice Patterns Related to Opioid Use             420               1           15/60             105
                                                  During Pregnancy and Lactation.
                                                 Practice Patterns Related to Opioid Use             180               1            5/60              15
                                                  During Pregnancy and Lactation (short
                                                  version).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             120
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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. 2016-07226 Filed 3-30-16; 8:45 am]
BILLING CODE 4163-18-P