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 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: omb@cdc.gov.

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 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.