2018-19014. 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 the 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 Pregnancy Risk Assessment Monitoring System (PRAMS). PRAMS provides an important supplement to vital records data by providing state-specific information not available through birth certificate data on maternal behaviors and experiences before, during and after pregnancy on health conditions, prenatal care, postpartum care, access to care, and health insurance status.

DATES:

CDC must receive written comments on or before October 30, 2018.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-201x-xxxx 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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

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, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Proposed Project

The Pregnancy Risk Assessment Monitoring System (PRAMS)—Existing Collection in Use without an OMB Control Number—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) seeks OMB approval to collect information through the Pregnancy Risk Assessment Monitoring System (PRAMS) for three years as a generic clearance. OMB approval for new modules will be submitted through the part of generic clearance mechanism.

PRAMS supplements vital records data by providing state-specific information on maternal behaviors and experiences before, during and after pregnancy. Every month, in each participating state, a sample of women who have recently given birth to a live born or stillborn infant is selected from birth certificates or fetal death files. The sample is stratified based on the state's population of interest to ensure high-risk populations are represented in the data. PRAMS is a state customized mail and telephone survey conducted in 51 sites and covers 83% of all live births in the United States. Information is collected by self-administered mail survey with telephone follow-up for non-responders. Because PRAMS uses standardized data collection methods, it allows data to be compared among states.

The PRAMS survey instrument is based on a core set of questions common across all states. Core questions request information that is not available from vital records; information about health conditions, prenatal care, postpartum care, access to care, or health insurance status; information about contraception, health habits or risk behaviors; and information about other topics such as breastfeeding. In addition, CDC provides participating states with standard questions from optional modules that states may use to customize survey content for their specific needs at the beginning of each Phase of data collection. In addition, on occasion, states may be funded to address emerging topics of interest to collect supplemental data on optional modules of interest. These questions can be used to address state-specific priorities and special topics such as, for example, substance use, including prescription and illicit opioid use, disease epidemics, or other topics related to healthy pregnancy; these supplements can be administered to women identified in the usual manner or via hospital records. States not intending to implement the survey on an ongoing basis, can instead employ a point-in-time survey. Because PRAMS infrastructure was developed to access a specific and vulnerable subpopulation, the PRAMS infrastructure can be rapidly adapted for targeted information collection that would not be feasible with other surveillance methods.

The burden estimate for PRAMS includes two types of information collection: (1) Information collection associated with the PRAMS core questions and predetermined standard questions from optional modules, and (2) information collection associated with optional modules for emerging issues. Participation is voluntary and there are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Types of respondents	Form name	Number of respondents	Number of responses per respondent	Average hours per response (in hours)	Total burden hours
Women who recently delivered a live birth	PRAMS Phase 8 Core Questions	62,514	1	25/60	26,048
	PRAMS Standard Questions on optional modules—predetermined	62,514	1	10/60	10,419
	Estimated burden hours for additional optional modules—emerging	32,530	1	7/60	3,795
Total					40,262

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.