Draft 60d FRN

60-Day Federal Register Notice

BILLING CODE: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-XXXX]

[Docket No. CDC-201x-xxxx]

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 “Formative Assessment Regarding Contraception Use in the U.S. Virgin Islands (USVI) in the Context of Zika”.

DATES: Written comments must be received on or before [INSERT DATE 60 DAYS AFTER PUBLICATION DATE IN THE FEDERAL REGISTER].

ADDRESSES: You may submit comments, identified by Docket No. CDC-201x-xxxx 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, N.E., 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, N.E., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; E-mail: [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

Formative Assessment Regarding Contraception Use in the U.S. Virgin Islands (USVI) in the Context of Zika –New- National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

As of October 11, 2016, the U.S. Virgin Islands (USVI) Department of Health reported 1,320 reported cases, and 524 confirmed Zika cases. Ongoing Zika virus transmission in the USVI intensifies the urgent public health need to increase contraceptive access for women who choose to delay or avoid pregnancy as a primary strategy to reduce Zika-related adverse pregnancy and birth outcomes. Among the approximately 12,000 women at risk of unintended pregnancy (women of reproductive age, 18-44 years, who are sexually active and fertile, and not currently desiring a pregnancy) in the USVI, nearly half are not using highly or moderately effective contraception (long acting reversible methods [LARCs], including intrauterine devices [IUDs] and implants, or hormonal methods).

In response to the continued impact of the Zika virus in the USVI, CDC is proposing to develop a comprehensive communication strategy to raise awareness that pregnancy prevention in women who choose to delay or avoid pregnancy is a primary strategy to reduce Zika-related adverse pregnancy and birth outcomes, as well as inform women about available contraceptive methods and services. To ensure the cultural appropriateness and relevance of this approach, CDC plans to conduct a formative assessment with women and men between the ages of 18 and 44 years in the USVI.

The goal of this information collection request is to qualitatively assess current knowledge, attitudes, and beliefs regarding contraception use, in general, and related to Zika virus exposure, in particular, in the USVI. We will explore perceived barriers to accessing contraception and effective ways to provide messages about the contraceptive methods and services available. Additionally, we will seek information on acceptable messaging strategies, including message content and related imagery, effective channels for message dissemination, and appropriate spokespersons and partners. The intended use of the resulting data is for CDC to develop timely, relevant, clear, and engaging materials for the USVI regarding pregnancy prevention during the Zika outbreak.

Focus groups will be used to collect the data. This methodology provides flexible in-depth exploration of the participants’ perceptions and experience and yield descriptions in the participants’ own words. Furthermore, the facilitator will have flexibility to pursue relevant and important issues as they arise during the discussion.

There is no cost to participants other than their time. The total estimated annualized burden hours are 144.

Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Women of reproductive age	Semi-structured qualitative focus group interview—females	60	1	2	120
Men of reproductive age	Semi-structured qualitative focus group interview—males	12	1	2	24
TOTAL					144

Dated:

__________________________________

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